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REGIONAL BARIATRICS A New Beginning


TABLE OF CONTENTS TABLE OF CONTENTS .............................................................................................................................................. 2 OUR COMMITMENT TO QUALITY ........................................................................................................................... 3 ACCREDITATION BY THE AMERICAN COLLEGE OF SURGEONS ............................................................................ 3 OUR APPROACH TO PATIENT CARE ....................................................................................................................... 4 YOUR WEIGHT LOSS SURGICAL OPTIONS ............................................................................................................ 5 PATIENT SELECTION GUIDELINES .......................................................................................................................... 12 PATIENT PATHWAY TO SURGERY ........................................................................................................................ 14 RESOURCES ........................................................................................................................................................... 27 APPENDIX #1 – RESULTS AND COMPLICATION RATES........................................................................................ 28 APPENDIX #2 – REQUIRED COMPONENTS FOR YOUR APPLICATION PACKET................................................... 29 APPENDIX #3 – RECOMMENDED ANNUAL BLOOD TESTS .................................................................................. 31 APPENDIX #4 – FOLLOW-UP FORM .................................................................................................................... 32 APPENDIX #5 – SGB INFORMED CONSENT FORM .............................................................................................. 33 APPENDIX #6 – AGB INFORMED CONSENT FORM ............................................................................................. 45 APPENDIX #7 – RNY INFORMED CONSENT FORM ...…………………………………………………………...49 APPENDIX #8 – SLEEVE GASTRECTOMY CONSENT FORM …………………………………………………….61

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OUR COMMITMENT TO QUALITY ACCREDITATION BY THE AMERICAN COLLEGE OF SURGEONS Regional Bariatrics has been approved for Bariatric Surgery Accreditation by the Bariatric Surgery Center Network (BSCN) Accreditation Program of the American College of Surgeons (ACS). We are the first bariatric program in North Carolina to achieve this quality accreditation and the only one in the world to be accredited for the SleeveGastric Bypass surgery, also known as the mini-gastric bypass. Our program was established in 2002, and the Center’s surgeons, Thomas Walsh, MD and James Dasher, MD are Board Certified and Fellows of the American College of Surgeons. They have successfully completed more than 850 bariatric procedures since the program’s inception and have achieved clinical outcomes which far exceed national averages. The ACS BSCN Accreditation Program provides confirmation that a bariatric surgery center has demonstrated its commitment to providing the highest quality care for its bariatric patients. Accredited bariatric surgery centers provide not only the hospital resources necessary for optimal care of morbidly obese patients, but also the support and resources necessary to address the entire spectrum of care and needs of bariatric patients, including the pre-hospital phase, treatment process and post-operative care. To attain accreditation, Regional Bariatrics was required to undergo onsite verification of quality by experienced bariatric surgeons, who reviewed the program’s structure, process and quality of data using the current ACS Bariatric Surgery Center Network Accreditation Program Manual as a guideline. Our innovative surgeons and experienced staff are committed to providing the safest and highest quality care to patients, including excellent service and patient satisfaction. To continually refine our standards of care, we monitor and measure our performance against our own rigorous standards, as well as industry benchmarks.

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OUR APPROACH TO PATIENT CARE Regional Bariatrics is committed to a comprehensive, multidisciplinary approach to patient care. Preoperatively, all patients are evaluated by their primary medical doctor who provides a complete history, physical and documentation of previous non-surgical weight-loss attempts. All patients receive a complete psychological evaluation by a psychiatrist or psychologist. We are dedicated to providing preoperative nutrition education and exercise instruction to all patients. Our surgeons thoroughly evaluate patients prior to surgery, and when indicated, various specialists, such as cardiologists, are involved in both the preoperative, as well as postoperative care of patients. Support group meetings are available for patients and feature speakers on a diverse selection of topics appropriate for weight-loss surgery patients. For example, we periodically invite plastic surgeons to provide informational sessions surrounding post weight-loss body contouring. To ensure our multidisciplinary team communicates frequently, a Bariatric Steering Committee meets to review the program and patient care. This steering committee includes the surgeons, operating room staff, nursing, physical therapy, dietary and key hospital administration. The information that follows in this manual is designed to help potential weight-loss surgery patients make an educated decision regarding surgery. It is strongly recommended that prospective patients also attend: Informational Seminar Our free informational seminars provide an overview of the Regional Bariatrics program. They are held at our office located at 710 North Elm Street, High Point, NC. Register for these seminars by calling our office at (877) 878-7644 or (336) 878-6340, or by visiting our website. Support Group Meeting Our patient support groups provide ongoing support for patients who have received bariatric surgery. They are designed to effectively address our patients’ commitment and challenges to new lifestyle choices. At these meetings, you will be surrounded by people who understand and support your goals, receive up-to-date weightloss information, consider issues in context of the history of obesity and have the opportunity to discuss personal or professional issues that arise from the consequences of bariatric surgery. Group members also learn and are given reinforcement for nutrition, exercise and behavior modification skills. Support sessions have been shown to directly increase the chances of short- and long-term patient success following bariatric surgery and we highly encourage you and your significant other to make the commitment to regularly attend these meetings. Register for our next support group by calling our office at (877) 878-7644 or (336) 878-6340. Patients who are dedicated to a lifetime of postoperative follow-up have the healthiest and most successful weight loss. For this reason, consistent follow-up is essential and expected.

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YOUR WEIGHT-LOSS SURGICAL OPTIONS There are four surgical weight-loss options available for patients at Regional Bariatrics. They are: Sleeve-Gastric Bypass (SGB), commonly referred to as the Mini-Gastric Bypass (MGB), Roux en Y Gastric Bypass (RNY), Sleeve Gastrectomy and Adjustable Gastric Banding (AGB). Excellent weight-loss results can be realized by any of these procedures, particularly when patients are dedicated to following their surgeon’s post-operative diet and follow-up recommendations. Programs such as ours, with excellent safety profiles, partnered with patients who are committed to following these recommendations, create the very best surgical weight-loss results.

An Overview of the Sleeve-Gastric Bypass (SGB) The Sleeve-Gastric Bypass was first performed in 1997. Since that time, more than 5,000 procedures have been performed worldwide. Regional Bariatrics has been the region’s primary center since June 2002 and has treated more than 850 patients with excellent weight-loss results and an impressive safety profile. Such success is possible because the Center’s surgeons insist on an extensive preoperative evaluation, assuring that only the most appropriate patients, with the best chance for success, are offered surgery. Surgery is performed laparoscopically, with just five mini incisions contributing to far less post-operative surgical pain and a quicker recovery. This procedure is usually completed in one hour, and most patients are discharged the day after surgery. For a patient weighing 300 pounds, the average weight loss in the first year after surgery is 120 to 140 pounds. Additionally, weight loss often continues for up to 18 to 24 months after surgery. Many preexisting medical conditions -- such as Type II Diabetes, Hypertension, Sleep Apnea and more -- are corrected or greatly improved following this surgery. For example, about 90 percent of diabetic patients are off all diabetes medicine and have normal blood sugar tests at one year after surgery. MGB patients are followed lifelong to assure safe and healthy weight loss. Our multidisciplinary support team exists to help patients maintain a healthy postoperative lifestyle. Procedure Details – Sleeve-Gastric Bypass SGB patients undergo general anesthesia using a short-acting intravenous medication. Compared to gas anesthetics, this lessens the risk of retaining the medication in the body, which can result in postoperative breathing difficulties. Once asleep, five one-inch incisions are made, and the abdomen is filled with air. The surgeons inspect the inside of the abdomen, then staple the stomach to form a long, narrow pouch. This stapling creates a smaller portion of stomach that will be used to receive food. This is the restrictive portion of the surgery and allows only a small amount of food or liquid to be consumed at any one time. The long, narrow stomach pouch is actually stapled and separated from the “old” stomach, so it is not possible to “pop” the seam open by eating too much. This was a problem with an older form of surgery known as the vertical banded gastroplasty. No portion of the stomach is removed during a SGB surgery. The “old” portion of the stomach and its blood supply are still intact. This allows the surgery to be reversible or revisable. The next step is to bypass some portion of the small intestine. This is the malabsorptive portion of the surgery. When food is being digested and bypasses a portion of the intestine, calories are not absorbed, therefore contributing to weight loss. “Typical” patients have approximately six feet of small intestine bypassed. This part

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of the intestine is connected to the long stomach pouch using staples as well as a hand-sewn surgical technique that minimizes the risk of a postoperative leak. Blood loss is generally characterized as minimal. Some patients will have a small, soft plastic drainage tube coming out of one of the mini abdominal incisions. This drain is placed to remove any residual blood that has collected inside the abdomen that can be a significant irritant to the abdominal wall lining. This drain tube is generally removed in the hospital, at the bedside the morning after surgery. Procedure Details – Roux en Y Gastric Bypass Another option for creation of a gastric bypass is the Roux en Y Gastric Bypass. This operation is commonly done in many centers around the world. The main difference between a RNYGB and a SGB is that the bile enters the bowel further down the gastrointestinal tract. This extra step is accomplished by dividing the bowel into two pieces after the loop anastamosis is completed. The lower limb of the bowel that carries only bile, and not any food, is then reattached a foot or so further downstream. The theoretical benefit of this extra step is to keep bile from refluxing up into the esophagus and causing irritation or damage. The potential risks of this extra step are having a second anastamosis at which a leak can occur and an increased risk of bowel obstruction after the operation.

Potential Surgical Risks for the Sleeve-Gastric Bypass (SGB) & Roux en Y (RNY) Short-Term Risks: Any surgical procedure has risks of bleeding and infection. The most feared complication from a stapling weightloss surgery is a leak where the long, narrow stomach pouch connects to the small intestine. A leak can be a lifethreatening problem. The SGB/RNY procedure performed at Regional Bariatrics has an extremely low leak rate, less than one percent of all the patients who have had surgery. Diagnosing and treating a leak quickly is important to ensure an excellent outcome. For this reason, our surgeons do not order a host of lab work and tests when a leak is suspected. Rather, patients exhibiting an unusual amount of postoperative pain are taken back to the operating room for a laparoscopic exam. This process allows a definitive diagnosis to be made along with the opportunity to appropriately intervene and fix the problem. Respiratory complications are best avoided by early activity. Nurses ambulate (walk) patients as quickly as possible the day of surgery to best prevent blood clots from forming in the legs (deep vein thrombosis or DVT) that could ultimately break off and go to the lungs (pulmonary embolus or PE). Compression hose devices that provide pneumatic compression on the legs are also utilized to lessen DVT risk. Patients are expected to stop smoking at least two weeks prior to surgery. Complying with this recommendation is essential to decreasing the risk of serious lung complications developing after surgery. At High Point Regional Health System (HPRHS), there are board certified pulmonary specialists available at all times for any potential problems. Cardiac complications are rare; however, HPRHS is the home of the Carolina Regional Heart Center, a Center of Excellence for diseases of the heart. Cardiac specialists are also available at all times for any problem that might occur. The mortality or death rate at HPRHS for the SGB/RNY is very low, only 0.12% (one patient) has died due to a complication with the procedure.

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Long-Term Risks: Anastomotic ulcers at the connection of the long, narrow pouch with the intestines is a serious potential problem. Although anyone can develop a stomach ulcer, SGB/RNY patients are particularly susceptible. Patients who smoke, drink alcohol, use aspirin products or nonsteroidal anti-inflammatory drugs (NSAIDS) can develop ulcers. Additionally, infection with bacteria called H. Pylori can often contribute to the development of stomach ulcers. Most of these offending agents either cause increased acid secretion or decrease the stomach’s protective coating. Patients often detect a “gnawing,” burning or nauseous sensation when stomach irritation is developing. If H. Pylori is suspected, patients are typically treated with a combination of medications to decrease acid in the stomach along with antibiotics to eliminate the H. Pylori bacteria. Yogurt with live cultures is recommended to promote normal “healthy” bacteria in the stomach. Pepto-Bismol is used to protectively coat the stomach. Longterm ulceration may cause scarring and narrowing at the anastomosis (or connection of the long, narrow pouch and the intestine). Such a stricture can often be treated with a procedure called an upper endoscopy (EGD) with a balloon dilatation. Some popular antidepressants, called selective serotonin reuptake inhibitors (Paxil, Prozac), have been shown to increase the risk of upper gastrointestinal bleeding. Before starting any medication, you should carefully review its possible side effects with your surgeon and avoid those that may be harmful to the stomach. Some patients have gastro esophageal reflux disease (GERD). GERD results when stomach acids repeatedly splash into the esophagus, causing damage. Many patients (67 percent) find their GERD ceases or greatly improves after SGB/RNY; however, a minority of patients develop GERD as a side effect from surgery. Most of these patients are easily treated with one of the excellent antacid medications that are available today. Irritation of the esophagus can also come from exposure to bile produced by the liver, or bile esophagitis. The long, narrow stomach pouch is designed to provide a buffer zone to keep bile from reaching the esophagus. As a result, the incidence of bile reflux is extremely low in SGB/RNY patients (less than one percent). Nonetheless, patients should always report heartburn-type pain of any kind to their surgeon. The bypass portion of the SGB/RNY results in malabsorption of calories as well as many beneficial vitamins, proteins and other nutritional building blocks. Most patients avoid nutritional deficiencies simply by eating a well-balanced, healthy diet coupled with three multivitamins daily. Some patients will require additional supplements, depending on their individual needs. Vitamin B-12, folate and iron are a few of the levels to be monitored closely with lab work after surgery. It is recommended to have these levels, along with others, checked annually. (Refer to Appendix 2 for complete list) Zinc deficiency may occur. Meat and poultry are the main sources of zinc in the American diet. General signs of a low zinc level can be poor appetite, fatigue and most noticeably, hair thinning. Treatment with zinc sulfate 200mg three times daily is usually a very effective treatment. Zinc-containing shampoos can also be used. Osteoporosis is a concern for many patients and certainly for SGB/RNY patients. Gastric Bypass surgery and weight loss in morbidly obese patients can cause increased bone resorption and bone loss. Careful monitoring of calcium and vitamin D intake at recommended dosages is essential for optimal bone health. Metabolic bone disease is a serious potential problem following SGB/RNY. Chronic vitamin D deficiency, inadequate calcium intake and elevated parathyroid hormone are common among obese individuals, placing them at risk for low bone mass prior to surgery. Following surgery, these risks, coupled with significant weight loss, decreased oral intake and bypassing the major site of the intestine for calcium absorption, places patients at even more risk. Careful monitoring of vitamin D levels, urine calcium, protein levels, vitamin B-12 and magnesium is essential to early detection of metabolic bone disease. It is recommended that all patients get a Bone Density Scan (DEXA Scan) prior to surgery as part of the preoperative evaluation screening and again two 7


