Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.
ABSTRACT: Importance:Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective:To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. Design, Setting, and Participants:The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Interventions:Laparoscopic sleeve gastrectomy (n?=?121) or laparoscopic Roux-en-Y gastric bypass (n?=?119). Main Outcomes and Measures:The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Results:Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n?=?15/41) after sleeve gastrectomy and in 45% (n?=?18/40) after gastric bypass (P?>?.99). Medication for dyslipidemia was discontinued in 47% (n?=?14/30) after sleeve gastrectomy and 60% (n?=?24/40) after gastric bypass (P?=?.15) and for hypertension in 29% (n?=?20/68) and 51% (n?=?37/73) (P?=?.02), respectively. There was no statistically significant difference in QOL between groups (P?=?.85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n?=?23) for sleeve gastrectomy and 26% (n?=?31) for gastric bypass (P?=?.19). Conclusions and Relevance:Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. Trial Registration:clinicaltrials.gov Identifier: NCT00793143.
Project description:Importance:Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown. Objective:To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events. Design, Setting, and Participants:The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period. Interventions:Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110). Main Outcomes and Measures:The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events. Results:Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P?=?.22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass. Conclusions and Relevance:Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery. Trial Registration:clinicaltrials.gov Identifier: NCT00356213.
Project description:BACKGROUND:Data from a US multicenter longitudinal study of bariatric surgery were used to compare weight change (primary outcome) and comorbidities (secondary outcome) in patients who underwent sleeve gastrectomy versus Roux-en-Y gastric bypass. METHODS:This study includes participants who underwent sleeve gastrectomy and matched participants who underwent Roux-en-Y gastric bypass from the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study. Adults undergoing initial bariatric surgical procedures between 2006 and 2009 were enrolled. Participants who underwent sleeve gastrectomy were high-risk or superobese and intended to have a second-stage procedure. Mixed models were used to evaluate percent weight change from baseline through 7 years, and diabetes, dyslipidemia, and hypertension prevalence through 5 years. RESULTS:Fifty-seven of 59 participants who underwent sleeve gastrectomy were matched one to one. Most were female (68%) and white (81%), and had a median age of 49 (37-56) years and median body mass index of 56.4 (35.5-76.8) kg/m2 presurgery. Weight loss was significantly less 1 to 7 years after sleeve gastrectomy versus matched Roux-en-Y gastric bypass (eg, year 7 mean weight loss was 23.6% vs 30.4%, respectively; P?=?.001). For both surgical groups, prevalence of diabetes, low high-density lipoprotein, and hypertension were significantly (P < .05) lower 5 years postsurgery versus baseline. CONCLUSION:Higher-risk or super-obese participants after sleeve gastrectomy lost less weight than did matched Roux-en-Y gastric bypass counterparts throughout 7 years. Both groups exhibited improvements in comorbidities from presurgery through 5 years.
Project description:BACKGROUND: Bariatric surgery is an effective treatment to obtain weight loss in severely obese patients. The feasibility and safety of bariatric robotic surgery is the topic of this review. METHODS: A search was performed on PubMed, Cochrane Central Register of Controlled Trials, BioMed Central, and Web of Science. RESULTS: Twenty-two studies were included. Anastomotic leak rate was 8.51% in biliopancreatic diversion. 30-day reoperation rate was 1.14% in Roux-en-Y gastric bypass and 1.16% in sleeve gastrectomy. Major complication rate in Roux-en-Y gastric bypass resulted higher than in sleeve gastrectomy ( 4,26% vs. 1,2%). The mean hospital stay was longer in Roux-en-Y gastric bypass (range 2.6-7.4 days). CONCLUSIONS: The major limitation of our analysis is due to the small number and the low quality of the studies, the small sample size, heterogeneity of the enrolled patients and the lack of data from metabolic and bariatric outcomes. Despite the use of the robot, the majority of these cases are completed with stapled anastomosis. The assumption that robotic surgery is superior in complex cases is not supported by the available present evidence. The major strength of the robotic surgery is strongly facilitating some of the surgical steps (gastro-jejunostomy and jejunojejunostomy anastomosis in the robotic Roux-en-Y gastric bypass or the vertical gastric resection in the robotic sleeve gastrectomy).
Project description:To evaluate the effects of two bariatric procedures versus intensive medical therapy (IMT) on ?-cell function and body composition.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/m(2)) randomized to IMT alone, IMT plus Roux-en-Y gastric bypass, or IMT plus sleeve gastrectomy. Assessment of ?-cell function (mixed-meal tolerance testing) and body composition was performed at baseline and 12 and 24 months.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. ?-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, ?-cell function inversely correlated with truncal fat and prandial free fatty acid levels.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 ?-cell function and reduces truncal fat, thus reversing the core defects in diabetes.
