Band diet lap surgery
The claimed advantage of LASGB is the adjustability of the band, which can be inflated or deflated percutaneously according to weight loss without altering the anatomy of the stomach. Laparoscopic gastric plication was performed in 12 adolescents (9 females and 3 males). One non-randomized controlled clinical study that reported positive results reported that results were not maintained after gastric balloon removal (Ramhamadany et al, 1989). However, the assessment found that the profile of adverse events differs between the two approaches. It also found that VBG shows substantial weight loss efficacy but less than that for RYGB. , the VBLOC device, also known as the Maestro Implant or the Maestro Rechargeable System). 3 %, 55. Although the long-term effectiveness of weight reduction programs has been questioned, the Institute of Medicine (1995) has reported the substantial short-term effectiveness of certain organized physician-supervised weight reduction programs. The study also found that sleeve gastrectomy was associated with more severe complications than LASGB. Huang et al (2012) noted that the laparoscopic adjustable gastric band has been widely accepted as 1 of the safest bariatric procedures to treat morbid obesity. Thirty-four (97 %) of 35 patients who had undergone pre- and post-operative funduscopy were found to have resolution of papilledema post-operatively. It is associated with a minimal risk of leakage, bleeding, and nutritional deficiency. Oxidative stress was measured by concentration of hydroperoxides (CEOOH) in liver tissue. The authors recommended routine liver biopsy during bariatric operations to determine the prevalence and natural history of NASH, which will have important implications in directing future therapeutics for obese patients with NASH and for patients undergoing bariatric procedures. The negative predictive values from Group 1 liver biopsies for NASH and portal fibrosis were only 83 % and 67 %, respectively. Factors such as blood glucose control, hypertension, etc. They stated that additional prospective comparative trials and long-term follow-up are needed to further define the role of LGP in the surgical management of obesity. The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. Primary efficacy outcome was achieved by 22. Cazzo et al (2014) stated that non-alcoholic fatty liver disease (NAFLD) is common among subjects who undergo bariatric surgery and its post-surgical improvement has been reported. Prospective data on patients undergoing Roux-en-Y gastric bypass (RYGBP) was analyzed. Roux-en-Y Gastric Bypass (RYGB), Laparoscopic Adjustable Silicone Gastric Banding (LASGB), Sleeve Gastrectomy, Biliopancreatic Diversion (BPD) and Duodenal Switch (DS) Procedures. Surgery for obesity, termed bariatric surgery, includes gastric restrictive procedures and gastric bypass. This causes vomiting, which can tear out the staple line and destroy the operation. , RYGB), and restrictive procedures (e. The mean excess weight loss at 1, 3, 6, 9, and 12 months after surgery was 21. These included demographic data, pre- and post-operative symptoms, pre- and post-operative visual field deficits, bariatric procedure type, absolute weight loss, changes in BMI, and changes in cerebrospinal fluid (CSF) opening pressure. This team should include experienced surgeons and physicians, skilled nurses, specialty-educated nutritionists, experienced anesthesiologists, and, as needed, cardiologists, pulmonologists, rehabilitation therapists, and psychiatric staff. Smoking cessation reduces the risk of pulmonary complications from surgery. The process of digestion is more or less normal. Results of the morbidity, mortality and weight loss were presented. The results of the first cases where this technique has been applied in this hospital were presented. No restrictions were placed on these searches, including the date of publication. 1 % of the patients. ), an endoluminal fastener and delivery system used to tighten esophageal tissue. Ideally patients selected for surgery should have no major perioperative risk factors, a stable personality, no eating disorders, and have lost some weight prior to surgery. Brethauer et al (2011) presented the results of a feasibility study using laparoscopic gastric plication for weight loss achieved without stapling or banding. In addition, VBG has a high rate of serious morbidity, including a re-operation rate of up to 30 % from stoma obstruction and staple-line disruption. 3 % of their total body weight). BMI exceeding 40 with one or more of the following serious co-morbidities. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach. Weight reduction reduces the size of the liver, making surgical access to the stomach easier. It is not known whether the benefits of obesity surgery in children and adolescents outweigh the increased risks. The degree and histopathological discordance is dependent upon zonal location and types of injury. There is a lack of data on the durability of the results with the ReShape Integrated Dual Balloon System. Bariatric surgery as a treatment for idiopathic intracranial hypertension. Operative time ranged from 50 to 117. The evidence for the mini gastric bypass has come from a single investigator, thus raising questions about the generalization and validity of the reported findings. One patient required replication 4 days post-operatively due to obstruction at the site of the last knot. The intragastric balloon (also known as the silicone intragastric balloon or SIB) has been developed as a temporary aid for obese patients who have had unsatisfactory results in their clinical treatment for obesity and super obese patients with higher surgical (Fernandes et al, 2004). After institutional review board approval, 2 methods were used to achieve laparoscopic gastric volume reduction. Natural orifice transoral endoscopic surgery (NOTES) techniques for bariatric surgery including, but may not be limited to, the following. 