years after surgery to re-evaluate. Treatment for osteoporosis could include supplementation with Calcium 1200 mg/day and Vitamin D 800 IU/day. Standard supplementation for patients includes a multivitamin with minerals three times a day; calcium and a diet containing 1.0 to 1.5 grams of protein/kg per day. Any deficiencies reflected in lab work should be corrected immediately. Decreased iron absorption, as well as low levels of vitamin A, can result in iron deficiency anemia. This anemia results in low red blood cell counts and can lead to fatigue and weakness, as well as problems with the immune system. Iron deficiency can develop in SGB/RNY patients, particularly women who are still menstruating. Iron levels and any other related blood levels are checked each year after the SGB/RNY to ensure no deficiencies develop. Even following the guidelines for a healthy diet with supplements, a few SGB/RNY patients may experience excessive weight loss and get too thin. If appropriate supplementation cannot reverse the problem, the bypass portion of the SGB/RNY can be reversed or revised to allow improved absorption of calories. Excessive weight loss is rare, occurring in less than one percent of patients. A small number of patients experience insufficient weight loss and don’t reach goal weight. It is very important to discuss a goal weight with your surgeon. If patients do not reach goal weight within two years of the original SGB/RNY surgery, a “revision” surgery may be required. This surgery consists of moving the bypass “further downstream,” possibly from a six-ft bypass to a 12-ft bypass. All morbidly obese patients have some degree of fatty deposits or fatty liver disease within their livers. The amount of deposits can range from mild to bordering on severe or cirrhotic-type changes. The majority of these changes will improve or resolve as a result of weight loss. While these changes are taking effect, it is possible to have a worsening of one’s liver function. For this reason, the recommendation is to avoid items that can be damaging to the liver, such as alcohol and acetaminophen (Tylenol). When any new medication is prescribed, ensure the prescribing doctor checks the effect this medication could have on the liver and new, smaller stomach. Patients undergoing rapid weight changes are also at high risk for developing gallstones. A medication called Actigall is prescribed as a sort of bile “antifreeze” to keep patients from forming gallstones. The dose is 300mg twice daily and always should be taken with food. This routine begins two weeks after surgery and continues as long as weight loss is rapid (10 or more pounds per month). Even patients without a gallbladder may benefit from Actigall as it is possible to form stones within the bile ducts themselves. Some patients have significant abdominal pain when taking Actigall and may need to discontinue its use after discussion with the surgical team. Any abdominal operation can produce internal scar tissue, resulting in a bowel obstruction, both short term as well as long term. The SGB/RNY procedure has had a less than one percent incidence of bowel obstruction. Any procedure producing malabsorption can result in diarrhea. Most SGB/RNY patients can manage this issue with fiber supplements. The recommendation is to consume one teaspoon of Citrucel dissolved in three ounces of liquid twice daily beginning discharge day from the hospital and continuing for life. A hernia, or hole in the muscular layer of the abdomen, is very rare and seen in less than one percent of patients. Pregnancy after SGB/RNY is often successful, with those patients having healthy babies. However, it is strongly recommended that women abstain from becoming pregnant for at least the first year after the SGB/RNY as their bodies are undergoing a dramatic change and may not achieve adequate weight loss. In addition, hormone- based contraceptives will likely not effectively prevent pregnancy after the SGB/RNY. Due to changes in estrogen levels, fertility may be increased. Please coordinate increased contraceptive needs or pregnancy plans with obstetrics/gynecology.

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Potential Weight-Loss Results for the SGB/RNY: (Refer to Appendix #1) The typical weight loss for an average 300-pound patient who undergoes a six-foot bypass after the SGB/RNY is 120 to 140 pounds at the one-year mark. Patients over 300 pounds who have received the SGB/RNY at Regional Bariatrics over the past five years are demonstrating excellent results when evaluating the improvement or elimination of many weight-related illnesses. The average patient in this program loses 70 percent of their excess body weight by two years postoperatively. In addition, most patients report improvement or resolution of high blood pressure, diabetes, high cholesterol, shortness of breath, sleep apnea, joint problems and headaches.

An Overview of the Sleeve Gastrectomy Sleeve gastrectomy is a form of surgical weight loss. During this weight-loss procedure, the stomach is reduced in size by 85%. The remainder of the stomach is removed. This form of weight-loss surgery is preformed using laparoscopic surgery and is not reversible. The term “sleeve� refers to the new look of the stomach pouch. The new pouch/sleeve is shaped like a banana or sleeve of a long-sleeved shirt.

Short-term risks

Leaks or bleeding may occur along the stomach stapling edge. All surgery and anesthesia involves some level of risk including bleeding, blood clots, infection, pneumonia or complications. Respiratory complications are best avoided by early activity. We expect patients to ambulate (walk) as quickly as possible the day of surgery to best prevent blood clots from forming in the legs (deep vein thrombosis or DVT) that could ultimately break off and go to the lungs (pulmonary embolus or PE). Compression hose devices that provide pneumatic compression on the legs and blood-thinning medications may also be utilized to lessen DVT risk. Patients are expected to stop smoking at least two weeks prior to surgery.

Long-term risks

With time, the new smaller stomach pouch may stretch (also occurs with gastric bypass surgery). The surgery is not reversible as a portion of the stomach is permanently removed. Although the gastric sleeve helps control hunger and limit amount of food that can be eaten at any one time, weight loss will not occur without a healthy, low-calorie diet and regular exercise. A second malabsorptive weight-loss surgery, such as a bypass, may need to be preformed at a later time.

Advantages of Gastric Sleeve Weight-Loss Surgery

*Promotes weight loss by restricting the amount of food that can be eaten at any one time *Reduces hunger since it removes the part of the stomach that produces the hunger-stimulation hormone ghrelin. *Digestion occurs normally as the digestive system is not altered. *Does not cause malabsorption or nutritional deficiencies as it does not involve rerouting or bypassing the small intestine. *Does not cause severe malabsorption or nutritional deficiencies as it does not involve rerouting or bypassing the small intestine.

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An Overview of the Adjustable Gastric Banding (AGB) The laparoscopic Adjustable Gastric Banding (AGB) procedure is a specific type of weight-loss surgery. During gastric banding surgery, a band is wrapped around the upper stomach to limit food intake and slow the progress of food through the digestive system. No part of the stomach is stapled or removed. The intestines are not rerouted, the small intestine can absorb nutrients from food and waste can be eliminated in the normal manner. There are currently two types of Adjustable Gastric Bands (AGB), the REALIZETM Band www.Realize.com and the LAP-BANDŽ www.LapBand.com. Both are FDA approved. The AGB procedure consists of the implantation of two medical devices. The first implant, the band, is wrapped completely around the upper part of the stomach. The second implant, the injection port, is attached to the abdominal wall underneath the skin. The injection port is used to add saline (salt water) to the band during adjustments after surgery. The two implants are connected by a soft, thin, hollow tubing. The AGB is implanted using laparoscopic surgery through several small incisions similar to the SGB procedure. A small laparoscopic camera is placed through one of the incisions and into the abdomen, allowing the surgeon to see while placing the band around the stomach. Next, tubing is connected to the port and the port is fastened to the abdominal wall underneath layers of skin and tissue. The port is usually fastened (or sutured) on the left or right side, about two inches below the rib cage. The exact location depends upon each person’s body shape and the surgeon’s judgement. All incisions are closed with stitches. The band portion of the AGB is a strong, flexible silicone structure that fits securely around the upper stomach. The inside of the band has a soft balloon that comes in direct contact with the stomach. The balloon can be filled with saline and the amount of saline controls tightness (restriction) around the stomach. In turn, the amount of restriction affects how much food can be eaten during a meal and the length of time it takes food to progress through the digestive system. This allows patients to feel full sooner and stay full longer. The injection port is made from medical plastic. There is a strong layer on the top. During band adjustments or tightening of the band, saline is injected with a needle into the port through this layer. This tightening creates restriction and reduces the desire to eat as much food. The port is fastened to the abdominal wall underneath layers of skin and tissue. The port is completely enclosed inside the body. Patients may be able to feel the port by gently pressing on the abdomen; otherwise patients are usually not aware of its presence. Potential Surgical Risks for the Adjustable Gastric Band (AGB) There are risks associated with gastric banding surgery. Some are associated with abdominal surgery, some are specific to a gastric band and some may be unique to individual patients. Weight, age and medical history play a significant role in determining specific risks. If there are any health conditions -- such as heart disease or diabetes or conditions requiring medications such as blood thinners, or previous surgeries -- our surgeons will inform patients about specific risks for gastric banding surgery. Short-term Risks: Some risks are associated with any adjustable gastric band, and complications can occur after the surgery is completed. Some of the potential complications are more serious and may require a re-operation. Migration of the implant, which includes band erosion, band slippage and port displacement, can occur. Additionally, there can be tubing-related complications such as port disconnection and tubing kinking. A band leak can develop, causing some of the saline in the tubing to escape and an infection to develop. Infection can also develop near the injection port location. Some patients may experience an 10


obstruction of the opening between the pouch above the band and the lower stomach. This problem can occur if patients fail to chew food thoroughly or begin eating the wrong types of foods too soon after surgery. Side Effects and Discomfort: After surgery, patients will need to adjust to the newly implanted band. Recovery experience may vary from patient to patient. Regurgitation, nausea, acid reflux, constipation and diarrhea are typical, but abdominal pain that lasts more than three hours means there is a more serious problem and patients must contact their surgeon.

Potential Weight-loss Results for the AGB: (Refer to Appendix #1) The FDA approved the REALIZE Band for use in the United States based upon results from a three-year clinical study. The study began with 276 patients; 228 completed the study. Results show that 224 patients lost an average of 40% of their excess weight at one year. By the end of the second year, 212 patients lost 45% of their excess weight. By the end of the study, the majority of the patients had maintained their percent of excess weight loss (%EWL). Additionally, patients were able to reduce their average BMI from 44 to 36 in the first year after surgery. Patients were able to maintain their reduced BMI through their third year. Potential Surgical Risks with any Abdominal Surgery There are potential risks associated with any abdominal surgery. These risks are greater for individuals who suffer from obesity. Laparoscopic surgery reduces some of these risks compared to open surgery, but laparoscopic surgery is not appropriate for some people. The decision to perform open surgery is a judgment made by your surgeon either before or during the actual operation. The decision is based on patient safety. Risks associated with any general abdominal surgery include bleeding, pneumonia, complications due to anesthesia and medications, deep-vein thrombosis or DVT (blood clot to the leg), injury to the stomach, esophagus or surrounding organs, infection, pulmonary embolism or PE (blood clot to the lung), stroke, heart attack and death.

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PATIENT-SELECTION GUIDELINES Patient-selection guidelines are designed to ensure that only patients who are most likely to benefit from weightloss surgery will have a procedure. Each application packet is reviewed on an individual basis; the surgeons at Regional Bariatrics are happy to discuss any special circumstances regarding individual health history. In general, patients over 450 pounds or with a body mass index (BMI) greater than 60 have a higher surgical risk because the procedure becomes technically more challenging. Patients with a history of previous upper abdominal surgery often have internal adhesions or scar tissue that may lengthen the time it takes to perform the operation. For this reason, plans may be altered during the actual surgical procedure. Additionally, patients who have had stomach or spleen surgery may not be offered weight-loss surgery. However, circumstances will be reviewed with patients and their physicians on a case-by-case basis, allowing for any questions or concerns to be answered and addressed. Patients who exceed 450 pounds or have a BMI greater than 60 are placed into a physician-supervised, rapid weight-loss program to ensure they can achieve the necessary weight goal to better undergo a safer weight-loss surgical procedure. Patients must be between the ages of 18 and 64 years of age. Due to government restrictions from Medicare, anyone 65 years or older will not be approved for surgery. Weight-loss surgery for teenagers, however, may be considered but only after extensive dialogue with the patient’s parents, pediatrician and psychologist prior to considering a surgical option. Not all patients are candidates for weight-loss surgery. Patients seeking surgery at Regional Bariatrics ideally should meet the following guidelines: • • • •

Medical Feasibility: Evaluated through our Preoperative Screening Information. Patients must complete the online patient information form located at www.regionalbariatrics.com. Age: Patients must be between the ages of 18 and 64 years of age. (Younger patients must be very well motivated, informed and have strong family and physician support to be considered for surgery). BMI: Patients must have a BMI of 40 kg/m2 or above, or a BMI of 35 to 40 kg/m2 with co-morbidities (Patients usually qualify based on weight if ideal body weight is 100 pounds above normal) Weight: A patient’s body weight must not be greater than 450 pounds. Our Center offers a non-surgical, pre-operative weight-loss plan for any patient who exceeds this limit and desires weight-loss surgery. (Each patient is evaluated on an individual basis to ensure a safe outcome after weight-loss surgery.) Employment status: Patients who are disabled or wheelchair bound may not be good candidates for surgery. For this reason, candidates must presently be working, either in or out of the home. (Candidates who are students or housewives can meet these guidelines if they are mobile and able to demonstrate activity.) Financial Viability: Regional Bariatrics accepts most insurance plans. Our team will work with you to ensure you have appropriate financial resources to adequately cover the associated surgical and nonsurgical expenses associated with your procedure. Communication Access: Patients must have a reliable e-mail address that can accept "attachments” Note: It is important that work email addresses are not utilized as patients receive a high volume of emails that are confidential in nature.