Project description:Bariatric surgery is an effective and safe approach for weight loss and short-term improvement in metabolic disorders such as diabetes. However, studies have been limited in most settings by lack of a nonsurgical group, losses to follow-up, missing data, and small sample sizes in clinical trials and observational studies.To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients.Retrospective cohort study in a large Israeli integrated health fund covering 54% of Israeli citizens with less than 1% turnover of members annually. Obese adult patients who underwent bariatric surgery between January 1, 2005, and December 31, 2014, were selected and compared with obese nonsurgical patients matched on age, sex, body mass index (BMI), and diabetes, with a final follow-up date of December 31, 2015. A total of 33?540 patients were included in this study.Bariatric surgery (laparoscopic banding, Roux-en-Y gastric bypass, or laparoscopic sleeve gastrectomy) or usual care obesity management only (provided by a primary care physician and which may include dietary counseling and behavior modification).The primary outcome, all-cause mortality, matched and adjusted for BMI prior to surgery, age, sex, socioeconomic status, diabetes, hyperlipidemia, hypertension, cardiovascular disease, and smoking.The study population included 8385 patients who underwent bariatric surgery (median age, 46 [IQR, 37-54] years; 5490 [65.5%] women; baseline median BMI, 40.6 [IQR, 38.5-43.7]; laparoscopic banding [n?=?3635], gastric bypass [n?=?1388], laparoscopic sleeve gastrectomy [n?=?3362], and 25?155 nonsurgical matched patients (median age, 46 [IQR, 37-54] years; 16?470 [65.5%] women; baseline median BMI, 40.5 [IQR, 37.0-43.5]). The availability of follow-up data was 100% for all-cause mortality. There were 105 deaths (1.3%) among surgical patients during a median follow-up of 4.3 (IQR, 2.8-6.6) years (including 61 [1.7%] who underwent laparoscopic banding, 18 [1.3%] gastric bypass, and 26 [0.8%] sleeve gastrectomy), and 583 deaths (2.3%) among nonsurgical patients during a median follow-up of 4.0 (IQR, 2.6-6.2) years. The absolute difference was 2.51 (95% CI, 1.86-3.15) fewer deaths/1000 person-years in the surgical vs nonsurgical group. Adjusted hazard ratios (HRs) for mortality among nonsurgical vs surgical patients were 2.02 (95% CI, 1.63-2.52) for the entire study population; by surgical type, HRs were 2.01 (95% CI, 1.50-2.69) for laparoscopic banding, 2.65 (95% CI, 1.55-4.52) for gastric bypass, and 1.60 (95% CI, 1.02-2.51) for laparoscopic sleeve gastrectomy.Among obese patients in a large integrated health fund in Israel, bariatric surgery using laparoscopic banding, gastric bypass, or laparoscopic sleeve gastrectomy, compared with usual care nonsurgical obesity management, was associated with lower all-cause mortality over a median follow-up of approximately 4.5 years. The evidence of this association adds to the limited literature describing beneficial outcomes of these 3 types of bariatric surgery compared with usual care obesity management alone.
Project description:<h4>Background</h4>Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are two representative bariatric surgeries. This study aimed to compare the effects of the LSG and LRYGB based on high-quality analysis and massive amount of data.<h4>Methods</h4>For this study databases of PubMed, Web of Science, EBSCO, Medline, and Cochrane Library were searched for articles published until January 2019 comparing the outcomes of LSG and LRYGB.<h4>Results</h4>This study included 28 articles. Overall, 9038 patients (4597, LSG group; 4441, LRYGB group) were included. The remission rate of type 2 diabetes mellitus (T2DM) in the LRYGB group was superior to that in the LSG group at the 3-years follow-up. Five-year follow-up results showed that LRYGB had an advantage over LSG for the percentage of excess weight loss and remission of T2DM, hypertension, dyslipidemia, and abnormally low-density lipoprotein.<h4>Conclusions</h4>In terms of the long-term effects of bariatric surgery, the effect of LRYGB was better than of LSG.
