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1.  Metabolic Effects of Bariatric Surgery in Patients With Moderate Obesity and Type 2 Diabetes 
Diabetes Care  2013;36(8):2175-2182.
OBJECTIVE
To evaluate the effects of two bariatric procedures versus intensive medical therapy (IMT) on β-cell function and body composition.
RESEARCH DESIGN AND METHODS
This was a prospective, randomized, controlled trial of 60 subjects with uncontrolled type 2 diabetes (HbA1c 9.7 ± 1%) and moderate obesity (BMI 36 ± 2 kg/m2) randomized to IMT alone, IMT plus Roux-en-Y gastric bypass, or IMT plus sleeve gastrectomy. Assessment of β-cell function (mixed-meal tolerance testing) and body composition was performed at baseline and 12 and 24 months.
RESULTS
Glycemic control improved in all three groups at 24 months (N = 54), with a mean HbA1c of 6.7 ± 1.2% for gastric bypass, 7.1 ± 0.8% for sleeve gastrectomy, and 8.4 ± 2.3% for IMT (P < 0.05 for each surgical group versus IMT). Reduction in body fat was similar for both surgery groups, with greater absolute reduction in truncal fat in gastric bypass versus sleeve gastrectomy (−16 vs. −10%; P = 0.04). Insulin sensitivity increased significantly from baseline in gastric bypass (2.7-fold; P = 0.004) and did not change in sleeve gastrectomy or IMT. β-Cell function (oral disposition index) increased 5.8-fold in gastric bypass from baseline, was markedly greater than IMT (P = 0.001), and was not different between sleeve gastrectomy versus IMT (P = 0.30). At 24 months, β-cell function inversely correlated with truncal fat and prandial free fatty acid levels.
CONCLUSIONS
Bariatric surgery provides durable glycemic control compared with intensive medical therapy at 2 years. Despite similar weight loss as sleeve gastrectomy, gastric bypass uniquely restores pancreatic β-cell function and reduces truncal fat, thus reversing the core defects in diabetes.
doi:10.2337/dc12-1596
PMCID: PMC3714483  PMID: 23439632
2.  Bariatric Surgery 
Executive Summary
Objective
To conduct an evidence-based analysis of the effectiveness and cost-effectiveness of bariatric surgery.
Background
Obesity is defined as a body mass index (BMI) of at last 30 kg/m2.1 Morbid obesity is defined as a BMI of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions. Comorbid conditions associated with obesity include diabetes, hypertension, dyslipidemias, obstructive sleep apnea, weight-related arthropathies, and stress urinary incontinence. It is also associated with depression, and cancers of the breast, uterus, prostate, and colon, and is an independent risk factor for cardiovascular disease.
Obesity is also associated with higher all-cause mortality at any age, even after adjusting for potential confounding factors like smoking. A person with a BMI of 30 kg/m2 has about a 50% higher risk of dying than does someone with a healthy BMI. The risk more than doubles at a BMI of 35 kg/m2. An expert estimated that about 160,000 people are morbidly obese in Ontario. In the United States, the prevalence of morbid obesity is 4.7% (1999–2000).
In Ontario, the 2004 Chief Medical Officer of Health Report said that in 2003, almost one-half of Ontario adults were overweight (BMI 25–29.9 kg/m2) or obese (BMI ≥ 30 kg/m2). About 57% of Ontario men and 42% of Ontario women were overweight or obese. The proportion of the population that was overweight or obese increased gradually from 44% in 1990 to 49% in 2000, and it appears to have stabilized at 49% in 2003. The report also noted that the tendency to be overweight and obese increases with age up to 64 years. BMI should be used cautiously for people aged 65 years and older, because the “normal” range may begin at slightly above 18.5 kg/m2 and extend into the “overweight” range.
The Chief Medical Officer of Health cautioned that these data may underestimate the true extent of the problem, because they were based on self reports, and people tend to over-report their height and under-report their weight. The actual number of Ontario adults who are overweight or obese may be higher.
Diet, exercise, and behavioural therapy are used to help people lose weight. The goals of behavioural therapy are to identify, monitor, and alter behaviour that does not help weight loss. Techniques include self-monitoring of eating habits and physical activity, stress management, stimulus control, problem solving, cognitive restructuring, contingency management, and identifying and using social support. Relapse, when people resume old, unhealthy behaviour and then regain the weight, can be problematic.
Drugs (including gastrointestinal lipase inhibitors, serotonin norepinephrine reuptake inhibitors, and appetite suppressants) may be used if behavioural interventions fail. However, estimates of efficacy may be confounded by high rates of noncompliance, in part owing to the side effects of the drugs. In addition, the drugs have not been approved for indefinite use, despite the chronic nature of obesity.
The Technology
Morbidly obese people may be eligible for bariatric surgery. Bariatric surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management, such as diet, increased physical activity, behavioural modification, and drugs.
There are various bariatric surgical procedures and several different variations for each of these procedures. The surgical interventions can be divided into 2 general types: malabsorptive (bypassing parts of the gastrointestinal tract to limit the absorption of food), and restrictive (decreasing the size of the stomach so that the patient is satiated with less food). All of these may be performed as either open surgery or laparoscopically. An example of a malabsorptive technique is Roux-en-Y gastric bypass (RYGB). Examples of restrictive techniques are vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB).
The Ontario Health Insurance Plan (OHIP) Schedule of Benefits for Physician Services includes fee code “S120 gastric bypass or partition, for morbid obesity” as an insured service. The term gastric bypass is a general term that encompasses a variety of surgical methods, all of which involve reconfiguring the digestive system. The term gastric bypass does not include AGB. The number of gastric bypass procedures funded and done in Ontario, and funded as actual out-of-country approvals,2 is shown below.
Number of Gastric Bypass Procedures by Fiscal Year: Ontario and Actual Out-of-Country (OOC) Approvals
Data from Provider Services, MOHLTC
Courtesy of Provider Services, Ministry of Health and Long Term Care
Review Strategy
The Medical Advisory Secretariat reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of bariatric surgery to treat morbid obesity. It used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases. The interventions of interest were bariatric surgery and, for the controls, either optimal conventional management or another type of bariatric procedure. The outcomes of interest were improvement in comorbid conditions (e.g., diabetes, hypertension); short- and long-term weight loss; quality of life; adverse effects; and economic analysis data. The databases yielded 15 international health technology assessments or systematic reviews on bariatric surgery.
Subsequently, the Medical Advisory Secretariat searched MEDLINE and EMBASE from April 2004 to December 2004, after the search cut-off date of April, 2004, for the most recent systematic reviews on bariatric surgery. Ten studies met the inclusion criteria. One of those 10 was the Swedish Obese Subjects study, which started as a registry and intervention study, and then published findings on people who had been enrolled for at least 2 years or at least 10 years. In addition to the literature review of economic analysis data, the Medical Advisory Secretariat also did an Ontario-based economic analysis.
Summary of Findings
Bariatric surgery generally is effective for sustained weight loss of about 16% for people with BMIs of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions (including diabetes, high lipid levels, and hypertension). It also is effective at resolving the associated comorbid conditions. This conclusion is largely based on level 3a evidence from the prospectively designed Swedish Obese Subjects study, which recently published 10-year outcomes for patients who had bariatric surgery compared with patients who received nonsurgical treatment. (1)
Regarding specific procedures, there is evidence that malabsorptive techniques are better than other banding techniques for weight loss and resolution of comorbid illnesses. However, there are no published prospective, long-term, direct comparisons of these techniques available.
Surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management, such as diet, increased physical activity, behavioural modification, and drugs. In the absence of direct comparisons of active nonsurgical intervention via caloric restriction with bariatric techniques, the following observations are made:
A recent systematic review examining the efficacy of major commercial and organized self-help weight loss programs in the United States concluded that the evidence to support the use of such programs was suboptimal, except for one trial on Weight Watchers. Furthermore, the programs were associated with high costs, attrition rates, and probability of regaining at least 50% of the lost weight in 1 to 2 years. (2)
A recent randomized controlled trial reported 1-year outcomes comparing weight loss and metabolic changes in severely obese patients assigned to either a low-carbohydrate diet or a conventional weight loss diet. At 1 year, weight loss was similar for patients in each group (mean, 2–5 kg). There was a favourable effect on triglyceride levels and glycemic control in the low-carbohydrate diet group. (3)
A decision-analysis model showed bariatric surgery results in increased life expectancy in morbidly obese patients when compared to diet and exercise. (4)
A cost-effectiveness model showed bariatric surgery is cost-effective relative to nonsurgical management. (5)
Extrapolating from 2003 data from the United States, Ontario would likely need to do 3,500 bariatric surgeries per year. It currently does 508 per year, including out-of-country surgeries.