Patients with the following history will not be considered good candidates for surgery: o

Surgical History

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History of previous weight-loss surgery such as vertical banded gastroplasty, “stomach stapling,” Roux-en-Y Gastric Bypass or other types of weight-loss surgeries  History of major abdominal surgery (Some operations such as an appendectomy, gallbladder removal or hysterectomy may be acceptable.) Psychological History  History of alcohol abuse or drug use  History of major psychiatric illness  History of depression; patients and his/her psychiatrist must have a pre-operative plan to manage this depression post operatively Medical History  Recent Prednisone Therapy for any reason  Systemic Lupus Erythematosis (SLE)  Rheumatoid Arthritis  Other Collagen Vascular disease 

o

o

Patients with the following will be considered good candidates for surgery: o Documentation demonstrating a strong, supportive and stable family structure with immediate family support for the patient’s desire to have weight-loss surgery o Documentation demonstrating a supportive personal physician (family practice or internal medicine) including:  Support of the patient’s desire to have weight-loss surgery  Completion of a detailed and meticulous preoperative evaluation  Agreement to actively be involved in the postoperative follow-up care with our team o Documentation committing to participation in a postoperative exercise program o Commitment evidenced by the willingness to work with staff by following directions and communicating in a timely manner o Commitment to communicate with staff during the postoperative period in the event of a problem or complication o Commitment to follow up postoperatively, as recommended, to decrease the risks of complications such as ulcers, vitamin, mineral and other nutritional deficiencies 

SGB/RNY Follow-Up: • 1 month, 6 months, 12 months and annually thereafter at the Center • Lab work as recommended (Refer to Appendix #3)

SGB/RNY/SG Follow-Up: • 1 month, 6 months, 12 months and annually thereafter at the Center • Lab work as recommended (Refer to Appendix #3)

AGB Follow Up: • 1 month, monthly for 6-8 months after placement, 12 months, probably 3-4 times per year for 3 years, then annually thereafter. • Adjustments: First adjustment 5-6 weeks after surgery and every 4-6 weeks thereafter as needed. Expect 6-12 adjustments in first two years. Check with your insurance company for their policy for covering fills after placement of AGB.

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PATIENT PATHWAY TO SURGERY

How do I get started? (Refer to Appendix #2) Patients desiring weight-loss surgery will need to determine which weight-loss procedure they want. An Application Packet must also be completed. This packet contains various medical evaluations and extensive patient “homework.” Completion of this homework gives an opportunity for patients to demonstrate understanding of the available weight-loss procedures, any associated risks and the required lifestyle changes necessary to maintain a healthy postoperative life. Completion of the Application Packet is time consuming and often described as difficult. However, it is designed to help answer all questions. The staff at Regional Bariatrics will review the packet to ensure clear understanding is evident. As part of the completion of this packet, you will be asked to complete the following steps: 

Attend a Patient Information Seminar: Patients are required to attend a free patient information seminar. These seminars are 90-minute informational sessions given by the surgeons and our program staff. Patients must attend the seminar prior to scheduling an initial consultation with the surgeon. However, exceptions can be made for patients living more than 100 miles from the clinic. Seminars are held at our office located at 710 North Elm Street in High Point, NC. Register for a seminar by calling our office at (877) 878-7644 or registering online at our website.

 Visit our website: www.regionalbariatrics.com This website contains important information about weight-loss procedures offered at Regional Bariatrics, as well as news and updates regarding our program.  Send in your Application Packet information: Submission of this information can be completed online via our website or delivered to our office in hard-copy form. o Provide front- and side-view photographs of you in a bathing suit or tight-fitting clothes to help our surgeons assess the shape of your abdominal cavity. Do not include nude photos.  Obtain a letter from your regular medical doctor: This letter must contain an assessment of your weight problem and its impact on your health. It must detail previous nonsurgical efforts at weight loss. It must state that you are in an acceptable overall medical condition to undergo surgery. It must also state your doctor’s support for your decision for weight-loss surgery, as well as a willingness to continue to follow you postoperatively. A close relationship with your primary medical doctor is essential to your long-term success as a weight-loss surgery patient.  Complete or obtain copies of medical information from your regular medical doctor including: o Labs – CBC, CMP, Vitamin D, TSH o EKG – need copy of the tracing o Chest X-ray (if you are or have been a smoker or have had any other lung problems) o Exam or progress notes from your appointment – should have history and physical with allergies, list of medications, etc. o Clearance / Reports from any specialists that you see (cardiologists, pulmonologists, etc.) o Pulmonology evaluation and clearance for surgery if you have Sleep Apnea  Complete psychological evaluation: A formal evaluation by a psychologist or psychiatrist prior to surgery is required. Rarely this evaluation will reveal problems that would contraindicate surgery. The most important reason for this assessment is to provide a resource for any postoperative stress or depression. Some patients will have significant mood swings after surgery; therefore, having a support mechanism in place is essential.

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 Obtain family-support letter: It is critical that not only you, but also your family, fully understands the risks and expectations of surgery. A letter from your spouse, child, parents or friend expressing their understanding of the procedure as well as their support for your decision is required. This letter must be notarized. Your support person must also accompany you to the preoperative education class and be available the day of the operation and during your surgical recovery.  Complete education: Read this education manual fully. You must also document contact with at least 10 weight-loss surgery patients. This contact can be completed online or in person at various support group meetings or clinics. Contact our office for a list of volunteer patient contacts. Feel free to ask these patients any questions regarding weight-loss surgery or their new lifestyle. This is a unique opportunity to interact with patients who have already been through the process. Finally, you must attend a pre-operative educational class. This group class will be taught by our bariatric staff and will outline the bariatric surgery procedures, provide nutritional and dietary guidance, outline behavioral modifications necessary to maximize your weight-loss results and answer any questions you may have about the day of surgery and your ongoing follow-up. Your significant other must attend this class with you.  Complete patient letter: This letter will be the biggest project in your “homework” list. The letter is to be typed in standard 12-point font and address each of the subjects below. Each topic should receive from one-half to a full page of content: o Health risks of obesity o How is the weight-loss procedure you have selected performed? o Short-term risks o Long-term risks o Lifestyle changes o Expectations after surgery o Need for long-term follow-up o Alternatives to surgery o Different types of surgery

What process will I follow after I am approved for surgery?  One Month Prior to Surgery o Stop Smoking! Clinical studies have shown that smoking cessation at least two weeks prior to surgery significantly reduces risks of serious lung problems after surgery. Your primary medical doctor will be happy to start you on a nicotine patch or other program to help with your transition to a healthy lifestyle.  Two Weeks Prior to Surgery o Stop taking Aspirin and NSAIDS (Motrin, Advil, and many other arthritis medicines). These medicines can cause serious problems for the stomach. o Stop taking any blood thinners. Aspirin, Coumadin, and Plavix are some popular blood thinners that can cause bleeding difficulties with your surgery. These medicines should be stopped only after careful review with your primary medical doctor and surgeon. Avoid 15


excessive Vitamin E supplements as these may also cause bleeding difficulties. The small amount in a daily vitamin is permitted. o Discuss any other prescription medicines or herbal supplements with the surgical team. o Give up caffeine. Coffee, tea and sodas are not recommended after weight-loss surgery … ever. Weaning from caffeine prior to surgery will avoid the issue of having an unpleasant caffeine withdrawal after surgery. o Make plans to stay within one hour’s drive of the hospital for the first week after surgery. Ask our administrative staff for details on special discounts at many of the neighboring hotels. You must have your support person with you the day before surgery, the day of surgery, as well as the first week after surgery. o Remember to bring any medical equipment, including a blood pressure cuff, diabetes testing device and sleep apnea equipment.  The Day Before Surgery o Shave any facial hair. Beards and mustaches can interfere with the anesthesia mask used and add an unnecessary risk. o Eat a light dinner. Do not treat this as your last “normal” meal, as the food overload and gas will make your operation much more technically challenging. o Do not eat or drink after midnight! This includes gum. o Hibiclens (chlorhexidine) shower the night before surgery as well as the morning of surgery. This antibacterial shower helps lower infection rates. Use this as a soap but NOT as shampoo, as exposure to your eyes and ears can be harmful. o Take the following medications (for AGB ONLY): 

Milk of Magnesia. This laxative is taken the morning of the day before your surgery, NOT the morning of your surgery. Take 60mls (4 tablespoons). This medication cleans out your digestive tract.

Prilosec OTC (omeprazole): Take one 20mg tablet the night before surgery (9pm to 11pm). This medication lowers stomach acid and makes your anesthesia and operation safer. Nexium, Aciphex and Prevacid are all acceptable substitutes.

o Take the following medications (for SGB/RNY/SG ONLY): •

Milk of Magnesia. This laxative is taken the morning of the day before your surgery, NOT the morning of your surgery. Take 60mls (4 tablespoons). This medication cleans out your digestive tract.

Prilosec OTC (omeprazole): Take one 20mg tablet the night before surgery (9pm to 11pm). This medication lowers stomach acid and makes your anesthesia and operation safer. Nexium, Aciphex and Prevacid are all acceptable substitutes.

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Levofloxacin: Take 500mg the night before surgery (9pm to 11pm).

What process will I follow the day of surgery?  The Morning of Surgery o Take the following medications (for SGB/RNY/SG ONLY – no medications for AGB): •

Prilosec OTC: Take one 20mg tablet the morning of surgery (5am). This medication lowers stomach acid and makes your anesthesia and operation safer. Nexium, Aciphex and Prevacid are all acceptable substitutes.

Reglan (Metoclopramide): Take 10mg early the morning of surgery (5am). This medication empties the stomach and helps protect against pneumonia. Take with a sip of water.

o Do not wear makeup or jewelry. o Arrive at the time specified by our surgical team. Once checked in at the hospital you will have an IV started and then taken to the operating area with the anesthesia team. Your operation will likely take about one hour. Your surgeon will visit with your family after you are safely in the recovery room. o Bring any special items you may need. This would include any BIPAP or CPAP equipment you may regularly use for sleep apnea.

What process will I follow after surgery? Hospital Stay: o Your hospital stay will likely be only overnight. o

Nurses will make sure you get up and walk regularly to prevent blood clots. They have plenty of medications to help with pain or nausea.

o Nurses will monitor your blood pressure, vital signs and blood sugar frequently. Your surgeon will be notified if any of these values appear abnormal. o Nurses will assess your pain level frequently. You can expect to have mild pain (about a level of 4 out of 10 on the pain scale) the morning after surgery. Excess pain accompanied by an elevated heart rate alerts your nurses and surgeon of the potential of a leak. Although this complication is very rare, your surgeon will want to return to the operating room to examine the inside of your abdomen. o Nurses will check for nausea the morning after your surgery. Nausea is not uncommon but should resolve before discharge home. Patients who experience more nausea than normal may receive a “bariatric cocktail” that is a combination of several medications designed to reduce swelling and alleviate the nausea.

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o Nurses will encourage you to walk frequently to help prevent blood clots in the legs. o Nurses will assess your surgical sites and bandages frequently. While serious bleeding is very rare, oozing from your surgical port sites is common. Expect to have blood on the bandages. Oozing prevents extra drainage from collecting within the abdomen and producing a painful hematoma (blood collection). Many patients will have a small drain left in to remove any internal oozing. This drain will appear to drain a lot of blood-tinged fluid; however, most of this is clear healing fluid that is colored red by a little blood. This drain is typically removed the morning after surgery. o Nurses will prepare you to be discharged home the day after surgery. Generally, patients go home by mid-day the day after surgery.

What process will I follow when I go home? What to Expect Upon Leaving the Hospital o Activity: • You should be alert and able to perform your normal daily activities at home, barring any significantly stressful exercise. • Walking, including stairs, is essential. • No driving until you are back to normal and able to operate your vehicle without pain or distraction. This usually takes 1-2 weeks’ time. • Expect to get tired easily the first few days after surgery. Often, this is a sign that you need extra sodium. Eat something salty. o When to notify your surgeon: • You should not have high fevers, shortness of breath or a rapid heart rate. • Temperature of 101.5 • Pulse (after a 10-minute rest) that is greater than 100 beats per minute. (Take your pulse several times daily. A rapid pulse is often the first sign of an important problem.) • Sustained pulse of 120 beats per minute during the first 30 days postoperatively. • Uncontrollable vomiting or abdominal pain. (You should expect minimal nausea if you don’t overload your new stomach pouch. Eat slowly.) • If you are not feeling well or concerned about your condition, call your surgeon immediately! Our surgical team is available no matter when you need them. Contact the answering service at 1-(866) 573-6321 and ask for the person on call for Dr. Dasher or Dr. Walsh. Leave your name and phone number and the on-call person will call you back. o General instructions: • No smoking. Smoking is particularly damaging after weight-loss surgery. Your surgeon can assist you with smoking cessation which should ideally occur at least one month prior to surgery. • Diarrhea can occur following surgery and usually resolves on its own after 10 days as your body adjusts to the new bypass. Constipation may also occur and can be treated with a small dose of Milk of Magnesia.

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• • •

You may shower the day after surgery and leave the incisions uncovered. No tub soaking. You should expect some clear or bloody discharge from your incisions and may cover them with gauze or bandages, if needed. Vaginal yeast infections are a common problem for many women, especially following antibiotic treatment. Symptoms may include burning, itching and a white discharge. Any of the over-thecounter medications, such as Monistat, are appropriate to use. Fungal infection of the mouth -- called thrush -- may occur after antibiotic treatment. Thrush usually presents with painful swallowing and white patches in the mouth/tongue. Thrush is treated with an oral rinse called Nystatin.

For Sleeve-Gastric Bypass/Roux en Y Gastric Bypass/Sleeve Gastrectomy Patients • You will begin Stage 1 diet. This consists mostly of Gatorade©, vegetable juice and thin soups. Very sweet juices may need to be diluted with water to avoid abdominal cramping and the dumping syndrome. G2 -- a low-sugar alternative to Gatorade -- is another good option. It is important that you constantly are “sipping” to get the appropriate amount.  Drink three to four 20-ounce bottles in 24 hours. Do not overload your new stomach pouch! Eat no more than two to three tablespoons at one time. Wait at least 15 minutes before eating anymore. This prevents too much pressure on your pouch.  Eat nonfat yogurt with live cultures at least once daily to promote “good” bacteria in your new intestinal hookup.  Saltine crackers and Pringles low-fat chips are also good snacks.