7 %). However, because of variations in the results and the complications that tend to arise from port adjustment, alternative procedures are needed. The Task Group recommended to decide on a case-by-case basis whether to proceed with surgery in patients who are unable to lose weight. 4 % with follow-up from 6 months to 24 months. Fobi, is a modification of gastric bypass surgery. Liver biopsy remains the gold-standard for diagnosing NASH. 0 % versus 4. The Task Group recommended that smokers should be encouraged to stop, preferably at least 6 to 8 weeks before surgery (Saltzman et al, 2005). Vertical banded gastroplasty (VBG), a purely restrictive procedure, has fallen into disfavor because of inadequate long-term weight loss. 7 % versus 1. The aim of this study was to evaluate the role of liver oxidative stress in NAFLD affecting morbidly obese patients. In a prospective, single-center, randomized, single-blinded study, Eid et al (2014) examined the safety and effectiveness of endoscopic gastric plication with the StomaphyX device versus a sham procedure for revisional surgery in RYGB (performed at least 2 years earlier) patients to reduce regained weight. The assessment concluded that the evidence is not adequate to conclude that open or laparoscopic vertical banded gastroplasty is reasonable and necessary and they are therefore non-covered for all Medicare beneficiaries. Prevalence of NASH in bariatric patients is unknown. Note: The presence of depression due to obesity is not normally considered a contraindication to obesity surgery. The authors concluded that as previously reported by studies in which post-surgical biopsies were performed, RYGB leads to a great resolution rate of liver fibrosis. Moreover, following surgery, patients have to follow a careful diet of nutritious, high-fiber foods in order to avoid nutritional deficiencies, dumping syndrome, and other complications. Bariatric surgery as a treatment for type-2 diabetes in persons with a BMI less than 35. Fridley et al (2011) reviewed the literature on the effectiveness of bariatric surgery for obese patients with idiopathic intracranial hypertension (IIH) with regard to both symptom resolution and resolution of visual deficits. This study aimed to determine the evolution of liver disease evaluated through NAFLD fibrosis score 12 months after surgery. They stated that further prospective randomized studies with control groups and a larger number of participants are lacking within the published studies to date. Both groups had a similar prevalence of cirrhosis. However, distension of the pouch, slippage of the band and entrapment of the foreign material by the stomach have been described and are worrisome. An assessment of laparoscopic RYGB by the BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2005) stated that among available bariatric surgical procedures, RYGB appears to have the most favorable risk-to-benefit ratio, and that the overall risk-to-benefit ratio of laparoscopic RGBY is similar to that of open RGBY. Also, the stomach opening that leads into the intestines, which in surgery is made smaller to allow less food to pass through, often stretches as the years go by. Measured parameters included %EWL, percentage of BMI loss (%BMIL), obesity related co-morbidities, operative time, and length of hospitalization and complications. All of the published literature has been limited to descriptive articles, case series, and a prospective non-randomized controlled study. Pories et al (1995) reported 57. Available brands of LASGB include the Lap-Band System (Allergan, Inc. Biliopancreatic Diversion (BPD) (Jejunoilieal Bypass, Scorpinaro Procedure) and Duodenal Switch (DS) Procedures. In addition, the intragastric balloon has been associated with potentially severe adverse effects, including gastric erosion, reflux, and obstruction. The panel recommended the Roux-en-Y gastric bypass method of surgery over the simpler, newer technique of implanting an adjustable gastric band since gastric bands are less effective and younger patients would probably need replacement as they age. A total of 71 patients underwent sclerotherapy at their gastrojejunostomy from July 2004 to August 2006. 4 %). These researchers investigated the discordance of paired liver biopsies in individuals undergoing gastric bypass. The two groups were similar in age, gender, and BMI. For adults aged 18 years or older, presence of persistent severe obesity, documented in contemporaneous clinical records, defined as any of the following. Of the 6 patients who underwent GCP, the 6- and 12-month follow-up endoscopic examinations demonstrated a durable intraluminal fold, except for in 1 patient, with a partial disruption at the distal fold owing to a broken suture. Physician-supervised nutrition and exercise program: Member has participated in physician-supervised nutrition and exercise program (including dietician consultation, low calorie diet, increased physical activity, and behavioral modification), documented in the medical record at each visit. Bariatric Surgery for the Treatment of Idiopathic Intracranial Hypertension. In 13 patients both pre- and post-operative CSF pressures were recorded, with an average