PMCID: PMC3382415  PMID: 23074460
3.  Bariatric surgery and diabetes remission: Sleeve gastrectomy or mini-gastric bypass? 
AIM: To investigate the weight loss and glycemic control status [blood glucose, hemoglobin A1c (HbA1c) and hypoglycaemic treatment].
METHODS: The primary risk factor for type 2 diabetes is obesity, and 90% of all patients with type 2 diabetes are overweight or obese. Although a remarkable effect of bariatric surgery is the profound and durable resolution of type 2 diabetes clinical manifestations, little is known about the difference among various weight loss surgical procedures on diabetes remission. Data from patients referred during a 3-year period (from January 2009 to December 2011) to the University of Naples “Federico II” diagnosed with obesity and diabetes were retrieved from a prospective database. The patients were split into two groups according to the surgical intervention performed [sleeve gastrectomy (SG) and mini-gastric bypass (MGB)]. Weight loss and glycemic control status (blood glucose, HbA1c and hypoglycaemic treatment) were evaluated.
RESULTS: A total of 53 subjects who underwent sleeve gastrectomy or mini-gastric bypass for obesity and diabetes were screened for the inclusion in this study. Of these, 4 subjects were excluded because of surgical complications, 7 subjects were omitted because young surgeons conducted the operations and 11 subjects were removed because of the lack of follow-up. Thirty-one obese patients were recruited for this study. A total of 15 subjects underwent SG (48.4%), and 16 underwent MGB (51.6%). After adjusting for various clinical and demographic characteristics in a multivariate logistic regression analysis, high hemoglobin A1c was determined to be a negative predictor of diabetes remission at 12 mo (OR = 0.366, 95%CI: 0.152-0.884). Using the same regression model, MGB showed a clear trend toward higher diabetes remission rates relative to SG (OR = 3.780, 95%CI: 0.961-14.872).
CONCLUSION: Although our results are encouraging regarding the effectiveness of mini-gastric bypass on diabetes remission, further studies are needed to provide definitive conclusions in selecting the ideal procedure for diabetes remission.
doi:10.3748/wjg.v19.i39.6590
PMCID: PMC3801373  PMID: 24151386
Bariatric surgery; Sleeve; Bypass; Obesity and diabetes
4.  Can Diabetes Be Surgically Cured? 
Annals of surgery  2013;258(4):628-637.
Objective
Evaluate the long-term effects of bariatric surgery on type 2 diabetes (T2DM) remission and metabolic risk factors.
Background
Although the impressive antidiabetic effects of bariatric surgery have been shown in short- and medium-term studies, the durability of these effects is uncertain. Specifically, long-term remission rates following bariatric surgery are largely unknown.
Methods
Clinical outcomes of 217 patients with T2DM who underwent bariatric surgery between 2004 and 2007 and had at least 5-year follow-up were assessed. Complete remission was defined as glycated hemoglobin (A1C) less than 6% and fasting blood glucose (FBG) less than 100 mg/dL off diabetic medications. Changes in other metabolic comorbidities, including hypertension, dyslipidemia, and diabetic nephropathy, were assessed.
Results
At a median follow-up of 6 years (range: 5–9) after surgery (Roux-en-Y gastric bypass, n = 162; gastric banding, n = 32; sleeve gastrectomy, n = 23), a mean excess weight loss (EWL) of 55% was associated with mean reductions in A1C from 7.5% ± 1.5% to 6.5% ± 1.2% (P < 0.001) and FBG from 155.9 ± 59.5 mg/dL to 114.8 ± 40.2 mg/dL (P < 0.001). Long-term complete and partial remission rates were 24% and 26%, respectively, whereas 34% improved (>1% decrease in A1C without remission) from baseline and 16% remained unchanged. Shorter duration of T2DM (P < 0.001) and higher long-term EWL (P = 0.006) predicted long-term remission. Recurrence of T2DM after initial remission occurred in 19% and was associated with longer duration of T2DM (P = 0.03), less EWL (P = 0.02), and weight regain (P = 0.015). Long-term control rates of low high-density lipoprotein, high low-density lipoprotein, high triglyceridemia, and hypertension were 73%, 72%, 80%, and 62%, respectively. Diabetic nephropathy regressed (53%) or stabilized (47%).
Conclusions
Bariatric surgery can induce a significant and sustainable remission and improvement of T2DM and other metabolic risk factors in severely obese patients. Surgical intervention within 5 years of diagnosis is associated with a high rate of long-term remission.
doi:10.1097/SLA.0b013e3182a5034b
PMCID: PMC4110959  PMID: 24018646
bariatric; diabetes; gastric banding; gastric bypass; LAGB; long term; metabolic; nephropathy; RYGB; sleeve gastrectomy
5.  Obesity in adults 
Clinical Evidence  2010;2010:0604.
Introduction
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, cardiovascular disease, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years. Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments in adults with obesity? What are the effects of bariatric surgery in adults with morbid obesity? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 34 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: bariatric surgery versus medical interventions; biliopancreatic diversion; diethylpropion; gastric bypass; gastric banding; mazindol; orlistat (alone and in combination with sibutramine); phentermine; rimonabant; sibutramine (alone and in combination with orlistat); sleeve gastrectomy; and vertical banded gastroplasty.
Key Points
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, CVD, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years.Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Orlistat, phentermine, rimonabant, and sibutramine may promote modest weight loss (an additional 1-7 kg lost) compared with placebo in obese adults having lifestyle interventions, but they can all cause adverse effects. Sibutramine may be more effective at promoting weight loss compared with orlistat, although not in obese people with type 2 diabetes or hypertension.We don't know whether combining orlistat and sibutramine treatment leads to greater weight loss than with either treatment alone.We don't know whether diethylpropion and mazindol are effective at promoting weight loss in people with obesity.Orlistat has been associated with GI adverse effects.Phentermine has been associated with heart and lung problems.Sibutramine has been associated with cardiac arrhythmias and cardiac arrest. In January 2010, the European Medicines Agency suspended marketing authorisation of sibutramine in the European Union because of the increased risk of non-fatal myocardial infarctions and strokes.Rimonabant has been associated with an increased risk of psychiatric disorders.
Bariatric surgery (gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding) may increase weight loss compared with no surgery in people with morbid obesity.
Compared with each other, we don't know whether gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding is the most effective surgery or the least harmful. We don't know whether sleeve gastrectomy is effective. Bariatric surgery may result in loss of over 20% of body weight, which may be largely maintained for 10 years.Operative and postoperative complications are common, and on average 0.28% of people die within 30 days of surgery. Mortality may be as high as 2% in some high-risk populations. However, surgery may reduce long-term mortality compared with no surgery.
PMCID: PMC2907622
6.  Obesity in adults 
Clinical Evidence  2011;2011:0604.
Introduction
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, cardiovascular disease, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years. Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments in adults with obesity? What are the effects of bariatric surgery in adults with morbid obesity? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 39 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: bariatric surgery versus medical interventions, biliopancreatic diversion, diethylpropion, gastric bypass, gastric banding, mazindol, orlistat (alone and in combination with sibutramine), phentermine, sibutramine (alone and in combination with orlistat), sleeve gastrectomy, and vertical banded gastroplasty.