For Adjustable Gastric Banding Patients…  You will begin Stage 1 diet for the first two weeks. This consists mostly of Gatorade, vegetable juice and thin soups such as broth or bouillon.

o Required Discharge Medications (for AGB patients ONLY): Begin upon discharge from the hospital: • Multivitamins: Do not start until two weeks after surgery! Take one daily. Your choice should include iron as one of the ingredients. We recommend “Wal-Mart One Source” vitamins. Multi vitamins with minerals are continued for life! If nausea seems to occur with usage, stop the vitamins for two days and then restart taking one with each meal. • Reglan (Metoclopramide): 10mg to be used only if having nausea; you may take one up to three times a day. • Phenergan (Promethazine): 25mg-50mg, one every four to six hours as needed for nausea or vomiting. This medication is stronger than Reglan. Both may cause drowsiness. • Calcium Citrate and Vitamin D: Take one daily. o Required Discharge Medications (for SGB/RNY/SG patients ONLY): Begin upon discharge from the hospital: • Prilosec OTC: 20mg twice daily for four months. This medication keeps acid production low in your new stomach. • Bismuth Subsalicylate (Pepto-Bismol): Take one tablespoon every six hours for six months following surgery. This medication coats and protects your new stomach. • Citrucel fiber: Take one teaspoon mixed in three ounces of liquid twice daily. This medication will continue for life! It promotes intestinal health, regularity and aids in weight loss. • Calcium Carbonate (TUMS): Take two tablets three times daily. This supplement helps neutralize stomach acid and is also a good source of calcium. Continue calcium for at least two months and consider continuing TUMS as your daily calcium supplement forever. 19


• •

Ursodiol (Actigall): Do not start until two weeks after surgery. This medication helps reduce the risk of gallstones. Take 300mg twice daily and ALWAYS with food. You should continue Actigall as long as you are losing more than ten pounds per month, typically three to six months. Multivitamins: Do not start until two weeks after surgery! Take one three times per day. Your choice should include iron as one of the ingredients. We recommend “Wal-Mart One Source” vitamins. Multi vitamins with minerals are continued for life! If nausea seems to occur with usage, stop the vitamins for two days and then restart taking one with each meal. Vitamin D3 2000 units: Take 2000 units of Vitamin D3 daily.

What to Expect the First Week after Surgery o The first week after surgery requires daily phone contact, including weekends. • Call the Bariatric Center at (336) 878-6340 between 8am and 5pm Monday through Thursday or between 8am and 12noon on Friday if you have any clinical questions and for routine check-ins daily. For routine check-ins, leave a voicemail. Adjustable Band patients do not need to call unless there is a problem. • It is important that you call every day from the day after discharge from the hospital until the time you are seen at the Regional Center for your first post-operative visit. • If after-hours or you are in pain, have a sustained heart rate of 120 beats per minute or faster, or uncontrollable vomiting, contact the answering service at 1-(866) 573-6321 and ask for the person on call for Dr. Dasher or Dr. Walsh. Leave your name and phone number and the on-call person will call you back. Our surgery call team consists of a board-certified surgeon, a physician assistant and a nurse at all times. If you have a problem, there is NEVER a time when you cannot reach a member of our surgical team. If you need assistance and your first call is not answered within 10 minutes, call again as occasionally electronic pages don’t go through.

What diet will I follow? Weight-loss Surgery Diet Basics – All Stages o Follow the diet texture guidelines closely for best results and least chance of complications. o Everyone is different and may not progress at the same rate. o Avoid fresh white bread, pasta, rice and dry red meat. o Chew slowly and thoroughly. The stomach can hold only two to three tablespoons after surgery. Be sure to measure your food. o Pay close attention to your body’s sensations before, during and after meals. Stop eating at the earliest sign of fullness or discomfort.

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o Avoid concentrated sugars or fats. They can cause “dumping syndrome” for SGB/RNY patients and can lead to slower weight loss. o Drink at least 48-72 ounces of fluid per day to prevent dehydration and constipation.  Liquids should have no calories.  Take frequent sips and do not use a straw as they can cause you to swallow air, which can lead to gas.  Carry a bottle for your liquids to help you track how many ounces you are drinking per day.  By Stage 3, stop drinking 15-30 minutes before meals and wait 15-30 minutes after meals to begin drinking again.  Do not drink carbonated drinks as they can cause gas and bloating.  Do not drink coffee or caffeinated drinks as they may cause ulcers or dehydration and stimulate the bowel, causing cramps and diarrhea. o Start each meal with a protein source. o Eat small high-protein low-fat meals throughout the day. Early meals will be mostly protein. Gradually add unsweetened canned fruits (no skins), soft cooked vegetables (no skins), then whole grains and firmer proteins. o If you cannot tolerate dairy, try using Lactaid milk. You may also try Lactase or Dairy Ease to help digest the lactose. Soymilk is also a good option. o Be consistent about taking your multivitamins and medications. If you are asked to take an additional iron supplement, do not take your calcium and iron at the same time. This decreases the absorption of both. o Nonfat dry milk powder or plain whey protein can be added to soups, cooked cereals and sugarfree puddings to increase protein content. o Unjury protein drink, sugar-free Slim-fast, low-carb Carnation Instant Breakfast, Carb Solutions and Resource Optisource are examples of acceptable protein shakes. Weight-loss Surgery Diet for the Adjustable Gastric Band Only o For the first two weeks after surgery, you will be on a Stage I diet (below). This consists mostly of Gatorade, vegetable juice and thin soups such a broth or bouillon. o During the second week, you can add Boost, Ensure or any Protein shake to the above diet. o Following the second week after surgery, you can have pureed foods for two to three days. These foods are baby-food consistency such as mashed potatoes watered down. All foods must be of the consistency of thinned mashed potatoes and fit through a strainer. o Following pureed foods, you may start soft “mushy food” such as mashed potatoes, applesauce and oatmeal for one week. o During the fourth to fifth week you can start eating regular foods. You should eat between six and eight small meals per day. All foods must be chewed thoroughly before swallowing. Stage I (SGB/RNY/SG and AGB) 21


This stage continues for at least two weeks following surgery. Hydration is the priority. This stage consists mostly of Gatorade®, fruit and vegetable juices and thin soups. Very sweet juices may need to be diluted with water to avoid abdominal cramping and the dumping syndrome. Water cannot be the main liquid you ingest. Gatorade and other sports drinks contain the electrolytes you need. o Food Examples: • Gatorade or 62 • Broth, bouillon, consume • V-8 Juice, Tomato juice • Strained chicken noodle soup • Sugar-free flavored gelatin • Sugar-free popsicles, sugar-free sorbet • Non-caloric flavored waters (Crystal Light, Kool-Aid, Wyler’s Light, Fruit 2.0, etc) • Saltine crackers chewed to liquid consistency • Smooth yogurt: sugar-free/low-fat • AVOID coffee, teas, sodas, cream soups, commercial supplements, straws Stage II (SGB/RNY/SG only) Begin this stage 10-24 days after surgery and continue until two months. You may now supplement your Stage I diet with various soft foods, such as mashed potatoes, applesauce and oatmeal. All foods must be of the consistency of thinned mashed potatoes and fit through a strainer. You should eat between six and eight small meals per day. Low-calorie liquids should be sipped slowly between meals to prevent dehydration. o Food Examples: • Blended creamed soups • Thin blended casseroles • Thinned stage 1 baby food • Low-carbohydrate/high-protein shakes • Skim milk shakes (substitute soy milk or lactaid milk, if needed) • Unsweetened instant breakfast made with skim milk • Blended fruit added to shakes made with skim milk • Blended meat added to blended cream soups • Pureed fruits and vegetables • Cooked cereal thinned with skim milk (oatmeal, grits, cream of wheat, cream of rice) • Yogurt shakes made with sugar-free yogurt and fruit juice • Unsweetened applesauce • Mashed potatoes • Blended sugar-free yogurt • Sugar-free pudding • Add non-fat dry milk powder to foods and beverages to increase protein intake • Avoid coffee, teas, sodas, skin of raw fruits and vegetables, dried fruits, seeds and nuts, concentrated sugars, sweets, alcohol, straws Stage III (SGB/RNY/SG only)

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This stage can begin around one to two months after surgery. Your choices can now include most foods taken in moderation. Care must be taken to avoid foods high in sugar or fats in order to avoid the dumping syndrome. Most patients eat four to six small meals daily. Foods should be soft enough to mash with a fork. Continue to slowly drink low-calorie liquids between meals. o Food Examples: • Baked fish • Soft casseroles, such as macaroni & cheese or tuna • Chopped lean meat • Cooked vegetables (peeled) • Canned fruits • Juices • Crackers • Cottage cheese • Eggs, any type except fried • Skim milk, low-carbohydrate instant breakfast, sugar-free/low-fat yogurt • Canned chicken • Fat-free refried beans • Avoid any food that causes gastric discomfort, coffee, teas, sodas, concentrated sugars, sweets, skin of raw fruits and vegetables, dried fruits, seeds, nuts and alcohol Modified Regular Diet (SGB/RNY/SG and AGB) Gradually introduce new foods one at a time. If one food is not tolerated -- causing diarrhea, vomiting or nausea -- wait one week or more and try again. Pay close attention to your body for signals. Chew slowly and thoroughly. Keep amounts small and consistent. o Keep in mind you are re-educating your stomach. When you eat too fast, too much or don’t chew enough, you will feel discomfort. o Add breads, pasta and meats last. They tend to form a ball and cause difficulty with movement through your new stomach tube or pouch. Be cautious of grapes, apples or other fruits with tough skins or peels. Continue to avoid dried fruits, nuts or seeds. o The most successful weight loss uses a meal plan that provides adequate protein (1.0 to 1.5 gram protein/kg of body weight), is low in sugar and other refined carbohydrates and moderate in fat. It is best to eat high-protein foods at the beginning of each meal. o Continue to take your multivitamins with minerals three times per day. o Chew food 20-30 times before swallowing. o Continue to drink low-calorie liquids slowly between meals. o The recommended fluid intake is 64 ounces (eight cups) between meals. o Monitor fat : • AVOID high-fat foods, such as:

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o Olives, nuts, avocados, regular mayonnaise, sour cream, cream cheese, pie crust, whole milk, butter or margarine, peanut butter, granola, muffins, coleslaw, potato salad, whole milk cheese, ice cream, shortening (lard), regular salad dressings, sauces, fried foods, bacon, sausage, bologna, regular potato chips, doughnuts, fried or fatty foods, sweets, gravy •

USE low-fat cooking tips o Use the leanest meats o Fish: good choices include flounder, sole, light tuna in water, crab, salmon, tilapia o Chicken and turkey breast, no skin (white meat is lower in fat than dark) o Beef: top round, loin, select o Pork: pork loin, pork leg o Trim fat off of meat o Use low-fat cooking methods: bake, grill, sauté, broil o Drain off excess fat after cooking o Avoid high-fat sauces made with cream, cheese, oil or butter o Use cooking methods that require little or no added fat: steam, microwave or bake o Choose low-fat or no-fat salad dressings o Add balsamic vinegar, fat-free salad dressing, lemon juice or herbs o Add vegetables such as grated carrots and fresh tomatoes to spaghetti sauces o When preparing soups, let cool; then skim fat off top USE low-fat substitutions: o Mayonnaise (1 tablespoon)--------- use non-fat/sugar-free yogurt o Ground beef (4 ounces)-------------- use ground turkey breast o Whole egg (1)--------------------------- use two egg whites o Oil (1 tablespoon)---------------------- use fat-free chicken broth o Whole milk (1 cup)---------------------- use skim milk

Optional Supplements The recommendation is to consume 70 grams of protein per day or 1.0 to 1.5 grams of protein/kg per day. Many options exist: o Whey protein: one to three tablespoons added to daily yogurt. Adequate daily protein may help maintain muscle mass. o Creatine: This naturally occurring substance is made from amino acids. It may increase muscle mass, energy and endurance. Creatine monohydrate is taken as 7,500mg of powder mixed in three ounces of liquid, one to three times daily. o Glutamine: This amino acid has been shown to promote muscle mass and intestinal health. The dosage is one to five grams mixed in yogurt two to four times daily. o Protein cans or shakes can also be used, especially as a snack “on the go.” Attention: You should read the entire package insert for supplements and medications carefully and completely. Pay particular attention to possible side effects and warnings. What is the process for future follow up? Clinic Visits:

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o Follow-up consists of an initial postoperative clinic visit approximately five to seven days following surgery. You must return to the clinic for follow up evaluation and education the week following your operation. o Follow up frequency for SGB/RNY/SG: • 1, 6 and 12 months postoperatively, and every year thereafter • Lab work annually and as recommended by your surgeon (Refer to Appendix #3) o Follow up frequency for AGB: • 1, 3, 6 and 12 months postoperatively, and every year thereafter • Lab work annually and as recommended by your surgeon (Refer to Appendix #4) Cornerstone Laboratory Services located at: 1814 Westchester Drive, Suite 400 High Point, North Carolina 27262 Phone: 336-802-2130 Hours: Monday - Friday 7:45am - 7:00pm Saturday 8:00am – 5:00pm Sunday 11:00am – 5:00pm o Weight-loss surgery carries known and unknown long-term risks; therefore weight-loss surgery patients need life-long health surveillance. For this reason, each patient is required to follow up with his or her primary care physician annually to assist with long-term medical management. Refer to Appendix #4 for documentation for these visits. Proper documentation by the physician can be faxed to 336-878-6412. Adjustable Gastric Band Fills/Adjustments: o Overview of an adjustment  Adjustments may be necessary as long as you have your gastric band. Adjustments are not additional surgeries. An adjustment can be performed at a healthcare professional’s office, clinic or hospital.  During adjustments, saline is added to (or removed from) the band by way of the port. Saline travels from the port through the tube and into the band.  Fills tighten the band to increase the amount of restriction at the area between the small pouch and the lower portion of the stomach known as the “stoma.”  You will feel full sooner and longer than before a fill because food will empty from your upper stomach more slowly.  You will probably receive your first fill about six weeks after surgery when swelling from the surgical procedure and placement of the band reduces (usually after you have been eating solid food for about one week).  If you are losing one to two pounds a week and are feeling satisfied with an appropriate portion of food, you may postpone your adjustment until another follow-up visit.  The entire adjustment process usually takes five to ten minutes. o The Four Steps to an Adjustment  Preparing for an adjustment: You will need to have an empty stomach each time you have a band adjustment. Do not eat any soft or solid food for two hours before the adjustment.  Locating the injection port: The clinician uses one of two methods to locate the port. Sometimes a special video image, called fluoroscopy, is used. Other times, the clinician will find the port by gently pressing on your abdomen. 25


 

Inserting (or removing) saline: The clinician will disinfect the skin. A fine needle will be placed through the skin down into the port that is just below the skin surface. During a fill, a specific amount of saline will be injected into the port. Checking for band tightness: The clinician will check your band tightness. You may be asked to drink small sips of water to make sure you can swallow.

o After an Adjustment  After an adjustment you will return to liquids for a day, then soft foods for one or two days. You will feel more restriction during a meal after a fill.  It may take several fills to reach the point where the amount of saline in the band is adequate to provide restriction and continued weight loss (one to two pounds per week).  The ideal fill level may change as you lose weight. If you notice that you can eat larger quantities of food without uncomfortable side effects, or have vomiting, night coughs, hiccups or symptoms of acid reflux, talk to your clinician. This may indicate that you need to have another band adjustment. Exercise: o Exercise is a key to achieving and maintaining ideal weight loss after weight-loss surgery. Getting started on a gradual exercise and physical activity plan is very important. o Immediately following surgery, conventional exercise will be difficult. Modified exercise in the form of getting out of bed and walking will start hours after your surgery. Over time, the type of exercise that is most appropriate will depend on your physical limitations as you lose weight. Staff at the HeartStrides Fitness Center (336 878-6221) will be happy to meet with you individually to discuss program options and to help establish an individual exercise plan. o We recommend all patients get at least 30 minutes of cardiovascular physical activity, six days a week. o Contact Regional Bariatrics to learn more about what fitness options are available.