post-operative pressure decrease of 254 mm H(2)O. The CTAF assessment found few comparative studies of sleeve gastrectomy. These studies were from a single group of investigators, raising questions about the generalization of the findings. However, RYGB is associated with significantly more weight loss, and has become the procedure of choice for obesity surgery. When comparing patients in the 75th with those in the 25th percentile of pre-operative weight loss, the risk of complications was reduced by 13 %. , person meets the criteria for treatment of obstructive sleep apnea set forth in. It offered insight into an early time course for symptom resolution, and explored the impact of weight-loss surgery on migraine headaches. Although the basic concept of gastric bypass remains intact, numerous variations are being performed at this time. A decision memorandum from the Centers for Medicare and Medicaid Services (CMS, 2006) concluded that open or laparoscopic BPD with or without DS are reasonable and necessary for Medicare beneficiaries. Dramatic improvement in IIH headaches occurred by 4 months post-procedure and was maintained at 1 year, when she reached her weight plateau with a BMI of 35. Body Mass Index as a Criterion for Candidacy for Obesity Surgery. , Irvine, CA) and the Realize Adjustable Gastric Band (Ethicon Endo-Surgery, Cincinnati, OH). Sampling discordance was greatest for portal fibrosis (26 %), followed by zone 3 fibrosis (13 %) and ballooning degeneration (3 %). The average age of the patients was 45 years and all but 4 patients were women. The authors concluded that the published Class IV evidence suggested that bariatric surgery may be an effective treatment for IIH in obese patients, both in terms of symptom resolution and visual outcome. The Multidisciplinary Care Task Group recommended the use of patient selection criteria from the NIH Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity, which are consistent with those of other organizations. No mortality was reported in these studies and the rate of major complications requiring re-operation ranged from 0 % to 15. 2 pounds (3. The NIH Consensus Conference (1998) states that the combination of a reduced calorie diet and increased physical activity can result in substantial improvements in blood pressure, glucose tolerance, lipid profile, and cardiorespiratory fitness. Histology showed fatty liver in 92. A synthetic band is placed around the stomach opening to keep it from stretching. The most frequently found morbidity was nausea and vomiting. 4 days). Rationale for Six-Month Nutrition and Exercise Program Prior to Surgery. 0 % and 2. A total of 85 publications were identified, and after initial appraisal, 17 were included in the final review. 3 % versus 1. A number of studies have demonstrated a relationship between surgical volumes and outcomes of obesity surgery. Patients who have this operation must have lifelong medical follow-up, since the side effects can be subtle, and can appear months to years after the surgery. 4 % (1) with the sham procedure (p. The authors concluded that the results demonstrate that significant sampling variability exists in class 2 and 3 obese individuals undergoing screening liver biopsies for NAFLD. It is thought that these patients lose restriction because of the dilated gastrojejunostomy and thus overeat. The loop gastric bypass developed years ago has generally been abandoned by most bariatric surgeons as unsafe. A total of 11 relevant publications (including 6 individual case reports) were found, reporting on a total of 62 patients. 7 % with normal liver. These researchers planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year. Resolution was statistically associated with female gender, percentage of excess weight loss, post-surgical BMI, post-surgical platelet count, and diabetes resolution. For the 9 patients who underwent AP, the 6- and 12-month endoscopic evaluations demonstrated comparable-size plications over time, except for in 1 patient, who had a partially disrupted fold. Although easier to perform than the RYGB, it has been shown to create a severe hazard in the event of any leakage after surgery, and seriously increases the risk of ulcer forrmation, and irritation of the stomach pouch by bile. 3 and a 5-year history of severe headaches and moderate papilledema due to IIH. 7 %). The report stated that the incidence of gastric sleeve dilatation appears to be an uncommon event, but the evidence is far from conclusive at this point. The outlet of this pouch is restricted by a band of synthetic mesh, which slows its emptying, so that the person having it feels full after only a few bites of food. Reduced-calorie diet program supervised by dietician or nutritionist. Regarding performing adjustable gastric banding as an open procedure, the CMS decision memorandum (2006) concluded that the evidence is not adequate to conclude that open adjustable gastric banding is reasonable and necessary and therefore this procedure remains noncovered for Medicare beneficiaries. This device should not be used in patients who have had previous gastro-intestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H. Weight loss prior to surgery makes the procedure easier to perform. Handley et al (2015) systematically reviewed the effect of bariatric weight reduction surgery as a treatment for IIH. 9 cmH2 O in the 12 patients who had this recorded. Smoking cessation is especially important in obese persons, as obesity places them at increased risk for cardiovascular disease. , affect surgical risk. Intragastric balloon is intended