Key Points
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, CVD, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years.Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Orlistat, phentermine, and sibutramine may promote modest weight loss (an additional 1–7 kg lost) compared with placebo in obese adults having lifestyle interventions, but they can all cause adverse effects. Sibutramine may be more effective at promoting weight loss compared with orlistat, although not in obese people with type 2 diabetes or hypertension.We don't know whether combining orlistat and sibutramine treatment leads to greater weight loss than with either treatment alone.We don't know whether diethylpropion and mazindol are effective at promoting weight loss in people with obesity.Orlistat has been associated with GI adverse effects.Phentermine has been associated with heart and lung problems.Sibutramine has been associated with cardiac arrhythmias and cardiac arrest. In January 2010, the European Medicines Agency suspended marketing authorisation of sibutramine in the European Union because of the increased risk of non-fatal myocardial infarctions and strokes.In October 2010, the FDA requested the withdrawal of sibutramine from the US market because of the increased risk of adverse cardiovascular events.Rimonabant has been associated with an increased risk of psychiatric disorders.
Bariatric surgery (gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding) may increase weight loss compared with no surgery in people with morbid obesity.
Compared with each other, we don't know whether gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding is the most effective surgery or the least harmful. We don't know whether sleeve gastrectomy is effective. Bariatric surgery may result in loss of >20% of body weight, which may be largely maintained for 10 years.Operative and postoperative complications are common, and on average 0.28% of people die within 30 days of surgery. Mortality may be as high as 2% in some high-risk populations. However, surgery may reduce long-term mortality compared with no surgery.
PMCID: PMC3217730  PMID: 21411021
7.  Bariatric Surgery for Severe Obesity in Two Adolescents With Type 1 Diabetes 
Pediatrics  2013;132(4):e1031-e1034.
Bariatric surgery has been effective in treating type 2 diabetes mellitus (T2DM); it has not been used frequently in obese patients with type 1 diabetes mellitus (T1DM). This is the first case series reporting on the effect of bariatric surgery on diabetes control in adolescents with T1DM. Patient A is a 19-year-old obese man with T1DM who underwent vertical sleeve gastrectomy. At 12 months after surgery he demonstrated 28% reduction in BMI. His daily total insulin requirement had decreased; however, hemoglobin A1c remained primarily unchanged at 8.8%. Patient B is a 13-year-old obese girl with an initial clinical diagnosis of T2DM controlled on only metformin. She underwent Roux-en-Y gastric bypass; at 1 month after surgery she presented in diabetic ketoacidosis and was found to have positive islet cell antibodies, which were also present before surgery. Her diagnosis was revised to T1DM, and she was started on insulin. By 28 months after surgery her BMI had decreased by 42%. Since initiation of insulin, her daily total insulin requirement had decreased, but hemoglobin A1c had significantly worsened from 6.3% to 10%. We found that despite significant weight loss, improvements in cardiovascular risk factors (dyslipidemia and obstructive sleep apnea), and quality of life in our patients, bariatric surgery does not necessarily lead to improved glycemic control of T1DM. Patients with T1DM have ongoing dependency on exogenous insulin, and optimal glycemic control still depends on patient compliance with diabetes care.
doi:10.1542/peds.2012-3640
PMCID: PMC3784289  PMID: 24062368
bariatric surgery; diabetes mellitus; type 1; adolescents
8.  Enhanced Recovery After Bariatric Surgery (ERABS): Clinical Outcomes from a Tertiary Referral Bariatric Centre 
Obesity Surgery  2013;24(5):753-758.
There is paucity of data on Enhanced Recovery After Bariatric Surgery (ERABS) protocols. This feasibility study reports outcomes of this protocol utilized within a tertiary-referral bariatric centre. Data on consecutive primary procedures (laparoscopic gastric bypasses, sleeve gastrectomies and gastric bands) performed over 9 months within an ERABS protocol were prospectively recorded. Interventions utilized included shortened preoperative fasts, intra-operative humidification, early mobilization and feeding, avoidance of fluid overload, incentive spirometry, use of prokinetics and laxatives. Data collected included demographics, co-morbidities, morbidity, mortality, length of stay (LOS) and re-admissions. A total of 226 procedures (age [mean ± SD], 45 ± 11 years, median [interquartile range] BMI 44.9 [41.0–49.0] kg/m2) were undertaken: 150 (66 %) bypasses, 47 (21 %) sleeves and 29 (13 %) bands. Hypertension, diabetes mellitus, sleep apnea and limited mobility were present in 40 %, 34 %, 24 % and 9 % of patients, respectively. No anastomotic or staple line leaks/bleeds were encountered. Ten (4.4 %) patients developed postoperative morbidity (mainly respiratory complications). One death occurred from massive pulmonary embolus in a high-risk patient (despite insertion of preoperative-IVC filter). Respective mean ± SD LOS for bypasses, sleeves and bands were 1.88 ± 1.12, 2.30 ± 1.69 and 0.69 ± 0.81 days. Successful discharge on the first postoperative day was achieved in 37 % and 28 % of bypasses and sleeves, respectively. Day-case gastric bands were performed in 48 %. Thirty-day hospital re-admission occurred in six (2.7 %) patients. Applying an ERABS protocol was feasible, safe, associated with low morbidity, acceptable LOS and low 30-day re-admission rates. The presence of multiple medical co-morbidities should not preclude use of an ERABS protocol within bariatric patients.
doi:10.1007/s11695-013-1151-4
PMCID: PMC3972428  PMID: 24357126
Morbid obesity; Gastric bypass; Sleeve gastrectomy; Gastric band; Laparoscopic; Enhanced recovery; Fast track; Length of stay; Complications; Bariatric surgery; Co-morbidities
9.  Bariatric Surgery in Moderately Obese Patients: A Prospective Study 
Introduction. Moderate obesity (BMI 30–35 kg/m2) affects 25% of the western population. The role of bariatric surgery in this context is currently debated, reserved for patients with comorbidity, as an alternative to conservative medical treatment. We describe our experience in moderately obese patients treated with bariatric surgery. Materials and Methods. Between September 2011 and September 2012, 25 patients with grade I obesity and comorbidities underwent bariatric surgery: preoperative mean BMI 33.2 kg/m2, 10 males, mean age 42 years. In presence of type 2 diabetes mellitus (T2DM) (56%), gastric bypass was performed; in cases with hypertension (64%) and obstructive sleep apnea (OSA) (12%), sleeve gastrectomy was performed. All operations were performed laparoscopically. Results. Mean follow-up was 12.4 months. A postoperative complication occurred: bleeding from the trocar site was resolved with surgery in local anesthesia. Reduction in average BMI was 6 points, with a value of 27.2 kg/m2. Of the 14 patients with T2DM, 12 (86%) discontinued medical therapy because of a normalization of glycemia. Of the 16 patients with arterial hypertension, 14 (87%) showed remission and 2 (13%) improvement. Complete remission was observed in patients with OSAS. Conclusions. The results of our study support the validity of bariatric surgery in patients with BMI 30–35 kg/m2. Our opinion is that, in the future, bariatric surgery could be successful in selected cases of moderately obese patients.
doi:10.1155/2013/276183
PMCID: PMC3884634  PMID: 24454338
10.  Robot-Assisted Sleeve Gastrectomy in Morbidly Obese Versus Super Obese Patients 
Background and Objectives:
This study evaluates our technique for robot-assisted sleeve gastrectomy for morbidly obese and super obese patients and our outcomes.
Methods:
A retrospective analysis of patients who underwent robot-assisted sleeve gastrectomy at a single center was performed. The procedure was performed with the da Vinci Si HD Surgical System (Intuitive Surgical, Sunnyvale, California). The staple line was imbricated with No. 2-0 polydioxanone in all cases. The super obese (body mass index ≥50 kg/m2) subset of patients was compared with the morbidly obese group in terms of demographic characteristics, comorbidities, operative times, perioperative complications, and excess body weight loss.
Results:
A total of 35 patients (15 female and 20 male patients) with a mean body mass index of 48.17 ± 11.7 kg/m2 underwent robot-assisted sleeve gastrectomy. Of these patients, 11 were super obese and 24 were morbidly obese. The mean operative time was 116.3 ± 24.7 minutes, and the mean docking time was 8.9 ± 5.4 minutes. Mean blood loss was 19.36 ± 4.62 mL, and there were no complications, conversions, or perioperative deaths. When compared with the morbidly obese patients, the super obese patients showed no significant difference in operative time, blood loss, and length of hospital stay. There was a steep decline in operating room times after 10 cases of robot-assisted sleeve gastrectomy.