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RESOURCES Cookbooks o “Eating Well After Weight-loss Surgery: Over 140 Delicious Low-Fat, High Protein Recipes to Enjoy in the Weeks, Months, and Years after Surgery” by Patt Levine, Michele Bonntempo-Saray, and William B. Inabnet. o “Before & After: Living and Eating Well After Weight-loss Surgery: With 100 Low Carb High Protein Recipes for a Healthier, Happier, & Slimmer You” by Susan Maria Leach. o “Recipes for Life After Weight-Loss Surgery: Delicious Dishes For Nourishing the New You. A Healthy Living Cookbook” by Margaret Furtado and Lynette Schulz. Feb. 2007. o “Culinary Classics: Essentials of Cooking for the Gastric Bypass Patient” by David Fouts Miscellaneous Books & Phone Numbers o “The Emotional First Aid Kit: A Practical Guide to Life After Bariatric Surgery” by Cynthia L. Alexander. Feb 2006. o “Weight-loss Surgery for Dummies” by Marina S. Kurian, Barbara Thompson, and Brian K. Davidson. 2005. o HeartStrides Fitness Center at High Point Regional Hospital, Dietician 336-878-6000, ext. 2370 Websites o UNJURY® is a great-tasting protein supplement powder that provides the highest quality protein: http://www.unjury.com o The Regional Center for Bariatric Surgery Website: http://www.regionalbariatrics.com o American Society for Metabolic and Bariatric Surgery: http://www.asbs.org/ o Nutritional supplements: http://www.bariatricadvantage.com o Nutritional supplements: http://www.vitalady.com o Probiotics Help Adult Weight Loss After Bariatric Surgery. The Washington Post. May 22, 2008 o http://www.washingtonpost.com/wp-dyn/content/article/2008/05/22/AR2008052202984.html o Bariatric Surgery by Itself Isn't Enough June 2, 2008 The Los Angeles Times http://www.latimes.com/features/health/la-he-bariatric2-2008jun02,1,6951595.story o Health Risks of Obesity" http://www.annecollins.com/obesity/risks-of-obesity.htm o Gastric Bypass Surgery: What Can You Expect? http://www.mayoclinic.com/health/gastricbypass/HQ01465 o Life After Bariatric Surgery: The Weight-loss Surgery Lifestyle. http://www.obesityhelp.com/content/lifeafter.html o Bariatric Message Board at Yahoo Groups

HPMGBfriends-subscribe@yahoogroups.com

o Is Weight-loss Surgery for You? www.webmd.com/diet/weight-loss-surgery/surgery-for-you

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APPENDIX #1 – RESULTS AND COMPLICATION RATES Gastric Banding – National Averages • 0.1% mortality rate • 2% migration of implant • 5.4% tubing-related complications • 2% other complications Sleeve-Gastric Bypass/Roux en Y Gastric Bypass- Regional Center for Bariatric Surgery Program Averages • 0.12% mortality rate (1 out of 850 patients) • 0.6% leak rate (5 out of 850 patients) • 0.12% deep venous thrombosis (DVT) rate (1 out of 850 patients)

Improvement in Co-Morbidities

Procedure

Obesity

Diabetes

High Blood Pressure

High Cholesterol

Sleep Apnea

Acid Reflux

Adjustable Band

60%

48%

43%

78%

95%

32%

Sleeve-Gastric Bypass or RNYGB

72%

92%

78%

81%

95%

33%

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APPENDIX #2 - REQUIRED COMPONENTS FOR YOUR “APPLICATION PACKET” Required Components for your Application Packet _____ Doctor’s Letter In the letter, your physician should state that they support your desire to undergo weight-loss surgery (specify procedure) and are willing to be actively involved with your care postoperatively. This includes, but is not limited to, drawing blood for specific tests and forwarding the results to the Bariatric Center for review by you surgeon. There may be occasions when your doctor and your surgeon will consult each other regarding your postoperative treatment. _____ Medical Information Medical information is to be current – within six months of your surgery date Chest X-ray and EKG is to be within six weeks of surgery date Laboratory Reports is to be within 60 days prior to surgery  Physical Examination/progress notes from your physician visit.  History and Physical should include: allergies, current medications and dosage, past surgeries and any other information related to health.  Laboratory Reports – CBC, CMP, TSH  EKG: a copy of the tracing and interpretation  History of tobacco usage  Chest film - if you are a smoker, have been a smoker, have had or currently have lung issues, or have high blood pressure  Pulmonary Status – history of asthma or any other lung condition. If you have COPD you will need to have a pulmonary function test done with a pulmonologist.  Specialists- If you are routinely seeing a specialist (such as a cardiologist, pulmonologist, please provide a statement from the physician that includes your medical reports and a statement of clearance for surgery.  Sleep Apnea: If you have sleep apnea you will need an evaluation and clearance for surgery. ____

Psychological Evaluation Performed by a licensed psychiatrist or psychologist within six months of surgery date (a document including the information needed is included). The most important reason for this assessment is to provide you with a friendly face to help with any postoperative stress or depression. Some patients will have significant mood swings after surgery and having this support mechanism in place is essential.

____

Patient Letter This is your biggest task. The letter is to be typed in standard 12-point font and address each of the following subjects. Each topic should receive from one half to a full page of writing. Information for this letter can be found in the manual and the consent form on the website. www.regionalbariatrics.com 1. Health Risks of Obesity 2. How is the AGB/MGB/RNY performed? 3. Short-term risks 4. Long-term risks 5. Lifestyle changes 6. Expectations after surgery

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7. Need for long-term follow-up 8. Alternatives to surgery 9. Different types of weight-loss surgeries ___

Family-Support Letter • If you are married, you must have a support letter from your spouse. If not, a letter from a child, parents or friend expressing their understanding of the procedure as well as their support for your decision. This letter must be notarized. • Your support person must accompany you to the information seminar and your pre-operative educational class and be available the day of the operation and while you are in town after the operation.

___

Document your contact with at least 10 Bariatric Surgery patients

___

Photograph • We ask for front- and side-view photographs of you in a bathing suit or tight fitting clothes to help us assess the shape of your abdominal cavity. Do not include nude photos. • Include your waist size when you submit your photograph.

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APPENDIX #3 - RECOMMENDED ANNUAL SGB/RNY BLOOD TESTS • • • • • • • • • • • • • • • • • • • • • •

Vitamin A Vitamin B6 (Pyridoxal phosphate level) Vitamin B-12 level Vitamin E Vitamin D, 250H Copper Calcium Magnesium Phosphorous Zinc Folate Prealbumin/Total Protein/Albumin Iron/TIBC, Ferritin, Transferrin CBC (Complete Blood Count), Hemoglobin and Hematocrit Chem. 7 (Comprehensive Metabolic Panel) Liver Panel: SGOT/SGPT, Alk Phos, T/D Bilirubin Cholesterol/Triglyceride Levels Hemoglobin A1C level (only if patient was diabetic before surgery) DHEA TSH,T4 (required if have thyroid disease) PTH Thiamin B1

RECOMMENDED ANNUAL AGB BLOOD TESTS • • • • • • •

CBC Chem. 7 Cholesterol/Triglycerides H3 A1C (If patient had Diabetes Mellitus previously or currently) Vitamin D Vitamin B12 PTH

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APPENDIX #4 – FOLLOW-UP FORM  1 Month  6 Months  Annual

Surgeon:  Dr Walsh

 Dr Dasher

Today’s Date: _______________________ MGB Surgery Date: ______________ Name: ___________________________________________________________________ Address: ___________________________________________________________________ Home Phone: ____________________________ Cell Phone: __________________________ E-Mail Address: ______________________________________________________________ Your Weight: Pre-Op: _____ lbs. Current: _____ lbs. Lowest: _____ lbs. Waist Measurement: Pre-Op: _____ in. Current: _____ in. Before Surgery Symptom Co-Morbidity Depression Diabetes - Use of Insulin? Shortness of Breath Sleep Apnea - Use of CPAP/BIPAP Machine? High Blood Pressure High Cholesterol Incontinence Bowel Obstruction Hernia Ulcer Vomiting (once a week or more) Heartburn (once a week or more) GERD Gall Bladder Surgery Bile Reflex Endoscopy of your Esophagus or Stomach Esophagitis

Yes                   

No                   

After Surgery Yes                   

No                   

If "No"-- How long after surgery did symptom resolve?

Any other post operative complications? Y  N  Explain: ______________________________________________________________ List current medications (and dosage) you are taking – include over-the-counter medications and why you are taking it. Medication

Dosage

Why taking

When you began taking

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Are there any medications that you were taking prior to your surgery that you no longer take or now take a lower dosage of? Y  N  If yes, please list: ___________________________________________________________________ Have you changed physicians since your MGB? Y  N  If yes, please list as much of the information below as possible: Present Doctor: _______________________________________________________ Address:____________________________________________________________ Phone: ______________________________ Fax: ___________________________ Mail Address: When did you last forward a copy of your lab results to us? ____________________ Please have your doctor fax any lab results to our office: (336) 878-6412 !

APPENDIX #5 – SGB INFORMED CONSENT FORM SLEEVE-GASTRIC BYPASS O P E R A T I V E C O N S E NT You are asked to please read this document very carefully! As you read each paragraph you are encouraged to discuss any questions about it with your surgeon. If you agree with everything in each paragraph as you read it, you are asked to:  Write your initials next to each paragraph  Check the box at the end of the paragraph  Write at least two sentences or more describing the paragraph and showing your understanding of what you have read 1.

PREOPERATIVE INFORMATION AND EDUCATION - initial here ____

My initials and comments in this form are meant to demonstrate that I understand and completely agree that I have been given extensive preoperative education and information about obesity, the risks of obesity and the risks and possible benefits of the surgical procedures in general and the Sleeve-Gastric Bypass, also known as mini-gastric bypass, in particular. I understand that this consent form is designed to provide a written confirmation of these discussions with my surgeon and the extensive educational process that I have participated in by repeating and recording some of the more significant medical information given to me. I understand that the effort of this long document purposefully intended to make me think over my decision to have surgery once again. I confirm that my family, my doctor and I have extensively reviewed the decision to proceed with this weight-loss surgery. This document is a written record of my efforts to be well informed about my decision to proceed with operation. I can confirm that I wish to consent to go forward with the proposed Sleeve-Gastric Bypass procedure. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________

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__________________________________________________________________________________________ __________________________________________________________________________________________ 2.

PROPOSED PROCEDURE - initial here ____

Sleeve-Gastric Bypass also known as Mini-Gastric Bypass: I understand that the procedure that my surgeon has recommended for the treatment of my obesity is the Sleeve-Gastric Bypass. My surgeon, my doctor, my family and many patients that have undergone Sleeve-Gastric Bypass have provided me with a detailed explanation of the medical history of the development of the surgical treatment of obesity, gastric surgery as a treatment of obesity, the development of laparoscopic (minimally invasive) surgery and the Sleeve-Gastric Bypass. I have been provided with drawings, photographs, written and verbal descriptions of the operation and other alternative surgeries including Roux-en-Y Gastric Bypass, Billroth II, “Old Loop” Gastric Bypass, Gastric Band, and others. I have been encouraged to talk with patients that have previously undergone the Sleeve-Gastric Bypass surgery. I have attended informational group seminar. I have been invited to support group meetings and encouraged to attend similar meetings for other types of bariatric surgery. I believe I have been well educated regarding the procedure and alternatives, including no surgery. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ 3.

CONTROVERSY IN MEDICINE OVER THE SURGICAL TREATMENT OF OBESITY - initial here ___

I realize there are many types of weight-loss surgery and the medical community has many conflicting opinions regarding surgery for obesity. There are many physicians who believe bariatric surgery should never be considered. There are many surgeons who only believe in their particular type of surgery. I clearly realize that there are a variety of different types of weight Sleeve-Gastric Bypass loss surgery, some of which are shown in the table  Sleeve gastrectomy below:  Roux-Y bypass  Gastric banding Table 1: Different  Duodenal switch Types of Weight-loss Surgery  Laparoscopic and open versions of most surgery types  Many others

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No one surgery has been accepted as the best weight-loss option by all physicians. I could have chosen any type of weight-loss surgery and after careful consideration have decided upon a Sleeve-Gastric Bypass. 4.