to reduce gastric capacity, causing satiety, making it easier for patients to take smaller amounts of food. Therefore, the appropriateness of obesity surgery in non-compliant patients should be questioned. Aetna considers open or laparoscopic vertical banded gastroplasty (VBG) medically necessary for members who meet the selection criteria for obesity surgery and who are at increased risk of adverse consequences of a RYGB due to the presence of any of the following co-morbid medical conditions. The authors concluded that routine liver biopsy documented significant liver abnormalities in a larger group of patients compared with selective liver biopsies, thereby suggesting that liver appearance is not predictive of NASH. Eleven (92 %) of 12 patients who had undergone pre- and post-operative formal visual field testing had complete or nearly complete resolution of visual field deficits, and the remaining patient had stabilization of previously progressive vision loss. By contrast, the liver enlarges and becomes increasingly infiltrated with fat when weight is gained prior to surgery. The small bowel is then divided, and the end going to the cecum of the colon is connected to the short stump of the duodenum. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. A total of 242 patients underwent open and laparoscopic RYGBP from 1998 to 2001. 3 %, including 43. The Roux-en-Y gastric bypass was the most common bariatric procedure performed. Neither BMI nor liver enzymes predicted the presence or severity of NASH. Laparoscopic adjustable gastric banded plication was performed using 5-port surgery. 1 % versus 2. The authors concluded that this treatment modality should be further investigated prospectively to analyze the rate of headache improvement with weight loss, the amount of weight loss needed for clinical improvement, and the possible correlation with improvement in papilledema. The published literature was reviewed using manual and electronic search techniques. According to the recommendations by the expert panel, potential candidates for bariatric surgery should be referred to centers with multi-disciplinary weight management teams that have expertise in meeting the unique needs of overweight adolescents. Weight loss surgery patients need to learn important new skills, including self-monitoring and meal planning. A Multidisciplinary Care Task Group (Saltzman et al, 2005) conducted a systematic review of the literature to to provide evidence-based guidelines for patient selection and to recommend the medical and nutritional aspects of multi-disciplinary care required to minimize peri-operative and post-operative risks in patients with severe obesity who undergo weight loss surgery. The assessment found that open and laparoscopic RYGB induces similar amounts of weight loss. Fifty-six (92 %) of 61 patients with recorded post-operative clinical history had resolution of their presenting IIH symptoms following bariatric surgery. Laparoscopic RGBY had a higher rate of postoperative anastomotic leaks than open RGBY (3. The CTAF assessment reported that the results of multiple case series and retrospective studies have suggested that sleeve gastrectomy as a primary procedure is associated with a significant reduction in excess weight loss. BMI greater than 35 in conjunction with any of the following severe co-morbidities. The assessment noted that, due to limited evidence and poor quality of the trials comparing each pair of procedures, these conclusions should be viewed with caution. Surgery should only be performed at facilities that are equipped to collect long-term data on clinical outcomes. The 1st patient in the GCP group required re-operation and plication reduction owing to gastric obstruction. Aetna considers VBG experimental and investigational when medical necessity criteria are not met. They placed Swedish bands using the pars flaccida method, divided the greater omentum, and performed gastric plication below the band to 3 cm from the pylorus using a single-row continuous suture. This method entails encircling the upper part of the stomach using bands made of synthetic materials, creating a small upper pouch that empties into the lower stomach through a narrow, non-stretchable stoma. The Roux-en-Y modification of the loop bypass was designed to divert bile downstream, several feet below the gastric pouch and esophagus to minimize the risk of reflux. Clinically significant obstructive sleep apnea (i. Vagus nerve blocking (e. They must also be able to understand, and be adequately prepared for, potential complications. The nutrition and exercise program may be administered as part of the surgical preparative regimen, and participation in the nutrition and exercise program may be supervised by the surgeon who will perform the surgery or by some other physician. Hospital stay varied from 0. g. BMI exceeding 50 with one or more of the following less serious co-morbidities. More recently, a review of the literature by the Veterans Health Administration Technology Assessment Program (Adams, 2008) found no new literature that would not alter the conclusions of the ANZHSN review. Recent data demonstrate that surgeons are moving from simple gastroplasty procedures, favoring the more complex gastric bypass procedures as the surgical treatment of choice for the severely obese patient. The Task Group also noted that weight loss surgery is contraindicated in those who are unable to comprehend basic principles of weight loss surgery or follow operative instructions. 75 to 5 days (average of 2. Some have advocated use of the DS procedure in the super-obese (i. For maximal benefit, dieting should occur proximal to the time of surgery, and not in the remote past to reduce surgical risks and improve outcomes. A randomized controlled clinical trial comparing short-term (1-year) outcomes of laparoscopic sleeve gastrectomy to laparoscopic RYGB found comparable reductions in body weight and BMI (Karamanakos et al, 2008). This new device is intended to facilitate weight loss in obese adult patients by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood. Roux-en-Y Gastric Bypass (RYGB) and Vertical Banded Gastroplasty (VBG).