Project description:Bariatric surgery is an accepted treatment for obesity. Despite extensive literature, few studies report long-term follow-up in cohorts with adequate retention rates.To assess the quality of evidence and treatment effectiveness 2 years after bariatric procedures for weight loss, type 2 diabetes, hypertension, and hyperlipidemia in severely obese adults.MEDLINE and Cochrane databases were searched from 1946 through May 15, 2014. Search terms included bariatric surgery, individual bariatric procedures, and obesity. Studies were included if they described outcomes for gastric bypass, gastric band, or sleeve gastrectomy performed on patients with a body mass index of 35 or greater, had more than 2 years of outcome information, and had follow-up measures for at least 80% of the initial cohort. Two investigators reviewed each study and a third resolved study inclusion disagreements.Of 7371 clinical studies reviewed, 29 studies (0.4%, 7971 patients) met inclusion criteria. All gastric bypass studies (6 prospective cohorts, 5 retrospective cohorts) and sleeve gastrectomy studies (2 retrospective cohorts) had 95% confidence intervals for the reported mean, median, or both exceeding 50% excess weight loss. This amount of excess weight loss occurred in 31% of gastric band studies (9 prospective cohorts, 5 retrospective cohorts). The mean sample-size-weighted percentage of excess weight loss for gastric bypass was 65.7% (n?=?3544) vs 45.0% (n?=?4109) for gastric band. Nine studies measured comorbidity improvement. For type 2 diabetes (glycated hemoglobin <6.5% without medication), sample-size-weighted remission rates were 66.7% for gastric bypass (n?=?428) and 28.6% for gastric band (n?=?96). For hypertension (blood pressure <140/90 mm Hg without medication), remission rates were 38.2% for gastric bypass ( n?=?808) and 17.4% for gastric band (n?=?247). For hyperlipidemia (cholesterol <200 mg/dL, high-density lipoprotein >40 mg/dL, low-density lipoprotein <160 mg/dL, and triglycerides <200 mg/dL), remission rates were 60.4% for gastric bypass (n?=?477) and 22.7% for gastric band (n?=?97).Very few bariatric surgery studies report long-term results with sufficient patient follow-up to minimize biased results. Gastric bypass has better outcomes than gastric band procedures for long-term weight loss, type 2 diabetes control and remission, hypertension, and hyperlipidemia. Insufficient evidence exists regarding long-term outcomes for gastric sleeve resections.
Project description:INTRODUCTION:Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE). METHODS AND ANALYSIS:The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ?40?kg/m2 or ?35?kg/m2 with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50?kg/m2 will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group. ETHICS AND DISSEMINATION:The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:NCT03610256.
Project description:BACKGROUND:Apolipoprotein A-IV (ApoA-IV) has been shown to be involved in obesity and diabetes pathogenesis in animal studies, but its role in humans is uncertain. OBJECTIVES:The objective of this study was to determine the relation of ApoA-IV with changes in glucose metabolism and weight after bariatric surgery. SETTING:University Hospital. METHODS:The patients (n = 49) included lean controls (n = 8) and patients before and after a mean of 7 months after laparoscopic adjustable gastric banding (LAGB, n = 12), laparoscopic Roux-en-Y gastric bypass (RYGB, n = 22), or laparoscopic sleeve gastrectomy (SG, n = 11). ApoA-IV and other hormone assays were performed in the fasting and the postprandial state. Pearson's correlation analyses controlled for baseline BMI and percent excess weight loss (EWL) were used to determine relationships between ApoA-IV levels and insulin resistance (HOMA-IR). RESULTS:With all bariatric procedures combined, the change in ApoA-IV [533 versus 518 microg/L, P = .813] or ApoA-IV area under the curve (AUC - 1072 versus 1042, P = .939) was not significant. None of the surgeries individually affected levels of fasting or ApoA-IV AUC. Bariatric surgery resulted in a decrease in HOMA-IR (5.3 versus 2.0, P<.001). In the RYGB group, higher baseline ApoA-IV levels correlated with decrease in HOMA-IR [r = -.6, P = .008]. This relationship was independent of EWL and was not observed in the LAGB or SG group. There was no association of ApoA-IV levels with EWL, insulin secretion, Peptide-YY, or leptin levels. CONCLUSION:Preoperative ApoA-IV levels, rather than changes in levels, positively correlate with improvements in insulin sensitivity independent of weight loss after RYGB.
Project description:<h4>Introduction</h4>Management of severe reflux after sleeve gastrectomy (SG) usually requires converting to Roux-en-y gastric bypass (RYGB). We present a case of managing this problem using the LINX<sup>®</sup> system.<h4>Presentation of case</h4>In February 2015, we performed a laparoscopic placement of LINX<sup>®</sup> system to treat severe reflux after sleeve gastrectomy on a 25-year-old female. The operative time was 47min. There were no intra or postoperative complications. The hospital stay was one day. The postoperative UGI showed no reflux. Ten days after surgery her Quality of life score (QOL) changed from 64/75 to 7/75 after the LINX<sup>®</sup> placement. One year later the patient continued to enjoy no reflux and stayed off medication.<h4>Discussion</h4>Reflux after sleeve gastrectomy is usually managed by conversion to RYGB by most surgeons. This case report opens the door for an alternative management of this problem while maintaining the original sleeve gastrectomy. This technique is reasonably easy to perform in comparison to the conversion to RYGB with less potential post-operative complications. A one year follow up showed good control of reflux without medication.<h4>Conclusion</h4>Laparoscopic placement of the LINX<sup>®</sup> system to correct severe reflux after sleeve gastrectomy is a safe alternative procedure to conversion to a RYGB.