Long-term weight change and health outcomes for sleeve gastrectomy (SG) and matched Roux-en-Y gastric bypass (RYGB) participants in the Longitudinal Assessment of Bariatric Surgery (LABS) study.
ABSTRACT: 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: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: 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: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:BACKGROUND AND OBJECTIVES:Severely obese adolescents harbor numerous cardiovascular disease risk factors (CVD-RFs), which improve after metabolic and bariatric surgery (MBS). However, predictors of change in CVD-RFs among adolescents have not yet been reported. METHODS:The Teen-Longitudinal Assessment of Bariatric Surgery study (NCT00474318) prospectively collected anthropometric and health status data on 242 adolescents undergoing MBS at 5 centers. Predictors of change in CVD-RFs (blood pressure, lipids, glucose homeostasis, and inflammation) 3 years after Roux-en-Y gastric bypass and vertical sleeve gastrectomy were examined. RESULTS:The mean (±SD) age of participants at baseline was 17 ± 1.6 years; 76% were girls, and 72% were white, with a median BMI of 51. Participants underwent Roux-en-Y gastric bypass (n = 161), vertical sleeve gastrectomy (n = 67), or adjustable gastric banding (n = 14). Increasing weight loss was an independent predictor of normalization in dyslipidemia, elevated blood pressure (EBP), hyperinsulinemia, diabetes, and elevated high-sensitivity C-reactive protein. Older participants at time of surgery were less likely to resolve dyslipidemia compared with younger participants, whereas girls were more likely than boys to demonstrate improvements in EBP. Even those participants without frank dyslipidemia or EBP at baseline showed significant improvements in lipid and blood pressure values over time. CONCLUSIONS:Numerous CVD-RFs improve among adolescents undergoing MBS. Increased weight loss, female sex, and younger age predict a higher probability of resolution of specific CVD-RFs. The elucidation of predictors of change in CVD-RFs may lead to refinements in patient selection and optimal timing of adolescent bariatric surgery designed to improve clinical outcomes.
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:Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
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:OBJECTIVE:Roux-en-Y gastric bypass surgery and vertical sleeve gastrectomy (VSG) are the most commonly performed bariatric procedures. Whereas studies report new-onset alcohol misuse following Roux-en-Y gastric bypass, the impact of VSG on alcohol intake is less clear. Hedonic feeding, alcohol drinking, and hypothalamic obesity-related gene expression following VSG were evaluated. METHODS:Male Long-Evans rats underwent VSG or sham surgery. To evaluate hedonic feeding, rats received a high-fat diet following behavioral satiation on chow. Alcohol (5%-10% v/v) drinking was assessed in a two-bottle choice paradigm. Finally, polymerase chain reaction array evaluated gene expression. RESULTS:VSG induced moderate but significant weight loss. Sham rats significantly escalated high-fat diet intake following behavioral satiation, an effect significantly reduced in VSG rats. A moderate decrease in alcohol intake was observed in VSG rats at low (5%) alcohol concentration. However, overall, no significant between-group differences were evident. Key hypothalamic orexigenic transcripts linked to stimulation of food and alcohol intake were significantly decreased in VSG rats. CONCLUSIONS:VSG attenuated hedonic feeding without impacting alcohol drinking, an effect potentially mediated by alterations in genetic information flow within the hypothalamus. Importantly, these data highlight VSG as an effective bariatric procedure with a potentially reduced risk of developing alcohol use disorder.
Project description:<h4>Background</h4>Bariatric surgery centres of excellence are relatively new in Canada and were first started in Ontario in 2009. This study presents short-term outcomes of Canada's largest bariatric collaborative, from Ontario, during its first 3 years.<h4>Methods</h4>We performed a population-based cohort study that included all patients (age ? 18) who received a Roux-en-Y gastric bypass or sleeve gastrectomy for the purpose of weight loss from March 2009 to April 2012 within Ontario. Data were derived from the Canadian Institute for Health Information Discharge Abstract and Hospital Morbidity Databases. Primary outcomes included short-term overall complication rate, reoperation rate, anastomotic leak rate and death. Hierarchical logistic regression was used to identify risk factors for overall complications. A median odds ratio (OR) was used to compare risk-adjusted complication rates across centres of excellence.<h4>Results</h4>A total of 5007 procedures (91.7% Roux-en-Y gastric bypass, 8.3% sleeve gastrectomy) were performed during the 3-year study period, with an overall complication rate of 11.7% (95% confidence interval [CI] 10.8%-12.6%). The leak rate was 0.84% (95% CI 0.61%-1.13%), the reoperation rate was 4.6% (95% CI 4.0%-5.2%) and mortality was 0.16% (95% CI 0.07%-0.31%). Male sex, chronic kidney disease and osteoarthritis were identified as risk factors for overall complications (<i>p</i> value < 0.05). The median ORs across centres of excellence, calculated for both overall complications and reoperation rate, were 1.76 and 1.49, respectively.<h4>Interpretation</h4>Bariatric surgery within Ontario has similar short-term outcomes to those of other major world centres. The variability of outcomes within centres of excellence highlights areas for program quality improvement.
Project description:BACKGROUND:Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. METHODS:We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. RESULTS:Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P=0.01, adjusted P=0.03, P=0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P=0.03, adjusted P=0.07, P=0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P=0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (-23%, -19%, and -5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (-40%, -29%, and -8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (-35%, -34%, and -13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. CONCLUSIONS:Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia. (Funded by Ethicon Endo-Surgery and others; STAMPEDE ClinicalTrials.gov number, NCT00432809 .).