NASH was defined as steatohepatitis without alcoholic or viral hepatitis. g. , adjustable gastric banding) result in the least amounts of weight loss. For these reasons, it is therefore best for patients to develop good eating and exercise habits before they undergo surgery. The patient may be able to lose significant weight prior to surgery in order to improve the outcome of surgery. The pre-operative surgical preparatory regimen should include cessation counseling for smokers. Garza (2003) explained that the patient should lose weight prior to surgery to reduce surgical risks. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. Both patients were at a high risk and could not undergo another open or laparoscopic surgery to correct the leaks that were not healing. 9 %), and a somewhat higher rate of bleeding (4. There is rarely a good reason why obese patients (even super obese patients) can not delay surgery in order to undergo behavioral modification to improve their dietary and exercise habits in order to reduce surgical risks and improve surgical outcomes. Ji et al (2014) conducted a systematic review of the currently available literature regarding the outcomes of laparoscopic gastric plication (LGP) for the treatment of obesity. g. The data were collected and analyzed pre- and post-operatively. Prevalence of NASH was 26 % in Group 1 and 32 % in Group 2. The authors concluded that laparoscopic gastric plication is a new surgical technique which gives equivalent short-term results as vertical gastrectomy. It is unclear what benefit there is from a temporary reduction in weight. Data from each relevant manuscript were gathered, analyzed, and compared. There is active collaboration with multiple patient care disciplines including nutrition, anesthesiology, cardiology, pulmonary medicine, orthopedic surgery, diabetology, psychiatry, and rehabilitation medicine. The gastric restrictive procedures include vertical banded gastroplasty accompanied by gastric banding which attempt to induce weight loss by creating an intake-limiting gastric pouch by segmenting the stomach along its vertical axis. The modifications to gastric bypass surgery are designed to prevent post-surgical enlargement of the gastric pouch and stoma. If you are on a personal connection, like at home, you can run an anti-virus scan on your device to make sure it is not infected with malware. These investigators presented a case report of a 29-year old female with a maximum BMI of 50. Pujol Gebelli et al (20110 stated that laparoscopic gastric plication is a new technique derived from sleeve gastrectomy. Oliveira et al (2005) stated that pathogenesis of non-alcoholic fatty liver disease (NAFLD) remains incompletely known, and oxidative stress is one of the mechanisms incriminated. As a high incidence of gallbladder disease (28 %) has been documented after surgery for morbid obesity, Aetna considers routine cholecystectomy medically necessary when performed in concert with elective bariatric procedures. The assessment found that the estimated mortality rate was low for both procedures, but somewhat lower for laparoscopic surgery than open surgery (0. e. These investigators enrolled 26 patients from May 2009 to August 2010. Furthermore, an improvement was observed in patients where conventional treatments, including neurosurgery, were ineffective. The authors concluded that bariatric surgery for weight loss is associated with alleviation of IIH symptoms and a reduction in intracranial pressure. Plication of the greater curvature produces a restrictive mechanism that causes weight loss. In 2008, Loewen and Barba evaluated the injection of morrhuate sodium as sclerotherapy to decrease the diameter of the gastrojejunostomy anastomosis following gastric bypass. The greater and lesser curvatures were approximated to create an intraluminal fold of the stomach. After a waxing and waning course and various medical treatments, the patient underwent laparoscopic Roux-en-Y gastric bypass surgery with anterior repair of hiatal hernia. However, they stated that large well-designed studies with long-term follow-up are needed. 9 mins (average of 79. , persons with BMI greater than 50) because of the substantial weight loss induced by this procedure. If this goal is achieved, further weight loss can be attempted, if indicated through further evaluation. These procedures are not for cosmesis but for prevention of the pathologic consequences of morbid obesity. Gastric bypass surgery has been used to treat morbid obesity and its co-morbidities, and IIH has recently been considered among these indications. Requirement for Physician Supervision of Program Documented in Medical Record. A fatty liver is heavy, brittle, and more likely to suffer injury during surgery. , San Clemente, CA) to treat obesity without the need for invasive surgery. 6 % with NASH, 48. Australia has reported that the costs of band adjustments with LASGB has exceeded the costs of the primary LASGB procedure. It is meant to be temporary and should be removed 6 months after it is inserted. 