THE “OLD LOOP” GASTRIC BYPASS - initial here ____

I know that some critics of the Sleeve-Gastric Bypass have compared it to the “Mason Loop” or "Old Loop" Gastric Bypass. The following figures and discussion explain the differences between the SleeveGastric Bypass, the Standard Billroth II and the "Old Loop" Gastric Bypass. The Billroth II is the most commonly performed type of connection between the stomach and the small bowel. The Billroth II is a surgical procedure used routinely in the treatment of trauma, stomach cancer and peptic ulcers. In the usual Billroth II, the esophagus and the body of the stomach are distant from the Billroth II connection. The Billroth II connects the stomach to the jejunum, the upper-middle portion of the small intestine. Like the Mini-Gastric Bypass, the standard Billroth II places the connection between the stomach and the small bowel low on the stomach at the junction between the body and the antrum of the stomach. The lower part of the stomach is often removed in the usual Billroth II surgery.

The “Old Loop” The "Old Loop'' Gastric Bypass included a small high stomach pouch that was placed high up on the stomach close to the esophagus. The loop that carries bile was placed close to the esophagus and this led to the associated problems with esophagitis that occurred in some surgeon's experience with the ''old loop'' type gastric bypass. This configuration is in many ways much like the common general surgical procedure called a total gastrectomy. It is widely agreed that a total gastrectomy is not a good choice for a Billroth II reconstruction. This "old loop" is quite different from the Sleeve-Gastric Bypass. The “Old Loop'' created a stomach pouch that was also based upon the outside edge of the stomach. This kind of pouch commonly stretches leading to failure of weight loss.

Sleeve-Gastric Bypass Sleeve-Gastric Bypass does have a Billroth II type loop connection like the ''old loop'' bypass, but the loop in the Sleeve-Gastric Bypass is placed low on the stomach far away from the esophagus. This is in the same position as the loop in the standard Billroth II done for ulcers and other diseases. The Sleeve-Gastric Bypass creates a long narrow "gastric tube'' that places the connection of the stomach and the bowel low in the stomach and keeps the stream of bile away from the esophagus. The other advantages are that the surgery is often easily accessible in the event that the surgery needs to be revised.

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If you agree that everything in the above paragraphs is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 5.

RISKS/BENEFITS OF PROPOSED PROCEDURE - initial here ___

Just as there may be some expected benefits from the Sleeve-Gastric Bypass procedure proposed in my case, I also understand that all medical and surgical procedures, including the Sleeve-Gastric Bypass involve risks. I have been told and I understand that my obesity increases my risks of these problems and complications. These risks include: Complications Allergic reactions

Description All kinds of allergic drug and chemical reactions are possible from my treatment, from minor reactions such as a rash to sudden overwhelming reactions that can cause death.

Anesthetic complications

I know and consent to the fact that general anesthesia will be used to put me to “sleep” for the operation. I am aware that the anesthesia has major and minor risks that can be associated with a variety of different complications up to and including death. Some operations, anesthetics and pain-relieving drugs are more likely to cause sickness (nausea) than others. Sickness can be treated with anti-vomiting drugs (anti-emetics), but it may last from a few hours to several days and rarely represent as chronic problem. You will have a tube in your airway to breathe for you and it may give you a sore throat. The discomfort or pain lasts from a few hours to days.

Feeling sick, nausea and vomiting Sore throat

Dizziness, blurred vision Shivering

Headache

Bleeding

If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here: Your anesthetic or loss of fluids may lower your blood pressure If you agree and and make you feel faint. understand, check YES  here Initial here: This may be due to you getting cold during the surgery, to some If you agree and drugs, or to stress. understand, check YES  here Initial here: This may be due to the effects of the anesthetic, to the surgery, to If you agree and lack of fluid, or to anxiety. More severe headaches may occur understand, check after a spinal or epidural anesthetic. YES  here Initial here: Surgery involves incisions and cutting that can result in bleeding If you agree and complications, from minor to massive, that can lead to the need understand, check for emergency surgery, transfusion or death. YES  here

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Complications

Description

Blood clots

In addition, Deep Vein Thrombosis (DVT) and Pulmonary Embolus can sometimes cause death. In the 700 people that have had the Mini-Gastric Bypass at High Point, one has developed clots in their legs (Deep Vein Thrombosis) and none have had a pulmonary embolus. This is lower than seen in other series of gastric bypass surgery, but it can still happen. I understand that I need to get out of bed the evening after surgery, move, and flex my feet and legs to try to help prevent clots from forming in my legs. I also know that although other surgeons routinely use “blood thinners” to prevent clots that they can cause bleeding complications and are not used by my surgeon for the MiniGastric Bypass. Including wound infections, bladder infections, pneumonia, skin infections and deep abdominal infections can sometimes lead to death.

Infection

Leak

After operation to bypass the stomach, the new connections can leak stomach acid, bacteria and digestive enzymes causing a severe abscess and infection, This can require repeated surgery and intensive care and even death. In the over 700 patients that have had the Mini-Gastric Bypass at High Point, less than 1% have developed a leak. Narrowing Narrowing (stricture), inflammation and/or ulceration of the (stricture) connection between the stomach and the small bowel can occur after the operation. This can require emergency operation, intensive care and can sometimes lead to death. To protect your new stomach from ulcers, you must never again take aspirin or aspirin like drugs such as Motrin, Naproxen, Relafen or other similar drugs. Indigestion The operation can sometimes lead to severe nausea, vomiting, acid/bile reflux indigestion, abdominal pain, gastritis or ulcers. This can be severe or ulcers and can last for days, weeks and possibly even longer. This is especially likely if you have had previous problems with nausea, abdominal pain or ulcers. Chronic gastritis has been found in many patients years after the Billroth II. Biliary duodeno-gastroesophageal reflux can be injurious on the mucosa of the stomach and the esophagus. If bile reflux occurs, and it causes problems, the operation can be revised. In most cases, revision is not necessary. Bile Reflux of bile acids into the esophagus may contribute to injury of the esophageal lining. Bile is a component of digestive juices normally present in the small intestine. Bile can reflux from the small intestine into the stomach and does so normally. However, in a subset or people who have severe GERD (backwashing of acid and bile into the esophagus) including in those who have Barrett's esophagus, there is an increase for back washing into the esophagus. Although acid plays a primary role in the development of Barrett's esophagus, there is evidence that bile

Initial here: If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here:

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Complications

Dumping syndrome

Bowel Obstruction Laparoscopic surgery risks

Description reflux adds to the effect of acid injury to the esophagus, and therefore, may contribute to the development or Barrett's esophagus and possibly esophageal adenocarcinoma (cancer). Dumping Syndrome (Symptoms of the dumping syndrome include cardiovascular problems with weakness, sweating, nausea, diarrhea and dizziness) can occur in some patients after gastric bypass. This can be so severe that the surgery may have to be reversed or revised. Any abdominal operation can leave behind scar tissue that can put the patient at risk for later bowel blockage or obstruction. The bowel can twist, obstruct and even perforate leading to serious complications and even death. Laparoscopic Surgery uses punctures to enter the abdomen and this can lead to abdominal organ and/or blood vessel injury, bleeding and even death.

Side effects of drugs

All drugs have inherent risks and complications and in some cases can cause a wide variety of side effects, reactions and in some cases including death.

Loss of bodily function

The performance of surgery and anesthesia can stress the body's systems leading to a variety of complications including nerve damage, stroke, heart attack, limb loss and other problems related to operation and anesthesia. Including Hepatitis and Acquired Immune Deficiency Syndrome (AIDS), from the administration of blood and/or blood components. These illnesses are serious and can be fatal.

Risks of transfusion Hernia

Hair loss

Vitamin and mineral deficiencies

Cuts and incisions in the abdominal wall can lead to hernias after surgery. Hernias can lead to pain, bowel blockage, obstruction and even perforation and death in some cases. Treatment of hernias usually requires another operation. Many patients develop hair loss for a period after the operation. When this occurs, it usually starts around 3-4 months after surgery and resolves at 7-9 months after the operation. This usually responds to increased oral intake of protein and vitamins, but it may be permanent. After gastric bypass there is a malabsorption of many vitamins and minerals. Patients must take vitamin and mineral supplements forever to protect themselves from these problems. I know that I also need to have yearly blood tests to measure the blood levels of these vitamins and minerals. Common deficiencies that can occur after gastric bypass include iron and calcium deficiency, B12 and Folate deficiencies. I know there is a risk of Wernicke's encephalopathy and other rare nerve and brain damage if I do not carefully follow these instructions. I know that this is very important: Patients must take vitamin and mineral supplements forever. In some cases the deficiencies are so severe that they can lead to nerve and brain damage and the operation must be

If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here:

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Complications Inadequate weight loss

Excessive weight loss Complications of pregnancy

Unplanned pregnancy

Other

Depression

Description reversed. WARNING: Remember that you might not lose weight after the operation. You might gain weight and/or have problems with weight after surgery. *There are patients that will fail any type of surgery. Inadequate weight loss is a risk of all types of weight-loss surgery and indeed of all types of weight-loss treatment. I recognize that the Mini-Gastric Bypass is not by any means a perfect treatment and that one of the risks that I face is a real possibility of inadequate weight loss following my Mini-Gastric Bypass surgery. Excess weight loss occurs in about 1% of patients and may require revisional surgery to correct. It is important to alert the medical/surgical providers EARLY if you think you may be losing too much weight. Vitamin and mineral deficiencies can put the newborn babies of gastric bypass mothers at risk. No pregnancy should occur for the first one to two years after operation. Gastric Bypass has been shown to cause multiple types of vitamin and mineral deficiencies including: iron, B12, Folate, calcium and many others. Many of these deficiencies have been shown to cause birth defects or are suspected that they could cause birth defects. We also know that many patients who lose weight feel that they are well after surgery and forget to take their vitamins. Patients must be certain not to miss any of their vitamins if they decide to go ahead with pregnancy later. Warning to women using Oral Contraceptives (Birth Control Pills): Millions of women worldwide take ''the pill'' to prevent pregnancy. Typical failure rates among pill users are as high as 12% to 20% in some surveys. Other factors have been shown to increase the risk of pill failure: smoking, diarrhea and/or vomiting, drug interactions, systemic illness, psychological stress, and menstrual disturbances. Therefore, it is important to recognize that Birth Control Pills may not be an effective method of birth control after the Mini-Gastric Bypass until those factors have resolved. We have found on several occasions that in many cases the hormonal methods of birth control fail after MiniGastric Bypass. Couples need to plan another form of nonhormonal birth control for 6-12 months after surgery. DepoProvera has also been associated with marked cases of nausea in post MGB patients. An unplanned pregnancy can be one of life's most difficult experiences. Major abdominal surgery, including the Mini-Gastric Bypass, is associated with a large variety of other risks and complications, both recognized and unrecognized that occur both soon after and long after the operation. Depression and anxiety are common medical illnesses and have been found to be particularly common after operation.

If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here: If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here:

If you agree and understand, check YES  here Initial here: If you agree and understand, check

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Complications Cancer

Description

YES  here Initial here: If you agree and understand, check YES  here Initial here:

Cancer can occur in anyone. Many cancers are more common in obese as compared to thin patients. Overweight men have a significantly higher rate of prostate cancer. Obese women have higher risks of developing breast cancer and cancer of the uterus and ovaries. It is expected, but not certain, that with weight loss you will have an overall decrease in your risk of cancer. The Billroth II connection used in the Mini-Gastric Bypass has been used for almost 100 years and is performed over 16,000 times a year in America to connect the stomach to the bowel. Some studies have suggested that the Billroth II connection used in the Mini-Gastric Bypass can increase the risk of stomach cancer while others do not show this. The studies showing increase risk of stomach cancer are in Billroth II patients that had the surgery for ulcers, and since ulcers can cause an increased risk of stomach cancer, it may be the stomach ulcer not the Billroth II that causes some studies to show increased risk of stomach cancer after the Billroth II. Diet seems to be much more important as a cause of stomach cancer. Eating processed meats has a much greater effect on increasing stomach cancer risk that the Billroth II. Conversely, fresh fruits and vegetables seem to protect against stomach cancer. In the end no one knows what will happen in your case, and if you are concerned about stomach cancer then you could either 1) Not have the Sleeve-Gastric Bypass. 2) Have the Sleeve-Gastric Bypass and avoid processed meats and eat more fresh fruits and vegetables. In either case stomach cancer is an unlikely event. Death This is a major and serious operation. It may lead to death from If you agree and complications. There has been a death in the first week after this understand, check surgery in one patient. YES  here Initial here: If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 6.

SPECIAL WARNING ABOUT THE RISKS OF BIRTH DEFECTS AFTER GASTRIC BYPASS - initial here ___

Vitamin and mineral deficiencies can put the newborn babies or gastric bypass mothers at special risk of Major Birth Defects. No pregnancy should occur for the first one to two years after operation. Gastric Bypass has been shown to cause multiple types of vitamin and mineral deficiencies including: iron, B12, Folate, calcium, and many others. Many of these deficiencies have been shown to cause birth defects or are suspected that they could cause birth defects. We also know that many patients who lose weight feel that they are well after surgery and forget to take their vitamins. Patients must be certain not to miss any of their vitamins if they decide to go ahead with pregnancy later. Warning to women using Oral Contraceptives (Birth Control Pills): Many women take 'the 40


pill' to prevent pregnancy. Typical failure rates among pill users are as high as 12% to 20% in some surveys. Other factors have been shown to increase the risk of pill failure: smoking, diarrhea and/or vomiting drug interactions, systemic illness, psychological stress, and menstrual disturbances. Therefore, BC pills may not be an effective method after the Mini-Gastric Bypass until those factors have resolved. An unplanned pregnancy, can be one of life's most difficult experiences. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 7.