Conclusion:
This study shows the feasibility and safety of robot-assisted sleeve gastrectomy. Robotic assistance might help overcome the operative difficulties encountered in super obese patients. It shows a rapid reduction in operative times with the growing experience of the entire operative team. Robot-assisted sleeve gastrectomy can be a good procedure by which to introduce robotics in a bariatric surgery center before going on to perform Roux-en-Y gastric bypass and revision procedures.
doi:10.4293/JSLS.2014.00099
PMCID: PMC4208899  PMID: 25392663
Sleeve gastrectomy; Robot-assisted bariatric surgery; Super obese; Robotic surgery; Laparoscopic bariatric; Robotic sleeve
11.  Metabolic Effects of Sleeve Gastrectomy in a Female Rat Model of Diet-Induced Obesity 
Background
While females disproportionately undergo bariatric surgery, rodent models investigating mechanisms of bariatric surgery have been limited to males. Female rodent models can also potentially allow us to understand the effects of surgical intervention on future generations of offspring. Sleeve gastrectomy is an attractive weight loss procedure for reproductive-age female patients as it avoids the malabsorption associated with intestinal bypass.
Objectives
We sought to evaluate the impact of sleeve gastrectomy on young female rats with diet-induced obesity.
Settings
David Geffen School of Medicine at UCLA
Methods
Sprague Dawley female rats were fed a 60% high-fat diet. At 12 weeks of age, animals underwent either sleeve gastrectomy or sham surgery. Animals were sacrificed four weeks after surgery. A chemistry panel was performed, and serum adipokines and gut hormones were assayed. Homeostasis model assessment score (HOMA) was calculated. Liver histology was graded for steatosis. Two-sample t-test was used to compare groups.
Results
Sleeve gastrectomy was associated with significant weight loss (5±6% vs. −4±6%; p<0.001), lower leptin levels (1.3±1.2 vs. 3.5±2.3 ng/ml; p<0.01), and higher adiponectin levels (0.43 ± 0.19 vs. 0.17 ± 0.14 ng/ml; p<0.004) when compared to sham animals. There were no significant differences in fasting ghrelin. Furthermore, we did not observe evidence of insulin resistance or steatohepatitis after 11 weeks of high-fat diet. Despite these limitations, further gender-specific studies are warranted given that the majority of bariatric surgeries are performed in females.
Conclusion
Sleeve gastrectomy appears to result in weight loss and improvements in adiponectin and leptin via mechanisms independent of ghrelin in a female model of diet-induced obesity.
doi:10.1016/j.soard.2011.09.025
PMCID: PMC3288965  PMID: 22093377
12.  Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus☆ 
INTRODUCTION
We report the first case of laparoscopic sleeve gastrectomy with loop bipartition (a modified form of Santoro's operation) in the treatment of type II diabetes mellitus associated with obesity.
PRESENTATION OF CASE
A 46-year-old gentleman (baseline BMI 32.9; BW 98.5 kg) with 7-year history of type II diabetes mellitus (DM) underwent the procedure in Hong Kong. The control of DM was poor even with intensive medical therapy before the operation. Standard laparoscopic sleeve gastrectomy (SG) was performed and a loop gastroileostomy was fashioned at the antrum 250 cm from the ilececal valve without division of the 1st part of duodenum after SG. The resultant gastric tube has two outlets, one to the first part of duodenum and the other to the ileum with preferential passage of food through the gastroileostomy as shown on subsequent contrast study. The patient's recovery was uneventful. The excess BMI loss was 97% with complete normalization of all metabolic parameters at 1-year follow-up.
DISCUSSION
This new surgical procedure (sleeve gastrectomy with loop bipartition: SG+LB) was evolved and derived from the combined concepts of sleeve gastrectomy with transit bipartition (SG+TB), single anastomosis duodenal-ileostomy (SADI), mini-gastric bypass (MGB) and duodenal-jejunal bypass (DJB) with less nutritional and surgical complications.
CONCLUSION
Sleeve gastrectomy with loop bipartition may be a very effective and simple operation to treat uncontrolled DM associated with obesity with a lot of apparent advantages over most current metabolic procedures available at the moment.
doi:10.1016/j.ijscr.2013.12.002
PMCID: PMC3921657  PMID: 24441436
Laparoscopic sleeve gastrectomy; Bipartition; Diabetes mellitus
13.  Prospective randomized clinical trial of laparoscopic sleeve gastrectomy versus open Roux-en-Y gastric bypass for the management of patients with morbid obesity 
Introduction
Roux-en-Y gastric bypass (RYGB) is considered the gold standard bariatric procedure with documented safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure being done with increasing frequency. Randomized comparisons of LSG and other bariatric procedures are limited. We present the results of the first prospective randomized trial comparing LSG and RYGB in the Polish population.
Aim
To assess the efficacy and safety of LSG versus RYGB in the treatment of morbid obesity and obesity-related comorbidities.
Material and methods
Seventy-two morbidly obese patients were randomized to RYGB (36 patients) or LSG (36 patients). Both groups were comparable regarding age, gender, body mass index (BMI) and comorbidities. The follow-up period was at least 12 months. Baseline and 6 and 12 month outcomes were analyzed including assessment of percent excess weight lost (%EWL), reduction in BMI, morbidity (minor, major, early and late complications), mortality, reoperations, comorbidities and nutritional deficiencies.
Results
There was no 30-day mortality and no significant difference in major complication rate (0% after RYGB and 8.3% after LSG, p > 0.05) or minor complication rate (16.6% after RYGB and 10.1% after LSG, p > 0.05). There were no early reoperations after RYGB and 2 after LSG (5.5%) (p > 0.05). Weight loss was significant after RYGB and LSG but there was no difference between both groups at 6 and 12 months of follow-up. At 12 months %EWL in RYGB and LSG groups reached 64.2% and 67.6% respectively (p > 0.05). There was no significant difference in the overall prevalence of comorbidities and nutritional deficiencies.
Conclusions
Both LSG and RYGB produce significant weight loss at 6 and 12 months after surgery. The procedures are equally effective with regard to %EWL, reduction in BMI and amelioration of comorbidities at 6 and 12 months of follow-up. Laparoscopic sleeve gastrectomy and RYGB are comparably safe techniques with no significant differences in minor and major complication rates at 6 and 12 months.
doi:10.5114/wiitm.2012.32384
PMCID: PMC3557743  PMID: 23362420
bariatric surgery; morbid obesity; gastric bypass; sleeve gastrectomy; randomized trial
14.  Gastric Electrical Stimulation 
Executive Summary
Objective
The objective of this analysis was to assess the effectiveness, safety and cost-effectiveness of gastric electrical stimulation (GES) for the treatment of chronic, symptomatic refractory gastroparesis and morbid obesity.
Background
Gastroparesis - Epidemiology
Gastroparesis (GP) broadly refers to impaired gastric emptying in the absence of obstruction. Clinically, this can range from the incidental detection of delayed gastric emptying in an asymptomatic person to patients with severe nausea, vomiting and malnutrition. Symptoms of GP are nonspecific and may mimic structural disorders such as ulcer disease, partial gastric or small bowel obstruction, gastric cancer, and pancreaticobiliary disorders.
Gastroparesis may occur in association with diabetes, gastric surgery (consequence of peptic ulcer surgery and vagotomy) or for unknown reasons (idiopathic gastroparesis). Symptoms include early satiety, nausea, vomiting, abdominal pain and weight loss. The majority of patients with GP are women.
The relationship between upper gastrointestinal symptoms and the rate of gastric emptying is considered to be weak. Some patients with markedly delayed gastric emptying are asymptomatic and sometimes, severe symptoms may remit spontaneously.
Idiopathic GP may represent the most common form of GP. In one tertiary referral retrospective series, the etiologies in 146 GP patients were 36% idiopathic, 29% diabetic, 13% postgastric surgery, 7.5% Parkinson’s disease, 4.8% collagen vascular disorders, 4.1% intestinal pseudoobstruction and 6% miscellaneous causes.