3 pounds they lost. Some Aetna plans entirely exclude coverage of surgical treatment of obesity. Laparoscopic RYGB is a less invasive approach that results in a shorter hospital stay and earlier return to usual activities. There is established evidence that medical supervision of a nutrition and exercise program increases the likelihood of success (Blackburn, 1993). The primary efficacy end-point was reduction in pre-RYGB excess weight by 15 % or more excess BMI (calculated as weight in kilograms divided by height in meters squared) loss and BMI less than 35 at 12 months after the procedure. Two complications developed: (i) gastrogastric intussusception and (ii) tube kinking at the subcutaneous layer. Children and adolescents are rapidly growing, and are therefore especially susceptible to adverse long-term consequences of nutritional deficiencies from the reduced nutrient intake and malabsorption that is induced by obesity surgery. Aetna considers open or laparoscopic short or long-limb Roux-en-Y gastric bypass (RYGB), open or laparoscopic sleeve gastrectomy, open or laparoscopic biliopancreatic diversion (BPD) with or without duodenal switch (DS), or laparoscopic adjustable silicone gastric banding (LASGB) medically necessary when the selection criteria listed below are met. Because the normal flow of food is disrupted, available literature indicates that there is a greater potential for metabolic complications compared to gastric restrictive surgeries, including iron deficiency anemia, vitamin B-12 deficiency and hypocalcemia, all of which can be corrected by oral supplementation. If you are at an office or shared network, you can ask the network administrator to run a scan across the network looking for misconfigured or infected devices. Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9. The reduced capacity of the pouch and the restriction caused by the band diminish caloric intake, depending on important technical details, thus producing weight loss comparable to vertical gastroplasties, without the possibility of staple-line disruption and lesser incidence of infectious complications. A decision memorandum from the Centers for Medicare and Medicaid Services (CMS, 2006) concluded that the evidence is sufficient that open and laparoscopic RYGB is reasonable and necessary for Medicare beneficiaries who have a BMI greater than 35 and have at least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity. , biliopancreatic diversion (BPD)) result in the greatest amounts of weight loss, hybrid procedures are of intermediate effectiveness (e. The early weight loss results have been encouraging, with better weight loss in patients who underwent GCP. Plication of the gastric greater curvature was performed under general anesthetic and by laparoscopy using 3 lines of sutures and with an orogastric probe as a guide. The other end, leading from the gallbladder and pancreatic ducts, is connected onto the enteral limb at about 75 to 100 cm from the iliocecal valve. Obesity surgery is not indicated for persons with transient increases in weight (Collazo-Clavell, 1999). 7 % with isolated steatosis and just 7. 0 % versus 0 %). The technique is safe, feasible, and reproducible and can be used as an alternative bariatric procedure. One pathologist graded all liver biopsies as mild, moderate or severe steatohepatitis. 2 % excess weight loss with RYGB at 5, 10, and 14 years, respectively, in a large series with 95 % follow-up. 5 %, respectively. The CMS decision memorandum found that short-and-long-term mortality associated with both LASGB and RYGB were low (less than 2 %) in this younger age group. The mini-gastric bypass uses a jejunal loop directly connected to a small gastric pouch, instead of a Roux-en-Y anastomosis. Nevertheless, a 25-mm biopsy specimen without zone 3 cellular ballooning or fibrosis appears adequate to exclude the diagnosis of NASH. Levin and colleagues (2015) stated that IIH occurs most frequently in young, obese women. CPB 0039 - Weight Reduction Medications and Programs. The total weight loss from surgery can be enhanced if it is combined with a low-calorie diet. L. Arun et al (2007) stated that NAFLD is a chronic condition that can progress to cirrhosis and hepatocellular cancer. The Task Group stated that registered dietitians are best qualified to provide nutritional care, including pre-operative assessment and nutritional education and counseling. Overall improvement in symptoms of IIH after bariatric surgery was observed in 60 of the 65 patients observed (92 %). Procedures that are mainly diversionary (e. The BPD was designed to address some of the drawbacks of the original intestinal bypass procedures, which resulted in unacceptable metabolic complications of diarrhea, hyperoxaluria, nephrolithiasis, cholelithiasis and liver failure. In a sense, this procedure combines the least desirable features of the gastric bypass with the most troublesome aspects of the biliopancreatic diversion. Peri-operative data were collected from each study and recorded. Even if the patient has not been able to keep weight off long-term with prior dieting, the patient may be able to lose significant weight short term prior to surgery in order to improve the outcome of surgery. The percentage of EWL (% EWL) for LGP varied from 31. 