PARTICULAR RISKS ASSOCIATED WITH THE SLEEVE-GASTRIC BYPASS - initial here ___

I also realize that there are particular risks associated with the Sleeve-Gastric Bypass procedure proposed for me and that these risks include, but are not limited to: bleeding, leak, abscess and serious intra-abdominal infection and blood clots, all of which can lead to repeated operation, admission to the intensive care unit and sometimes death. I realize that my surgeon plans to perform the operation laparoscopically, and that this approach has special risks including injury to the abdominal contents such as blood vessels, the bowel and other organs. I may also need a larger or “open” incision due to technical issues or unexpected operative findings. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ 8.

FOLLOW UP - initial here ___

I recognize that an operation upon my stomach and upper digestive tract is a serious under taking with known long-term risks that my surgeon and educational program have described to me including hair loss, serious vitamin and mineral deficiencies and other known and unknown problems. I am committed to fulfilling my surgeon’s instructions for long-term follow up. I promise I will make every effort to follow his directions to protect myself from these and other problems associated with the bypass. I will not leave the area following surgery for seven days after surgery and until I have been seen in my surgeon’s clinic and have been approved for discharge from the area. I will return to my surgeon’s clinic at 1, 3 and 6 months following surgery and every year thereafter for evaluation and further education. In extraordinary circumstances in which I cannot reach my surgeon’s clinic I will go to my local medical Doctor’s clinic and with his/her approval complete that follow up visit with my local medical doctor. In that event I will make certain that my medical doctor forwards copies of my clinic visit to my surgeon. I understand and agree that my surgeon expects me to return to his clinic for follow up and it is only in unusual circumstances that I will miss these appointments. I promise that I will go to the High Point Regional Health System web site at www.highpointregional.com and complete the “Patient Follow Up Form” monthly after surgery. As part of my commitment to careful follow up, I promise to alert my surgeon’s office of any changes in my address, telephone numbers, email address or health status. If you agree that everything in the above paragraph is correct, check YES here.  41


Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________

9.

FOLLOW UP EMERGENCY TELEPHONE NUMBER - initial here ___

I recognize that an operation upon my stomach and upper digestive tract is a serious undertaking with known risks that my surgeon and educational program have described to me. I understand the signs and symptoms of complications that require emergency attention: a sustained heart rate of > 120 beats per minute during the first 30 days post operatively, uncontrollable vomiting, or abdominal pain for the rest of my life. I promise I will stay in the area within one hour of the hospital and provide a telephone number so I can always be contacted. Emergency Telephone Contact Number: _________________________________ If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 10. UNEXPECTED OUTCOMES – initial here ___ I know that the practice of medicine and surgery is not an exact science and I acknowledge that no guarantee has been made about the results that may be obtained from this procedure. I am aware that in the practice of medicine, other unexpected problems, risks, or complications not discussed may occur. I also understand that during the course of the proposed procedure unforeseen conditions may be revealed requiring the performance of additional procedures, and I authorize such procedures to be performed. I further acknowledge that no guarantees or promises have been made to me concerning the results of any procedure or treatment. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 11. MEDICAL PROVIDERS – initial here ___ Cornerstone Surgery is composed of board certified surgeons and physician assistants as well as nurses and certified medical assistants. Any or all of these individuals may be involved in your surgical care. Other specialists/consultants may also be enlisted as needed for your medical care. If you agree that everything in the above paragraph is correct, check YES here. 

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Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 12. DANGER OF LEAVING THE AREA – initial here ___ I recognize the serious nature of this Gastric Bypass surgery. I am well informed about the risk and potential for unforeseen complications and even death. I am aware that I need to stay in the area near the hospital to allow my surgeon to be able to diagnose and treat any unexpected problems or complications. I therefore confirm that I am aware I must stay in the area for at least seven days so I can be available for treatment and appropriate care. I recognize that other procedures might need to he performed. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences):

13. ACKNOWLEDGEMENTS – initial here ___ The available alternatives to the Mini-Gastric Bypass, some of which include: Open Gastric Bypass, Roux-en-Y Gastric Bypass, Vertical Banded Gastroplasty, various diet, exercise and drug treatments have been explained and discussed in detail with me. The potential benefits and risks of the proposed Sleeve-Gastric Bypass procedure and the likely results with other treatments have been discussed with me in detail. I understand what has been discussed with me as well as the contents of this consent form and have been given the opportunity to ask questions and have received satisfactory answers. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ 14. AUTHORIZATION FOR RELEASE MEDICAL INFORMATION – initial here ___ I hereby confirm that I freely approve of the release of my medical information for the purposes of education and advocacy of the rights of obese patients and that I have not in any way been coerced into this authorization. I recognize that I can refuse to approve of this use of my personal medical information with no negative impact upon my care or treatment by the surgeons. I have had the opportunity to consider whether or not to approve this use of my personal information and I state that I have not been subjected to coercion or undue influence to agree to this release of information. I hereby authorize the surgeons to use any portions or part of my medical records and information pertaining to the medical history, mental or physical condition, services rendered, or treatment given for the purposes of future patients. I understand that the sole use of this information will be in an

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attempt to help others. The information supplied is to be used to educate individual patients, doctors, as well as other members of the public, including Health Insurance Companies and the New Media. This authorization shall become effective immediately. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 15. CONSENT TO PROCEDURE AND TREATMENT – initial here ___ Having read this form and talked with my surgeon, my signature below acknowledges that: I voluntarily give my authorization and consent to the performance of the Sleeve-Gastric Bypass procedure described above (including the administration of blood and disposal of tissue) by my physician and/or his/her associates assisted by hospital personnel and other trained persons as well as the presence of observers. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ 16. MEDIATION, ARBITRATION AND GOVERNING LAW – initial here ___ I agree that this agreement is governed by the laws of the State of North Carolina. I agree that prior to proceeding to any court action to mediate any dispute, the mediator may be involved in more than one session and the costs will be shared equally for such mediation. In the event of failed mediation, then I agree to proceed to arbitration, and I agree that any dispute arising out of the agreement will be decided by neutral arbitration as provided for by the laws of the state of North Carolina. The mediation and arbitration agreements shall be interpreted by the laws of the state of North Carolina. If you agree that everything in the above paragraph is correct, check YES here.  Write a description of the previous paragraph and comments (more than two sentences): __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ _________________________________________________ Patient Signature

Date __________

_________________________________________________ Patient or other person authorized to sign for patient

Date __________

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_________________________________________________ Witness

Date __________

_________________________________________________ Physician’s Signature

Date __________

APPENDIX #6 – AGB INFORMED CONSENT FORM LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING OPERATIVE CONSENT Patient's Name: ________________________________________________________ Patient's DOB: ___________ Surgery Date: _________________________ The purpose of this document is to confirm in the presence of witnesses your informed request to have Laparoscopic Adjustable Gastric Banding for obesity. You are asked to please read this form very carefully. As you read each paragraph, you are encouraged to discuss any questions about it with your surgeon. If you agree with everything in each paragraph as you read it, you are asked to initial each paragraph after reading. You have been given information about your condition of obesity, the risks of obesity, and the risks and possible benefits of the Laparoscopic Adjustable Gastric Banding surgical procedure. This consent form is designed to provide a written confirmation of these discussions by repeating and recording some of the more significant medical information given to you. It is intended to make you think again about your decision and to make you better informed so that you may be better able to decide whether you wish to give your consent to go forward with the proposed Laparoscopic Adjustable Gastric Banding surgical procedure. Patient Online Education: I have completed the EMMI Patient Education Program for the LAP Band _________ I have completed the Realize My Success Program for the Realize Band __________ Patients must complete both. Office will verify and print document to add to patient packet. Condition/Diagnosis: I recognize that I am severely overweight, with a weight of ______ pounds at____feet_____inches tall. My surgeon has clearly explained to me that this level of obesity has been shown to be unhealthy, and that many scientific studies show that persons at this level of obesity are at increased risk of respiratory disease, high blood pressure, heart disease, high cholesterol, stroke, diabetes, arthritis, clotting problems, cancer, and death, as well as other serious but less serious medical illnesses. If you agree that everything in the above paragraph is correct, initial here: _________

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Procedure Overview, Laparoscopic Adjustable Gastric Banding: During gastric banding surgery, a band is wrapped around the upper stomach to limit food intake and slow the progress of food through the digestive system. The procedure actually consists of the implantation of two medical devices. The first implant, the band, is wrapped completely around the upper part of the stomach. The second implant, the injection port, is attached to the abdominal wall underneath the skin. The AGB is implanted using laparoscopic surgery through several small incisions. A small laparoscopic camera is placed through one of the small incisions and into the abdomen allowing the surgeon to see while placing the band around the stomach. Next tubing is connected to the port and the port is fastened to the abdominal wall underneath layers of skin and tissue. The port is usually fastened (or sutured) on the left or right side, about two inches below the rib cage. The exact location depends upon each person’s body shape and the surgeon’s decision. All incisions are closed with stitches. Proposed Procedure, Laparoscopic Adjustable Gastric Banding: I understand that the procedure my surgeon has recommended for the treatment of my obesity is the Laparoscopic Adjustable Gastric Banding. My surgeon has provided a detailed explanation of the history of the development of the surgical treatment of obesity, the laparoscopic adjustable gastric band as a treatment of obesity, and the laparoscopic adjustable gastric banding procedure itself. I have been provided with drawings, and with both written and verbal descriptions of the operation. I have been permitted to speak with patients who have undergone the surgery. I have been strongly encouraged to make every effort to investigate and understand the details of the operation. If you agree that everything in the above paragraph is correct, initial here: _________ Comments: __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ Risks/Benefits of Proposed Procedure: A. Just as there may be some expected benefits from the Laparoscopic Adjustable Gastric Banding procedure proposed in my case, I also understand that all medical and surgical procedures, including the Laparoscopic Adjustable Gastric Banding involve risks. I have been told and I understand that my obesity increases my risks of these problems and complications. These risks include, but are not limited to, the following: 1. BAND SLIPPAGE/PROLAPSE: The stomach below the band comes up above the band and needs to be reduced. This sometimes can be done by withdrawing the fluid in the band. It may have to be reduced surgically. 2. STOMAL OBSTRUCTION: The outlet from the small stomach becomes swollen making it difficult for food or fluid to pass through. This can be partial or complete. It usually resolves with time but can entail repeat operation or prolonged hospitalization for hydration. 3. ESOPHAGEAL/GASTRIC PERFORATION: The esophagus or stomach can be injured during band placement. This can involve repeat operation or band removal. 4. ESOPHAGEAL DILATATION: The esophagus can enlarge over time. This usually requires fluid removal from the band. If persistent, the band may have to be removed. 5. SPLENIC INJURY: The spleen may be injured during band placement. If bleeding is severe, the spleen may have to be removed. 46


6. EROSION: The band erodes into the stomach. The band will have to be removed, and replaced. 7. PORT AND TUBING PROBLEMS: If the tubing kinks or the access ports tilts or shifts surgical correction may be necessary. 8. BLOOD CLOTS: A Blood clot in the legs, also called deep venous thrombosis, can result in a clot traveling to the lungs, called pulmonary embolism. This can result in death. 9. BLEEDING: Bleeding can require transfusion, which can carry risk of transmissible diseases, such as Hepatitis and HIV. 10. RISKS OF ANESTHESIA: General Anesthesia carries risk of heart attack, pneumonia, heart failure, kidney failure, drug reactions and increases the risk of blood clots 11. INFECTIONS: Wound infections, including port site infections, urinary tract infections, pneumonia, and abdominal cavity infections are possible. 12. DEATH: Although rare, the risk to one’s life is a potential adverse outcome. If you agree that you have been advised regarding all of the items in the above paragraph, and have received answers to any questions you have had regarding this information, initial here: _________ Comments: __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ __________________________________________________________________________________________ B. I also realize that there are particular risks associated with the Laparoscopic Adjustable Gastric Banding procedure proposed for me, and that these risks include, but are not limited to bleeding, erosion, slippage, esophageal dilatation, esophageal/gastric perforation, port site migration, stomach obstruction and blood clots, all of which can lead to repeated operation, admission to the intensive care unit and, sometimes death. I realize that my surgeon plans to perform the operation laparoscopically, and that this approach has special risks, including injury to the abdominal contents such as blood vessels, the bowel, and other organs. Also, I realize that, in the event that the procedure cannot be completed laparoscopically, it will be completed by way of the conventional open surgical approach. If you agree that you have been advised regarding all of the items in the above paragraph, and have received answers to any questions you have had regarding this information, initial here: _________ Complications; Unforeseen Conditions; Results: I know that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantee has been made about the results that may be obtained from this procedure. I am aware that, in the practice of medicine, other unexpected problems, risks, or complications may occur. I also understand that, during the course of the proposed procedure, unforeseen conditions may be revealed, requiring the performance of additional procedures, and I authorize such procedures to be performed. I further acknowledge that no guarantees or promises have been made to me concerning the results of any procedure or treatment.