The true prevalence of digestive symptoms in patients with diabetes and the relationship of these symptoms to delayed gastric emptying are unknown. Delayed gastric emptying is present in 27% to 58% of patients with type 1 diabetes and 30% with type 2 diabetes. However, highly variable rates of gastric emptying have been reported in type 1 and 2 diabetes, suggesting that development of GP in patients with diabetes is neither universal nor inevitable. In a review of studies examining gastric emptying in patients with diabetes compared to control patients, investigators noted that in many cases the magnitude of the delay in gastric emptying is modest.
GP may occur as a complication of a number of different surgical procedures. For example, vagal nerve injury may occur in 4% to 40% of patients who undergo laparoscopic fundoplication1 for gastroesophageal reflux disease.
The prevalence of severe, refractory GP is scantily reported in the literature. Using data from a past study, it has been estimated that the prevalence of severe, symptomatic and refractory GP in the United States population is 0.017%. Assuming an Ontario population of 13 million, this would correspond to approximately 2,000 people in Ontario having severe, symptomatic, refractory GP.
The incidence of severe refractory GP estimated by the United States Food and Drug Administration (FDA) is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year.
Treatment for Gastroparesis
To date, there have been no long-term studies confirming the beneficial effects of maintaining euglycemia on GP symptoms. However, it has been suggested that consistent findings of physiologic studies in healthy volunteers and diabetes patients provides an argument to strive for near-normal blood glucose levels in affected diabetes patients.
Dietary measures (e.g., low fibre, low fat food), prokinetic drugs (e.g., domperidone, metoclopramide and erythromycin) and antiemetic or antinausea drugs (e.g, phenothiazines, diphenhydramine) are generally effective for symptomatic relief in the majority of patients with GP.
For patients with chronic, symptomatic GP who are refractory to drug treatment, surgical options may include jejunostomy tube for feeding, gastrotomy tube for stomach decompression and pyloroplasty for gastric emptying.
Few small studies examined the use of botulinum toxin injections into the pyloric sphincter. However, the contribution of excessive pyloric contraction to GP has been insufficiently defined and there have been no controlled studies of this therapy.
Treatment with GES is reversible and may be a less invasive option compared to stomach surgery for the treatment of patients with chronic, drug-refractory nausea and vomiting secondary to GP. In theory, GES represents an intermediate step between treatment directed at the underlying pathophysiology, and the treatment of symptoms. It is based on studies of gastric electrical patterns in GP that have identified the presence of a variety of gastric arrhythmias. Similar to a cardiac pacemaker, it was hypothesized that GES could override the abnormal rhythms, stimulate gastric emptying and eliminate symptoms.
Morbid Obesity Epidemiology
Obesity is defined as a body mass index (BMI) of at last 30 kg/m2. Morbid obesity is defined as a BMI of at least 40 kg/m2 or at least 35 kg/m2 with comorbid conditions. Comorbid conditions associated with obesity include diabetes, hypertension, dyslipidemias, obstructive sleep apnea, weight-related arthropathies, and stress urinary incontinence.
In the United States, the age-adjusted prevalence of extreme obesity (BMI ≥ 40 kg/m2) for adults aged 20 years and older has increased significantly in the population, from 2.9% (1988–1994) to 4.7% (1999–2000). An expert estimated that about 160,000 to 180,000 people are morbidly obese in Ontario.
Treatment for Morbid Obesity
Diet, exercise, and behavioural therapy are used to help people lose weight.
Bariatric surgery for morbid obesity is considered an intervention of last resort for patients who have attempted first-line forms of medical management.
Gastric stimulation has been investigated for the treatment of morbid obesity; the intention being to reduce appetite and induce early satiety possibly due to inhibitory effects on gastric motility and effects on the central nervous system (CNS) and hormones related to satiety and/or appetite.
Possible advantages to GES for the treatment of morbid obesity include reversibility of the procedure, less invasiveness than some bariatric procedures, e.g., gastric bypass, and less side effects (e.g., dumping syndrome).
The Device
Electrical stimulation is delivered via an implanted system that consists of a neurostimulator and 2 leads. The surgical procedure can be performed via either an open or laparoscopic approach. An external programmer used by the physician can deliver instructions to the GES, i.e., adjust the rate and amplitude of stimulation (Figure 1). GES may be turned off by the physician at any time or may be removed. The battery life is approximately 4-5 years
For treatment of GP, the GES leads are secured in the muscle of the lower stomach, 10 cm proximal to the pylorus (the opening from the stomach to the intestine), 1 cm apart and connected to an implantable battery-powered neurostimulator which is placed in a small pocket in the abdominal wall
For treatment of morbid obesity, GES leads are implanted along the lesser curvature of the stomach where the vagal nerve branches spread, approximately 8 cm proximal to the pylorus. However, the implant positioning of the leads has been variably reported in the literature.
Regulatory Status
The Enterra Therapy System and the Transcend II Implantable Gastric Stimulation System (Medtronic Inc.) are both licensed as class 3 devices by Health Canada (license numbers 60264 and 66948 respectively). The Health Canada indications for use are:
Enterra Therapy System
“For use in the treatment of chronic intractable (drug-refractory) nausea and vomiting.”
Transcend II Implantable Gastric Stimulation System
“For use in weight reduction for obese adults with a body mass index greater than 35.”
The GES device that is licensed by Health Canada for treatment of GP, produces high-frequency GES. Most clinical studies examining GES for GP have used high-frequency (4 times the intrinsic slow wave frequency, i.e., 12 cycles per minute), low energy, short duration pulses. This type of stimulation does not alter gastric muscular contraction and has no effect on slow wave dysrhythmias. The mechanism of action is unclear but it is hypothesized that high-frequency GES may act on sensory fibers directed to the CNS.
The GES device licensed by Health Canada for treatment of morbid obesity produces low-frequency GES, which is close to or just above the normal/native gastric slow wave cycle (approximately 3 cycles/min.). This pacing uses low-frequency, high-energy, long-duration pulses to induce propagated slow waves that replace the spontaneous ones. Low-frequency pacing does not invoke muscular contractions.
Most studies examining the use of GES for the treatment of morbid obesity use low-frequency GES. Under normal circumstances, the gastric slow wave propagates distally and determines the frequency and propagation direction of gastric peristalsis. Low-frequency GES aims to produce abnormal gastric slow waves that can induce gastric dysrhythmia, disrupt regular propagation of slow waves, cause hypomotility of the stomach, delay gastric emptying, reduce food intake, prolong satiety, and produce weight loss.
In the United States, the Enterra Therapy System is a Humanitarian Use Device (HUD), meaning it is a medical device designated by the FDA for use in the treatment of medical conditions that affect fewer than 4,000 individuals per year.2 The Enterra Therapy System is indicated for “the treatment of chronic, drug- refractory nausea and vomiting secondary to GP of diabetes or idiopathic etiology” (not postsurgical etiologies).
GES for morbid obesity has not been approved by the FDA and is for investigational use only in the United States.
Review Strategy
The Medical Advisory Secretariat systematically reviewed the literature to assess the effectiveness, safety, and cost-effectiveness of GES to treat patients who have: a) chronic refractory symptomatic GP; or b) morbid obesity.
The Medical Advisory Secretariat used its standard search strategy to retrieve international health technology assessments and English-language journal articles from selected databases.
The GRADE approach was used to systematically and explicitly make judgments about the quality of evidence and strength of recommendations.
Findings
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence in Tables 1 and 2.
GRADE Quality of Studies – Gastroparesis
Confounders related to diabetes.
Possible Type 2 error for subgroup analyses.
Subjective self-reported end point.
Posthoc change in primary end point analysis.
No sample size justification.
Concomitant prokinetic/antiemetic therapy.
Only 1 RCT (with different results for FDA and publication).
GES originally hypothesized to correct gastric rhythms, stimulate gastric emptying and therefore eliminate symptoms.
Now hypothesized to directly act on neurons to the CNS to control symptoms.
Weak correlation between symptoms and gastric emptying.
Unclear whether gastric emptying is still considered an end point to investigate.
GRADE Quality of Studies – Morbid Obesity
No sample size calculation.
Small sample size.
No ITT analysis.
Lack of detail regarding dropouts.
Possible Type 2 error.
Sparse details about randomization/blinding.
Full, final results not published.
Only 1 RCT (technically grey literature).
Economic Analysis
No formal economic analysis was identified in the literature search.