0 %, respectively), while the rate of incisional hernia is higher for open RGBY than laparoscopic RGBY (9. Findings of cirrhosis on frozen section changed the operation from a distal to a proximal RYGBP. These investigators performed a comprehensive literature search using the following databases: MEDLINE, EMBASE, PubMed, Scopus, Web of Sciences, and the Cochrane Library. A Multidisciplinary Care Task Group (Saltzman et al, 2005) recommended that operative candidates must be committed to the appropriate work-up for the procedure and to continued long-term post-operative medical management. Severely obese persons are at increased risk of surgical complications. A problem with the traditional procedure is that the staples can break down, causing the stomach to regain its original shape -- and patients to start gaining weight again. They stated that prospective, controlled studies are needed for better elucidation of its role. The duodenum is divided just beyond the pylorus. Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end-point in at least 50 % of StomaphyX-treated patients. 9 %) and anastomotic problems (8. Anderin et al (2015) found that weight loss before bariatric surgery is associated with marked reduction of risk of postoperative complications. The authors concluded that LGP has the potential of being an ideal weight loss surgery for adolescents, resulting in excellent weight loss and minimal psychological disruption. The Task Group stated that registered dietitians are best qualified to provide nutritional care, including pre-operative assessment and post-operative education, counseling, and follow-up. 2 %, and 59. This physician-supervised nutrition and exercise program must meet all of the following criteria. The gastric bypass operation can be modified, to alter absorption of food, by moving the Roux-en-Y-connection distally down the jejunum, effectively shortening the bowel available for absorption of food. 2 % (10) with StomaphyX versus 3. Changes in weight loss and BMI varied depending on the reported post-operative follow-up interval. In a prospective study, Zeinoddini (2014) evaluated safety and effectiveness of LGP on adolescents. 3 mins without any intra-operative complications. The patient must be committed to the appropriate work-up for the procedure and for continuing long-term postoperative medical management, and understand and be adequately prepared for the potential complications of the procedure. Although patients can have increased frequency of bowel movements, increased fat in their stools, and impaired absorption of vitamins, recent studies have reported good results. Roux-en-Y gastric bypass as a treatment for gastroesophageal reflux in non-obese persons. Candidates for obesity surgery should begin a weight reduction diet prior to surgery. Overall, clinical studies have shown that about 40 % of persons who have this operation do not achieve loss of more than half of their excess body weight. It is a prospective cohort study which evaluated patients immediately before and 12 months following Roux-en-Y gastric bypass (RYGB). The group with the routine liver biopsies showed a statistically significant larger preponderance of NASH (37 % versus 32 %). According to the available literature, patients who have this procedure seldom experience any satisfaction from eating, and tend to seek ways to get around the operation by eating more. Most recently, an assessment by the Canadian Agency for Drugs and Technologies in Health (CADTH) (Klarenbach et al, 2010) stated that their volume-outcome review found that higher surgical volumes were associated with better clinical outcomes. This added to the small number of case reports and retrospective analyses of the successful treatment of IIH with gastric bypass surgery, and brought this data from the surgical literature into the neurological domain. Post-operative lumbar puncture opening pressure was shown to decrease by an average of 18. The aim of this study was to determine the role of routine liver biopsy in managing bariatric patients. 4 % (average of 3. For patients in the highest range of body mass index (BMI), the risk reduction associated with pre-operative weight loss was statistically significant for all analyzed complications, whereas corresponding risk reductions were only occasionally encountered and less pronounced in patients with lower BMI. Complications were noted in 9. Similarly, however, less pronounced risk reductions were found when comparing patients in the 50th with those in the 25th percentile of pre-operative weight loss. g. Completing the CAPTCHA proves you are a human and gives you temporary access to the web property. Aetna considers surgery to correct complications from bariatric surgery medically necessary, such as obstruction, stricture, erosion, or band slippage. This study was poorly reported, failing to discuss inclusion criteria for the trial and adverse events associated with the procedures. The weight loss effect is then a combination of the very small stomach, which limits intake of food, with malabsorption of the nutrients, which are eaten, reducing caloric intake even further. Liver cirrhosis was present in 11. Gentileschi et al (2002) systematically reviewed the published literature on open and bariatric laparoscopic obesity surgery and concluded that the available evidence indicates that laparoscopic VBG and laparoscopic RYGB are as effective as their open counterparts. Shalhub et al (2004) noted that non-alcoholic steatohepatitis (NASH) commonly occurs in obese patients and predisposes to cirrhosis. 