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If you agree that you have been advised regarding all of the items in the above paragraph, and have received answers to any questions you may have had regarding this information, initial here:_________ Expected Weight Loss: Many studies show band placement can result in 35-50% loss of excess body weight. This is highly dependent upon patient compliance. It is possible, though not likely, to have minimal weight loss after band placement. It is required to have a Nutritional Evaluation before my surgery. This will insure that I am fully aware of the importance of my new diet, exercise and life style change so that I may achieve the maximum weight loss after band placement. If you agree and understand the above statement, initial here: __________

Acknowledgments: The available alternatives to the Laparoscopic Adjustable Gastric Banding, some of which include open gastric bypass, vertical banded gastroplasty, biliopancreatic diversion with/without duodenal switch, laparoscopic gastric bypass, various diet, exercise, and drug treatments have been explained and discussed in detail with me. The potential benefits and risks of the proposed Laparoscopic Adjustable Gastric Banding procedure, and the likely results with other treatments, have been discussed with me in detail. I understand what has been discussed with me, as well as the contents of this consent form, and I have been given the opportunity to ask questions, and have received satisfactory answers. If you agree that everything in the above paragraph is correct, initial here: _________ Follow-Up: I recognize that an operation on my stomach and upper digestive tract is a serious undertaking with known longterm risks that my surgeon and educational program have described to me including hair loss, serious vitamin and mineral deficiencies and other known and unknown problems. I am committed to fulfilling my surgeon’s instructions for long-term follow up. I promise I will make every effort to follow his directions to protect myself from these and other problems associated with gastric banding. I will not leave the area for 7 days after surgery and until I have been seen in my surgeon’s clinic and have been approved for discharge from the area. I will return to my surgeon’s clinic at 1 week for staple removal, 1 month, and 6 months following surgery and every year thereafter for evaluation and further education. I will also schedule to see Bariatric Nutritionist when I receive fills and when recommend by my physician. In extraordinary circumstances in which I cannot reach my surgeon’s clinic I will go to my local medical doctor’s clinic and with his/her approval complete that follow up visit with my local medical doctor. In that event I will make certain that my medical doctor forwards copies of my clinic visit to my surgeon. I understand and agree that my surgeon expects me to return to his clinic for follow up and all band adjustments, it is only in unusual circumstances and with the permission of my surgeon or his staff that I will miss these appointments. As part of my commitment to careful follow up, I promise to alert my surgeon’s office of any changes in my address, telephone numbers, and email address or health status. If I fail to alert my surgeon’s office of any changes in contact information and /or fail to follow the instructions for my care and follow up, I assume all responsibility for any adverse outcomes related to my procedure. If you agree to and understand everything in the above paragraph, initial here: _________

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Consent to Procedure(s) and Treatment: Having read this form, and having discussed its content with my surgeon, my signature below acknowledges that I voluntarily give my authorization and consent to the performance of the Laparoscopic Adjustable Gastric Banding procedure described above (including the administration of blood, and disposal of tissue) by my physician, his associates, hospital personnel, and other trained persons. Patient's Signature: ___________________________________ Date: ________________ Witness: ___________________________________________ Date: _________________

APPENDIX #7 – RNY INFORMED CONSENT FORM

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APPENDIX #8 – SLEEVE GASTRECTOMY CONSENT FORM Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy Patient's Name: _____________________________________________________ Today's Date: _____/_____/________ The purpose of this document is to confirm, in the presence of witnesses, your informed request to have Laparoscopic Sleeve Gastrectomy Surgery for obesity. You are asked to read the following document very carefully. As you read each paragraph, you are encouraged to discuss any questions you have with your surgeon. If you agree with everything in each paragraph as you read it, you are asked to initial each paragraph after reading. You have been given information about your condition of obesity, the risks of obesity, and the risks and possible benefits of the Laparoscopic Sleeve Gastrectomy Surgery procedure. This consent form is designed to provide a written confirmation of these discussions by repeating and recording some of the more significant medical information given to you. It is intended to make you think again about your decision and to make you better informed so that you may be better able to decide whether you wish to give your consent to go forward with the proposed Laparoscopic Sleeve Gastrectomy procedure. Condition/Diagnosis: I recognize that I am severely overweight, with a weight of ______ pounds at ____feet, ____inches tall. My surgeon has clearly explained to me that this level of obesity has been shown to be unhealthy, and that many scientific studies show that persons at this level of obesity are at increased risk of respiratory disease, high blood pressure, heart disease, high cholesterol, stroke, diabetes, arthritis, clotting problems, cancer, and death, as well as other serious medical illnesses. If you agree that everything in the above paragraph is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________

Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy Proposed Procedure: Laparoscopic Sleeve Gastrectomy: I understand that the procedure my surgeon has recommended for the treatment of my obesity is Laparoscopic Sleeve Gastrectomy. My surgeon has provided a detailed explanation of the history of the development of the surgical treatment of obesity, the Laparoscopic Sleeve Gastrectomy as a treatment of obesity, and the Laparoscopic Sleeve Gastrectomy procedure itself. I understand that the procedure involves removal of a major portion of the stomach. After general anesthesia (unconsciousness caused by drugs) is administered, the surgeon enters the abdominal cavity. This procedure is done using a laparoscope (thin, tubular, lighted instrument for viewing the abdominal and pelvic organs), as well as other slender surgical instruments. The instruments are inserted through very small incisions (surgical cuts) in the abdomen. The surgeon will then remove a major portion of the stomach from the abdominal cavity after disconnecting its blood supply. This is performed with surgical staplers and other instruments. The abdominal wall is then closed with stitches. I have been provided with drawings, and with both written and verbal descriptions of the operation. I have been permitted to speak with patients who have undergone the surgery. I have been strongly encouraged to make every effort to investigate and understand the details of the operation. If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______.

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Comments:____________________________________________________________ Expected Benefits of the Proposed Procedure: I understand that the proposed procedure will most often result in weight loss and improvement of obesity related conditions. I understand that with these benefits, I may be able to discontinue or decrease the use of medications that I am currently taking. I fully understand that none of the benefits is guaranteed. I also understand that in order to derive these benefits, I am required to be fully compliant with recommended treatments after surgery including the use of medications, nutritional supplements, specific diets, exercise and behavior modifications. I understand that the benefits derived from surgery may alter or be reversed over time. If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________

Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy Known Risks of the Proposed Procedure: I understand that all medical and surgical procedures involve potential risks and complications, and that my obesity increases the risks of these problems and complications. I understand that complications associated with Laparoscopic Sleeve Gastrectomy include, but are not limited to, the following: 1. Death: Death can occur after Laparoscopic Sleeve Gastrectomy from a number of causes, some of which are listed below. 2. Leak After surgery: the new staple lines can leak stomach acid, bacteria, and digestive enzymes, causing severe infection and abscess formation. This may require repeated surgery, prolonged stay in Intensive Care Unit, and may lead to death. 3. Blood Clots: Blood clots, formed after surgery within the deep veins in the body (Deep Vein Thrombosis) and the veins in the lungs (Pulmonary Embolus), may lead to death. 4. Infection: Wound infections, bladder infections, pneumonia, skin and deep abdominal infections, and other infections can sometimes lead to widespread infection and death. 5. Bleeding: Minor to massive bleeding can occur after surgery, and may require emergency surgery, transfusion, or lead to death. 6. Need for Drugs: All drugs have inherent risks and, in some cases, can cause a wide variety of side effects, including death. 7. Ulceration: Peptic ulcerations may form along the staple lines in the stomach. They make cause pain, and bleeding, and sometime require additional procedures, re-operation, or even lead to death. 8. Narrowing (stenosis): Narrowing (stenosis) can occur within the remaining stomach, requiring additional procedures including repeat surgery. 9. Bowel Obstruction: Any operation in the abdomen can leave behind scar tissue that can put the patient at risk for later bowel blockage. 10. Disruption of Incision: Cuts in the abdominal wall, most of which are closed after surgery, may get disrupted early on after surgery (dehiscence), or at a later time (incisional hernia), requiring second operation. 11. Injury: Inadvertent injury to stomach, intestines, or other abdominal organs may occur during surgery, requiring repair, or resection of the involved bowel or organ. 12. Anemia: Deficiency of iron, and vitamins may lead to anemia (low red blood cell count in the blood). If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________ 13. Removal of Spleen: During surgery, spleen may get injured and if injury is severe, spleen needs to be removed completely. 14. Heart Attack: Heart attack may range from minor to very severe, and may require procedures, medications, and may lead to death.

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15. Stroke: Blood flow to part of the brain may get cut off as a result of blood clots or bleeding. This may result in permanent and irreversible loss of function of a part of body, or if very severe it may lead to death. 16. Protein Deficiency: After Sleeve Gastrectomy, patients may experience protein deficiency due to inadequate intake or absorption, leading to generalized weakness, leg swelling, hair loss, and malnutrition. 17. Allergic Reactions: These range from minor reactions to sudden overwhelming reactions and can cause death. 18. Anesthetic Complications: Anesthesia used to put you to sleep for surgery can be associated with a variety of complications, including death. 19. Loss of Bodily Function: The loss of bodily function, Including stroke, heart attack, heart failure, kidney failure, limb loss, and other problems related to surgery or anesthesia, can occur. 20. Transfusion Risks: Although the blood and blood components that are administered are tested, there is still a small risk of acquiring infections including hepatitis and Acquired Immune Deficiency Syndrome (AIDS). 21. Hair Loss: Many patients develop hair loss for a period of time after the operation. This usually responds to increased intake of protein and vitamins. 22. Vitamin and Mineral Deficiencies: After Sleeve Gastrectomy, there may be decreased intake and absorption of many vitamins and minerals. Patients must take vitamin and mineral supplements forever, to protect themselves from these problems. 23. Vitamin and Mineral Deficiencies: Vitamin and mineral deficiencies can put the newborn babies of pregnant mothers at risk of permanent and irreversible damage. No pregnancy should occur for the first two years after the operation, and patients must be certain not to miss any of their vitamins if they decide to go ahead with pregnancy after that. 24. Skin problems: Lose skin may develop after weight loss, necessitating plastic surgery. Infections may occur in areas of skin folds. 25. Depression: Depression is a common medical Illness, and has been found to be particularly common in the first weeks after the operation. 26. Kidney Stones: Usually associated with dehydration, kidney stones can occur in any event after any Bariatric surgical procedure. 27. Gallbladder disease: Gallstones may form or motility problems of the gallbladder can occur after weight is lost. Specific medication that is given to you after surgery to decrease the risk of gall stone formation has to be taken for six months. 28. Laparoscopic Risks: Laparoscopic surgery uses punctures to enter the abdomen, and can lead to injury to abdominal contents, bleeding, & death. 29. Pancreatitis Inflammation: in the pancreas may occur after surgery. 30. Other Complications: Major abdominal surgery may be associated with a variety of other complications, both recognized and unrecognized. These may occur both soon or long after the operation. If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________

Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy

Unforeseen Complications, Conditions, or Results: I know that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantee has been made about the results that may be obtained from this procedure. I am aware that, in the practice of medicine, other unexpected problems, risks, or complications may occur. I also understand that, during the course of the proposed procedure, unforeseen conditions may be revealed, requiring the performance of additional procedures, and I authorize such procedures to be performed if deemed necessary by my surgeon. I further acknowledge that no guarantees or promises have been made to me concerning the results of any procedure or treatment. I understand that my sleeve gastrectomy may have to be converted to a gastric bypass if there is an unforeseen stapling problem or stenosis (narrowing of the sleeve). If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______.

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Comments:____________________________________________________________ Possibility of Conversion to Open Procedure: I realize that my surgeon plans to perform the operation laparoscopically, and that this approach has special risks, including injury to the abdominal contents such as blood vessels, the bowel, and other organs. Also, I realize that, in the event that the procedure cannot be completed laparoscopically, it will be completed if possible by way of the conventional open surgical approach. If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________ Alternatives to the Proposed Procedure: The available alternatives to Laparoscopic Sleeve Gastrectomy, some of which include open sleeve gastrectomy, laparoscopic oropen gastric bypass, vertical banded gastroplasty, biliopancreatic diversion with/without duodenal switch, laparoscopic gastric banding, various diets, exercise, and drug treatments have been explained and discussed in detail with me. The potential benefits and risks of the proposed Laparoscopic Sleeve Gastrectomy procedure, and the likely results with other treatments, have been discussed with me in detail. I understand what has been discussed with me, as well as the contents of this consent form, and I have been given the opportunity to ask questions, and have received satisfactory answers. If you agree that everything in the above paragraphs is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________

Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy

Information about General Anesthesia: A member of the anesthesia care team will visit you before your treatment/procedure to discuss the type of anesthesia you may need and to give you more information about anesthesia. It may become necessary to alter your anesthesia care plan after this discussion. Devices may be applied to your body and placed in your veins and arteries to monitor you during your anesthesia. All forms of anesthesia involve some risk. Minor (not life-threatening) risks include nausea, vomiting, and pain where an injection is given. Although rare, severe complications include injury to blood vessels, drug reactions, bleeding, blood clots, loss of sensation or limb function, infection, paralysis, stroke, brain damage, heart attack, and death. General Anesthesia involves drug being injected into the bloodstream or breathed into the lungs. A tube or other device may be inserted into your airway to help you breathe. The anticipated benefit is that you will be totally unconscious and you will not feel pain during the procedure. Additional risks include injury to the teeth, throat, eyes or lungs. In less than 1 case in 1,000, patients may be aware of the occurrences during their surgery. If you agree that everything in the above paragraph is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________ Long-term results: I understand that the sleeve gastectomy is a relatively new procedure. I understand that there is a lack of long-term data with regard to outcomes, risks, and resolution of medical problems. I understand that a second stage procedure may be required in the future if I fail to lose adequate weight or if I start to regain weight. I understand there is a chance that my sleeve will stretch (dilate) over time which could lead to weight regain and failure of weight loss. If you agree that everything in the above paragraph is correct, please check Yes ____ and initial here ______. Comments:____________________________________________________________

Consent for Treatment/Procedure Laparoscopic Sleeve Gastrectomy

Signatures: I. Practitioner: By signing below, I attest to the following:

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- All relevant aspects of the proposed procedure and its alternatives (including no treatment) have been discussed with the patient (or surrogate) in language that s/he could understand. This discussion included the nature, indications, benefits, risks, and likelihood of success of each option. - The patient (or surrogate) demonstrated comprehension of the discussion. - I have given the patient (or surrogate) an opportunity to ask questions. - I did not use threats, inducements, misleading information, or make any attempt to coerce the patient/surrogate to consent to this treatment/procedure. - I have offered the patient (or surrogate) the opportunity to review a printed copy of the consent form. ________________________ ______________________ Practitioner’s Signature Practitioner’s Name: ______/______/___________ ______________________ Date Time II. Patient (or Surrogate): By signing below, I attest to the following - My surgeon has explained this procedure, what it is intended for, and what would happen if I have no treatment/procedure. - My surgeon has explained how this treatment/procedure could help me, and what things could go wrong. - My surgeon has told me about other treatments/procedures. - My surgeons and his associates have answered all my questions - I know that I may refuse or change my mind about having this procedure. If I do refuse or change my mind, I will not lose my healthcare. - I have been offered the opportunity to read the consent form. - I choose to have this treatment/procedure voluntarily. ________________________ _______________________ Patient’s Signature Patient’s Name: ______/______/___________ _______________________ Date Time

V2-072010

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Regional Bariatrics A New Beginning  

Surgical guide for patients to start the path to surgery.

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