The Alberta Heritage Foundation for Medical Research reported that the cost of implanting a GES in the United States for the treatment of GP is estimated to be $30,000 US. In Canada, the device costs approximately $10,700 Cdn; this does not include costs associated with the physician’s training, the implantation procedure, or device programming and maintenance.
Ontario Context
There is no Schedule of Benefits code for GES.
There is no Canadian Classification of Health Interventions Index (CCI) procedure code for GES.
Since the ICD-10 diagnosis code for gastroparesis falls under K31.8 “Other specified diseases of the stomach and duodenum”, it is impossible to determine how many patients in Ontario had discharge abstracts because of gastroparesis.
In 2005, there were less than 5 out-of-country requests for GES (for either consultation only or for surgery).
Gastroparesis
The prevalence of severe, refractory GP is variably reported in the literature.
The Alberta Heritage Foundation for Medical Research estimated that the prevalence of severe, symptomatic and medically refractory GP in the United States population was 0.017%. Assuming a total Ontario population of 13 million, this would correspond to a budget impact of approximately $23.6 M
Cdn ($10,700 Cdn x 2,210 patients) for the device cost alone.
The incidence of severe refractory GP estimated by the FDA is approximately 4,000 per year in the United States. This corresponds to about 150 patients in Ontario. Using expert opinion and FDA data, the incidence of severe refractory GP in Ontario is estimated to be about 20 to 150 per year. This corresponds to a budget impact of approximately $107,000 Cdn to $1.6M Cdn per year for the device cost alone.
Morbid Obesity
An expert in the field estimated that there are 160,000 to 180,000 people in Ontario who are morbidly obese. This would correspond to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake). However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Conclusion
As per the GRADE Working Group, overall recommendations consider 4 main factors.
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 shows the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For GP, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality, consistency and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $107,000 Cdn to $1.6M Cdn for the device cost alone, while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high-quality studies of effectiveness. Further evidence of effectiveness should be available in the future since there is a RCT underway that is examining the use of GES in patients with severe refractory GP associated with diabetes and idiopathic etiologies (ClinicalTrials.gov identifier NCT00157755).
For morbid obesity, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and consistency), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $1.7B Cdn to $1.9B Cdn for the device cost alone (assuming 100% uptake) while the cost-effectiveness of GES is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. However, the true uptake of GES for morbid obesity is unknown in relation to other types of bariatric surgery (which are more effective).
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3413096  PMID: 23074486
15.  Sleeve Gastrectomy as a Stand-alone Bariatric Operation for Severe, Morbid, and Super Obesity 
Laparoscopic sleeve gastrectomy was found to be a safe and effective stand-alone procedure for severe, morbid, and super obese patients in a high-risk veteran population.
Background:
The laparoscopic sleeve gastrectomy (LSG) is emerging as an effective bariatric operation and is especially attractive in high-risk populations. In this study we examine the efficacy of LSG as a stand-alone operation in the veteran population.
Methods:
This is a retrospective review of consecutive patients who underwent LSG as a stand-alone procedure at the Palo Alto Veterans Affairs medical center with a minimum 12-month follow-up.
Results:
Of 205 patients undergoing bariatric surgery, 71 patients had a sleeve gastrectomy, 40 of whom had the operation performed at least 12 months previously. Thirty-six (90%) were available for 1-year follow-up, with a mean follow-up duration of 22 months (range: 12–42), a mean body mass index of 48.3 kg/m2, and an 83% male population. Mean percent excess weight loss was 61% at an average of 22 months, with no significant difference between severely obese, morbidly obese, and super obese cohorts. Diabetes remission was seen in 56% of patients, hypertension remission in 51.6%, and obstructive sleep apnea remission in 46.4%, and gastroesophageal reflux disease improved or did not change in 83%. Medication use significantly decreased after surgery.
Conclusion:
LSG is safe and effective as a stand-alone bariatric operation in the high-risk veteran population. It is effective in severely obese, morbidly obese, and super obese patients. LSG induces remission or improvement in comorbidities of nearly all patients, translating to a decrease in medication use.
doi:10.4293/108680812X13517013317077
PMCID: PMC3662747  PMID: 23743373
Obesity; Sleeve gastrectomy; Bariatric surgery; Veterans; Diabetes; Hypertension; Obstructive sleep apnea; Gastroesphageal reflux
16.  Benign, Premalignant, and Malignant Lesions Encountered in Bariatric Surgery 
A bariatric surgeon needs to be aware of the possibility of benign tumors and cancer in obese patients as well as the optimal management of these conditions that may be present at the time of evaluation for bariatric surgery.
Background:
Obesity is associated with several comorbidities like diabetes, hypertension, hyperlipidemia, and obstructive sleep apnea. It is also well established that obese patients have an increased risk of several types of cancer like kidney, pancreas, endometrial, breast, and others. The bariatric surgeon needs to be aware of the problem of benign tumors and cancer in obese patients as well as the optimal management of these conditions that may be present at the time of evaluation for bariatric surgery, during the surgical procedure, and in the postoperative period.
Database:
A PubMed search for the words “cancer” and “bariatric surgery” and subsequent review of the abstracts identified 40 articles concerning cancerous, benign, and premalignant conditions in bariatric surgery patients. Data were then extracted from full-text articles.
Conclusion:
Bariatric surgery decreases cancer risk especially in women. RYGB can be an effective treatment for Barrett's esophagus. Patients having esophageal cancer should not undergo bariatric surgery, while those who develop the same postoperatively are usually managed by a combined abdominal and thoracic approach (Ivor Lewis technique). Gastric cancer of the remnant stomach is usually managed by a remnant gastrectomy. A remnant gastrectomy during RYGB would be necessary in conditions that require endoscopic surveillance of the stomach like gastric polyps, intestinal metaplasia, and carcinoid tumors. Sleeve gastrectomy is an excellent option in a patient with GIST or a carcinoid who needs a bariatric operation. Preoperative endoscopy usually does not detect malignant conditions. Postoperative evaluation of the bypassed stomach is possible using various percutaneous and novel endoscopic techniques.
doi:10.4293/108680812X13462882736457
PMCID: PMC3535793  PMID: 23318060
Bariatric surgery; RYGB; GIST; Carcinoid; Gastric cancer; Esophageal cancer
17.  Restoration of Glycemic Control in Patients with Type 2 Diabetes Following Bariatric Surgery is Associated with Reduction in Microparticles 
Background
Microparticles bud from cellular elements during inflammation and are associated with vascular dysfunction related to type 2 diabetes. Although weight loss is known to reduce inflammation, the metabolic effects of bariatric surgery on microparticle concentration and composition are not known.
Objectives
To determine the effect of bariatric surgery on microparticle concentration and correlate these changes with clinical parameters.
Setting
Multispecialty group practice
Methods
We studied 14 obese subjects with type 2 diabetes two weeks before and at one and 12 months following bariatric surgery. Nine of the patients underwent Roux-en-Y gastric bypass and 5 received gastric restrictive surgery.
Results
One month following surgery, body mass index was reduced by ~10%, glycemic control improved dramatically (P < 0.01), and there was a >60% reduction in endothelial, platelet microparticles and CRP levels (P < 0.05). Tissue factor microparticles reduced by 40% ( p = 0.1). Twelve months following surgery, BMI was reduced by ~20%, glycemic control was maintained (P < 0.01), and there was a >50% reduction in monocyte microparticles compared to pre-surgery. The reduction in monocyte microparticles one month after surgery was strongly associated with the reduction in hemoglobin A1c (P < 0.05). The reduction in monocyte microparticles 12 months following surgery correlated strongly with the reduction in body mass index (P < 0.05).
Conclusion
The reduction in microparticles after bariatric surgery in patients with type 2 diabetes reflects an attenuation of inflammation and this mechanism may contribute to normalization of glycemic control.
doi:10.1016/j.soard.2011.09.026
PMCID: PMC3311701  PMID: 22093380
microparticles; tissue factor; inflammation; obesity; bariatric surgery; type 2 diabetes
18.  Clinical Experience of Weight Loss Surgery in Morbidly Obese Korean Adolescents 
Yonsei Medical Journal  2014;55(5):1366-1372.
