Dataset Information

Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing SG and RYGB has been performed in adolescents. OBJECTIVE:Determine whether SG is non-inferior to RYGB in terms of total body weight (TBW) loss in adolescents with severe obesity. METHODS:A multicenter randomized controlled non-inferiority trial. Two hundred sixty-four adolescents aged 13-17 (Tanner stage ?IV) with severe obesity (corrected for age and sex) will be included. Adolescents agreeing to participate will be randomized to either RYGB or SG. The primary outcome is the proportion of participants achieving 20% TBW loss at 3 years postoperatively. Secondary outcomes include (i) change in body weight, body mass index (BMI) and BMI standard deviation score, (ii) incidence of adverse health events and need for additional surgical intervention, (iii) resolution of obesity-related comorbidities, (iv) prevalence of cardio metabolic risk factor measures, (v) bone health measures and incidence of bone fractures, (vi) quality of life including psychosocial health, patient satisfaction and educational attainment and (vii) body composition. Follow-up will extend into the long term. RESULTS:Not applicable. DISCUSSION:This study will, to our knowledge, be the first randomized controlled trial comparing SG and RYGB in adolescents with severe obesity. TRIAL REGISTRATION:The trial is registered at the Netherlands Trial Register on July 26th, 2018 - NTR7191 - https://www.trialregister.nl/trial/7191 (protocol version 5.0 - February 3th 2020).

SUBMITTER: Bonouvrie DS

PROVIDER: S-EPMC7268239 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.

Bonouvrie Daniëlle S DS Beamish Andrew J AJ Leclercq Wouter K G WKG van Mil Edgar G A H EGAH Luijten Arijan A P M AAPM Hazebroek Eric J EJ Vreugdenhil Anita C E ACE Olbers Torsten T van Dielen François M H FMH

BMC surgery 20200603 1

<h4>Background</h4>Recent data support the use of bariatric surgery in adolescents with severe obesity following unsuccessful non-surgical treatments. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) have demonstrated reasonably similar weight loss and reduction of obesity related comorbidities in randomized trials in adults. SG has internationally become the most commonly used procedure in adolescents, yet long-term outcome data are lacking. No randomized controlled trial comparing S ...[more]

PMID: 32493359

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Project description:Among a US cohort followed 5 years after Roux-en-Y gastric bypass or sleeve gastrectomy, cumulative incidence of marriage and separation/divorce were 18% among unmarried (N=614) and 13% among married (N=827) participants, respectively. Preoperative predictors of marriage included younger age, college degree, lower BMI and cohabitating or being separated (versus single).ObjectivesTo describe changes in marital status following Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).BackgroundSpousal encouragement and finding a life partner are self-reported motivators for undergoing bariatric surgery.MethodsThis study included 1441 US adults enrolled in a 6-center prospective cohort study who underwent RYGB or SG (2006-2009) and self-reported marital status preoperatively and annually postoperatively for ≤5 years. Time to change in marital status was analyzed with Kaplan-Meier estimates of cumulative incidence and Cox proportional-hazard models.ResultsPreoperative, 57% of participants (79% female, median age 47 years, median body mass index [BMI] 47 kg/m2) were married, 5% cohabitating, 4% separated, 15% divorced, 2% widowed, and 17% always single. The 5-year cumulative incidence of marriage among unmarried participants (N = 614) was 18%. Cohabitating (hazard ratios [HR] = 5.25) or being separated (HR = 3.03) versus always single, younger age (HR = 1.69/10 years), having a college degree versus ≤high school (HR = 2.36), lower BMI (HR = 1.54/10kg/m2), and fewer depressive symptoms (HR = 1.47/10 Beck Depression Inventory points) preoperative independently predicted (P < 0.05) higher chance of marriage. The 5-year cumulative incidence of separation/divorce among married participants (N = 827) was 13%. Female sex (HR = 2.08), younger age (HR = 1.84/10 years), household income <$25,000 versus ≥$100,000 (HR = 2.48), smoking (HR = 1.76), and sexual desire ≥once/week versus never (HR = 2.12) preoperative independently predicted (P ≤ 0.05) separation/divorce.ConclusionsAmong a cohort of US adults, the majority did not change marital status within 5 years following RYGB or SG. Cumulative incidence of marriage and separation/divorce was 18% among unmarried and 13% among married participants, respectively. Several preoperative predictors of marriage and separation/divorce were identified.

Project description:Importance: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. Objective:To assess the association of 3 common types of bariatric surgery compared with nonsurgical treatment with mortality and other clinical outcomes among obese patients. Design, Setting, and Participants: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. Exposures: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). Main Outcomes and Measures: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. Results: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. Conclusions and Relevance: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: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.

Dataset Information

Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.

Publications

Laparoscopic roux-en-Y gastric bypass versus sleeve gastrectomy for teenagers with severe obesity - TEEN-BEST: study protocol of a multicenter randomized controlled trial.

Similar Datasets

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