6 % versus 1. On July 28, 2015, the Food and Drug administration (FDA) approved the ReShape Integrated Dual Balloon System (ReShape Medical Inc. The report found, on the other hand, that open surgery had higher rates of cardiopulmonary complications (2. The authors concluded that laparoscopic adjustable gastric banded plication provides both restrictive and reductive effects and is reversible. CADTH was not, however, able to identify specific thresholds for surgical volume that were associated with better clinical outcomes. Aetna considers each of the following procedures experimental and investigational because the peer-reviewed medical literature shows them to be either unsafe or inadequately studied. Given the importance of patient compliance in diet and self-care in improving patient outcomes after surgery, the appropriateness of obesity surgery in noncompliant patients should be questioned. The authors concluded that early reports with LGP were promising with a favorable short-term safety profile. Specifically, performing a loop, rather than a Roux-en-Y, anastomosis to a small gastric pouch in the stomach may permit reflux of bile and digestive juice into the esophagus where it can cause esophagitis and ulceration, and may thus increase the risk of esophageal cancer. 8 % of their total body weight) when the device was removed at 6 months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7. However, it remains unclear if weight loss following LGP is durable in the long-term. 9 %, 31. Consecutive liver biopsies were compared to those liver biopsies selected because of grossly fatty livers. Therefore, the evidence supports the overall superiority of RYGB over VBG in safety and efficacy for bariatric surgery. 8 % to 74. In March 2007, the FDA granted 510(k) pre-marketing clearance to the StomaphyX (EndoGastric Solutions, Inc. 7 % of those with NASH. A total of 13 patients were operated on (7 women). The Task Group also recommended a pre-operative assessment for micronutrient deficiencies. 0 %) and wound infections (11. 7 %, and 49. The trend towards use of Roux-en-Y and away from loop gastric bypass was based on sound surgical experience of multiple surgeons with large series of patients. A retrospective review was performed of this group, including chart review, follow-up data with weight checks, and telephone interview findings. Dedicated dietitians can help patients during their pre-operative education on new dietary requirements and stipulations and their post-surgical adjustment to those requirements. The Fobi pouch, developed by California surgeon Mathias A. 0 %) may be higher for laparoscopic RGBY than for open RGBY (6. 3 pounds on average (6. Since post-surgical biopsy is not widely available and has a significant risk, calculation of NAFLD fibrosis score is a simple tool to evaluate this evolution through a non-invasive approach. Many forms of weight loss surgery require patients to take lifelong nutritional supplements and to have lifelong medical monitoring. Studies have reported that many patients must undergo another revisional operation to obtain the results they seek. 1 %). The National Institutes of Health Consensus Statement (1998) states that all smokers should be encouraged to quit, regardless of weight. It is a reproducible and reversible technique with results and indications still to be validated. While appropriate surgical procedures for severe obesity primarily produce weight loss by restricting intake, intestinal bypass procedures produce weight loss by inducing a malabsorptive effect. Note: Most Aetna HMO and QPOS plans exclude coverage of surgical operations, procedures or treatment of obesity unless approved by Aetna. 7 %, 54. The patient must be committed to the appropriate work-up for the procedure and for continuing long-term post-operative medical management, and must understand and be adequately prepared for the potential complications of the procedure. The mini-gastric bypass has not been subjected to a prospective clinical outcome study in peer-reviewed publication. 9 pounds of the 14. Recent advances in laparoscopy have renewed the interest in gastric banding techniques for the control of severe obesity. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group. Obesity makes many types of surgery more technically difficult to perform and hazardous. 2 mins). Patients should be encouraged to remain non-smokers after weight loss surgery to reduce the negative long-term health effects of smoking. In the study (Ponce et al, 2015), 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14. It is often the first step in a 2-stage procedure when performing RYGB or duodenal switch. Regarding long-term adverse events, the rates of reoperation (9. The most progressive form of NAFLD is NASH. e. In a traditional gastric bypass procedure, surgeons create a smaller stomach by stapling off a large section. An assessment by the Institute for Clinical Systems Improvement (ICSI, 2005) found that large studies have shown that RYGB may result in weight loss of 60 % to 70 % of excess weight. 9 %, 41. The American College of Surgeons (ACS) has stated that the surgeon performing the bariatric surgery be committed to the multidisciplinary management of the patient, both before and after surgery. The mean operative time was 87. Ideally, the surgical center where surgery is to be performed should be accomplished in bariatric surgery with a demonstrated commitment to provide adequate facilities and equipment, as well as a properly trained and funded appropriate bariatric surgery support staff. Minimal standards in these areas are set by the institution and maintained under the direction of a qualified surgeon who is in charge of an experienced and comprehensive bariatric surgery team. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.
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