Purpose
Comprehensive multidisciplinary weight management programs encompassing various conservative measures have shown only modest weight loss results in obese children and adolescents; therefore, bariatric surgery for this population has become a matter of discussion. This study aimed to present our experience with and outcomes for laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in morbidly obese Korean adolescents.
Materials and Methods
The prospectively established database of all patients undergoing bariatric surgery at Soonchunhyang University Seoul Hospital, Korea between January 2011 and January 2013 was retrospectively reviewed. Adolescents aged 14 to 20 years were included in the present analyses.
Results
Twenty-two adolescents underwent bariatric surgery during the study period; 14 underwent LSG and 8, LRYGB. Of these, 17 were female and 5 were male. The mean age was 19 years. Their mean body weight and body mass index (BMI) before surgery were 115 kg and 40.1 kg/m2. The only postoperative complication was intraluminal bleeding in 1 patient, which was managed conservatively. The mean BMI decreased to 29.1 kg/m2 after a mean follow-up of 10 months. The percent excess weight loss (%EWL) at 1, 3, 6, and 12 months postoperatively were 19.6, 39.9, 52.6, and 74.2%, respectively. Only 1 patient showed %EWL less than 30% at 12 months after surgery. All patients with diabetes and sleep apnea were cured of their disease, and other comorbidities also improved or resolved after surgery.
Conclusion
Bariatric surgery leads to significant short-term weight loss along with resolution of obesity-related comorbidities in obese children and adolescents.
doi:10.3349/ymj.2014.55.5.1366
PMCID: PMC4108825  PMID: 25048498
Morbid obesity; adolescent obesity; bariatric surgery; gastric bypass
19.  Effects of glucagon like peptide-1 to mediate glycemic effects of weight loss surgery 
To date, weight loss surgeries are the most effective treatment for obesity and glycemic control in patients with type 2 diabetes. Roux-en-Y gastric bypass surgery (RYGB) and sleeve gastrectomy (SG), two widely used bariatric procedures for the treatment of obesity, induce diabetes remission independent of weight loss while glucose improvement after adjustable gastric banding (AGB) is proportional to the amount of weight loss. The immediate, weight-loss independent glycemic effect of gastric bypass has been attributed to postprandial hyperinsulinemia and an enhanced incretin effect. The rapid passage of nutrients into the intestine likely accounts for significantly enhanced glucagon like-peptide 1 (GLP-1) secretion, and postprandial hyperinsulinemia after GB is typically attributed to the combined effects of elevated glucose and GLP-1. For this review we focus on the beneficial effects of the three most commonly performed bariatric procedures, RYGB, SG, and AGB, on glucose metabolism and diabetes remission. Central to this discussion will be the extent to which the effects of surgery are mediated by GLP-1. Better understanding of these mechanisms could provide insight to development of novel therapeutic strategies for treatment of diabetes as well as refinement of surgical techniques.
doi:10.1007/s11154-014-9291-y
PMCID: PMC4119589  PMID: 24951252
Gastric bypass surgery; Sleeve gastrectomy; GLP-1; Hyperinsulinemia; Diabetes; Hypoglycemia
20.  STOP-Bang and the effect on patient outcome and length of hospital stay when patients are not using continuous positive airway pressure 
Journal of Anesthesia  2014;28:891-897.
Background
In patients undergoing surgical interventions under general anesthesia, obstructive sleep apnea syndrome (OSA) can cause serious perioperative cardiovascular or respiratory complications leading to fatal consequences, even sudden death. In this study we test the hypothesis that morbidly obese patients diagnosed by a polysomnography test and using continuous positive airway pressure (CPAP) therapy have fewer and less severe perioperative complications and a shorter hospital stay than patients who have a medical history that meets at least three STOP-Bang criteria and are not using CPAP therapy.
Methods
Postoperative hospital stay and pulmonary complications were analyzed in three groups of morbidly obese patients undergoing bariatric surgery (Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy) between January 2009 and November 2013 (n = 693). Group A comprised 99 patients who were preoperatively diagnosed with OSA based on polysomnography results. These patients used CPAP therapy before and after surgery. Group B consisted of 182 patients who met at least three STOP-Bang criteria but who were not diagnosed with OSA based on polysomnography results. These patients did not use CPAP. Group C, the reference group, comprised 412 patients who scored one to two items on the STOP-Bang.
Results
During the perioperative period, Group B patients had a significantly (p < 0.001) higher cumulative rate of pulmonary complications, worse oxygen saturation, respiratory rates, and increased length of stay in hospital. There was also two cases of sudden death in this group.
Conclusion
Based on these results, we conclude that patients meeting at least three STOP-BANG criteria have higher postoperative complications and an increased length of hospital stay than patients using CPAP.
doi:10.1007/s00540-014-1848-0
PMCID: PMC4263911  PMID: 24871541
Obstructive sleep apnea syndrome; Morbid obesity; Postoperative complications; Sudden death
21.  Early Postoperative Outcomes and Medication Cost Savings after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients with Type 2 Diabetes 
Journal of Obesity  2011;2011:350523.
Background. We investigated the effect of laparoscopic sleeve gastrectomy (LSG) on morbidly obese diabetics and examined the short-term impact of LSG on diabetic medication cost. Methods. A prospective database of consecutive bariatric patients was reviewed. Morbidly obese patients with type 2 diabetes who underwent LSG were included in the study. Age, gender, body mass index (BMI), diabetic medication use, glucose, insulin, and HbA1c levels were documented preoperatively, and at 2 weeks, 2 months, 6 months, and 12 months postoperatively. Insulin resistance was estimated using the homeostatic model assessment (HOMA). Use and cost of diabetic medications were followed. Results. Of 178 patients, 22 were diabetics who underwent LSG. Diabetes remission was observed in 62% of patients within 2 months and in 75% of patients within 12 months. HOMA-IR improved after only two weeks following surgery (16.5 versus 6.6, P < 0.001). Average number of diabetic medications decreased from 2.2 to <1, within 2 weeks after surgery; corresponding to a diabetes medication cost savings of 80%, 91%, 99%, and 99.7% after 2 weeks, 2 months, 6 months, and 12 months, respectively. Conclusion. Morbidly obese patients with diabetes who undergo LSG have high rates of diabetes remission early after surgery. This translates to a significant medication cost savings.
doi:10.1155/2011/350523
PMCID: PMC3236514  PMID: 22187636
22.  Bariatric Surgery for People with Diabetes and Morbid Obesity 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/masabout.html,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
Objective
The purpose of this evidence-based analysis was to examine the effectiveness and cost-effectiveness of bariatric surgery for the management of diabetes in morbidly obese people.
This report summarized evidence specific to bariatric surgery and the improvement of diabetes from the full evidence-based analysis of bariatric surgery for the treatment of morbid obesity completed by the Medical Advisory Secretariat (MAS) in January 2005. To view the full report, please visit the MAS website at: http://www.health.gov.on.ca/english/providers/program/mas/tech/techmn.html.
Clinical Need: Condition and Target Population
Obesity is defined as an excessive accumulation of body fat as measured by the body mass index (BMI) and calculated as body weight in kilograms (kg) divided by height in metres squared (m2). People with a BMI over 30 kg/m2 are considered obese in most countries. The condition is associated with the development of several diseases, including hypertension, diabetes mellitus (type 2 diabetes), hyperlipidemia, coronary artery disease, obstructive sleep apnea, depression, and cancers of the breast, uterus, prostate, and colon. Clinically severe, or morbid obesity, is commonly defined by a BMI of at least 40 kg/m2, or a BMI of at least 35 kg/m2 if there are comorbid conditions such as diabetes, cardiovascular disease, or arthritis.
The prevalence of morbid obesity among people with type 2 diabetes has been examined and of 2,460 patients with type 2 diabetes, 52% (n = 1,279) were obese (BMI ≥ 30 kg/m2) and 23% (n = 561) had a BMI ≥ 35 kg/m2.
Bariatric Surgery
Men and women with morbid obesity may be eligible for surgical intervention. There are numerous surgical options available, all of which can be divided into two general types, both of which can be performed either as open surgery or laparoscopically:
malabsorptive - bypassing parts of the gastrointestinal tract to limit the absorption of food, and
restrictive - decreasing the size of the stomach in order for the patient to feel satiated with a smaller amount food
Surgery for morbid obesity is usually considered a last resort for people who have attempted first-line medical management (e.g. diet, behaviour modification, increased physical activity, and drugs) but who have not lost weight permanently. Surgery is restricted to people with morbid obesity (BMI ≥ 40 kg/m2) or those with a BMI of at least 35 kg/m2 and serious comorbid conditions.
Evidence-Based Analysis Methods
Details of the full literature search can be found in the 2005 evidence-based analysis of bariatric surgery (http://www.health.gov.on.ca/english/providers/program/mas/tech/techmn.html). Briefly, a literature search was conducted examining published works from January 1996 to December 2004, including OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), The Cochrane Library, and the International Agency for Health Technology Assessment/Centre for Review and Dissemination.
Inclusion Criteria
Data on the effectiveness or cost-effectiveness of bariatric surgery for the improvement of diabetes
Systematic reviews, randomized controlled trials (RCTs), and observational controlled prospective studies that had >100 patients
Randomized controlled trials (RCTs), systematic reviews and meta-analyses
Exclusion Criteria
Duplicate publications (superseded by another publication by the same investigator group, with the same objective and data)
Non-English-language articles
Non-systematic reviews, letters, and editorials
Animal and in-vitro studies
Case reports, case series
Studies that did not examine the outcomes of interest
Outcomes of Interest
Improvement or resolution of diabetes
The quality of the studies was examined according to the GRADE Working Group criteria for grading quality of evidence.
Summary of Findings
There is evidence that bariatric surgery is effective for improvement and resolution of diabetes in patients who are morbidly obese (BMI≥35 kg/m2). The quality of evidence for the use of bariatric surgery for the resolution or improvement of diabetes in morbidly obese people, according to the GRADE quality-of-evidence criteria, was found to be moderate (see ES Table 1).
Comparison of various bariatric techniques:
No prospective, long-term direct comparison is available between malabsorptive and restrictive techniques.
Retrospective subgroup analyses from a large observational study showed greater improvement and resolution of diabetes using malabsorptive techniques rather than purely restrictive methods.
There is evidence from a meta-analysis that malabsorptive techniques are better than other banding techniques in terms of improvement and resolution of diabetes.
Keywords
Bariatric surgery, morbid obesity, comorbidity, diabetes
GRADE Quality of Evidence for Bariatric Surgery for the Resolution or Improvement of Diabetes
Downgraded due to study design (not randomized controlled trial)
Unlikely to be an important uncertainty. Inclusion criteria for the SOS study not specific to conventional definition of “morbidly obese” patients (BMI ≥ 40 or ≥ 35 kg/m2 with comorbid conditions)
Unlikely to be an important uncertainty. Control group not standardized, however, this lends to the pragmatic nature of the study.
PMCID: PMC3377514  PMID: 23074527
23.  Bariatric Surgery: A Systematic Review of the Clinical and Economic Evidence 
Journal of General Internal Medicine  2011;26(10):1183-1194.
CONTEXT
Use of bariatric surgery for severe obesity has increased dramatically.
OBJECTIVE
To systematically review 1. the clinical efficacy and safety, 2. cost-effectiveness of bariatric surgery, and 3. the association between number of surgeries performed (surgical volume) and outcomes.
DATA SOURCES
MEDLINE (from 1950), EMBASE (from 1980), CENTRAL, EconLit, EURON EED, Harvard Center for Risk Analysis, trial registries and HTA websites were searched to January 2011.
STUDY SELECTION
1. Randomized controlled trials (RCTs) and 2. cost-utility and cost-minimisation studies comparing a contemporary bariatric surgery (i.e., adjustable gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy) to another contemporary surgical comparator or a non-surgical treatment or 3. Any study reporting the association between surgical volume and outcome.
DATA EXTRACTION
Outcomes included changes in weight and obesity-related comorbidity, quality of life and mortality, surgical complications, resource utilization, and incremental cost-utility.
RESULTS
RCT data evaluating mortality and obesity-related comorbidity endpoints were lacking. A small RCT of 16 patients reported that adjustable gastric banding reduced weight by 27% (p < 0.01) compared to diet-treated controls over 40 weeks. Six small RCTs reported comparisons of commonly used, contemporary procedures. Gastric banding reduced weight to a lower extent than gastric bypass and sleeve gastrectomy and resulted in shorter operating times, fewer serious complications, lower weight loss efficacy, and more frequent reoperations compared to gastric bypass. Sleeve gastrectomy and gastric bypass reduced weight to a similar extent. A 2-year RCT in 50 adolescents reported that gastric banding substantially reduced weight compared to lifestyle modification (35 kg vs. 3 kg; p <0.001). Based on findings of 14 observational studies, higher volume centers and surgeons had lower mortality and complication rates. Surgery resulted in long-term incremental cost–utility ratios of $ <1.000–$40,000 (2009 USD) per quality-adjusted-life-year compared with non-surgical treatment.
CONCLUSIONS
Contemporary bariatric surgery appears to result in sustained weight reduction with acceptable costs but rigorous, longer-term (≥5 year) data are needed and a paucity of RCT data on mortality and obesity related comorbidity is evident. Procedure-specific variations in efficacy and risks exist and require further study to clarify the specific indications for and advantages of different procedures.
doi:10.1007/s11606-011-1721-x
PMCID: PMC3181300  PMID: 21538168
randomized controlled trials; clincical evidence; economic evidence; systematic review
24.  A Gut Feeling to Cure Diabetes: Potential Mechanisms of Diabetes Remission after Bariatric Surgery 
Diabetes & Metabolism Journal  2014;38(6):406-415.
A cure for type 2 diabetes was once a mere dream but has now become a tangible and achievable goal with the unforeseen success of bariatric surgery in the treatment of both obesity and type 2 diabetes. Popular bariatric procedures such as Roux-en-Y gastric bypass and sleeve gastrectomy exhibit high rates of diabetes remission or marked improvement in glycemic control. However, the mechanism of diabetes remission following these procedures is still elusive and appears to be very complex and encompasses multiple anatomical and physiological changes. In this article, calorie restriction, improved β-cell function, improved insulin sensitivity, and alterations in gut physiology, bile acid metabolism, and gut microbiota are reviewed as potential mechanisms of diabetes remission after Roux-en-Y gastric bypass and sleeve gastrectomy.
doi:10.4093/dmj.2014.38.6.406
PMCID: PMC4273026  PMID: 25541603
Bariatric surgery; Diabetes mellitus, type 2; Obesity; Roux-en-Y gastric bypass; Sleeve gastrectomy
25.  Current status of bariatric surgery in Japan and effectiveness in obesity and diabetes 
Journal of Gastroenterology  2013;49(1):57-63.
The rate of obesity in Japan, defined as having a body mass index (BMI) of 25 kg/m2 or greater, is reportedly at 24 %, a lower level of severe obesity than in the EU and US. However, the incidence of obesity-related health problems is reportedly higher among Asians. Laparoscopic sleeve gastrectomy (LSG) is the most frequently performed bariatric surgery in Japan and accounted for 54 % of such surgeries in 2011; procedures such as laparoscopic adjustable gastric banding and laparoscopic Roux-en-Y gastric bypass (LRYGB), practiced frequently worldwide, were uncommon. Possible reasons include concern over delayed postoperative discovery of gastric cancer in LRYGB, and rapid adoption of the comparatively simple LSG procedure. In type 2 diabetes mellitus (T2DM) patients, where continued pursuit of medical treatment is difficult and a potential exists for future deterioration of diabetes-complicated diseases, the criterion for surgical indication in the EU and US is a BMI of 30–35 kg/m2, with priority given to BMI >35 kg/m2. For Asian patients, the recommendation is to lower this indication criterion by 2.5 kg/m2. Efficacy of metabolic surgery is anticipated particularly among T2DM patients with obesity complication, a short history of insulin treatment, and intact insulin secreting ability, and in these cases bariatric surgery should be contemplated.
doi:10.1007/s00535-013-0802-5
PMCID: PMC3895199  PMID: 23595611
Obesity; Diabetes mellitus; Bariatric surgery; Metabolic surgery; Sleeve gastrectomy; Gastric bypass

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