Dataset Information

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

ABSTRACT:

Importance

Laparoscopic sleeve gastrectomy (LSG) is currently the predominant bariatric procedure, although long-term weight loss and quality-of-life (QoL) outcomes compared with laparoscopic Roux-en-Y gastric bypass (LRYGB) are lacking.

Objective

To determine weight loss equivalence of LSG and LRYGB at 7 years in patients with morbid obesity, with special reference to long-term QoL.

Design, setting, and participants

The SLEEVE vs byPASS (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted between March 10, 2008, and June 2, 2010, in Finland. The trial enrolled 240 patients with morbid obesity aged 18 to 60 years who were randomized to undergo either LSG or LRYGB with a 7-year follow-up (last follow-up, September 26, 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 4, 2018, to November 8, 2019.

Interventions

Laparoscopic sleeve gastrectomy (n = 121) or LRYGB (n = 119).

Main outcomes and measures

The primary end point was percentage excess weight loss (%EWL) at 5 years. Secondary predefined follow-up time points were 7, 10, 15, and 20 years, with included 7-year secondary end points of QoL and morbidity. Disease-specific QoL (DSQoL; Moorehead-Ardelt Quality of Life questionnaire [range of scores, -3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at 1, 3, 5, and 7 years postoperatively concurrently with weight loss.

Results

Of 240 patients (167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline body mass index, 45.9 [6.0]), 182 (75.8%) completed the 7-year follow-up. The mean %EWL was 47% (95% CI, 43%-50%) after LSG and 55% (95% CI, 52%-59%) after LRYGB (difference, 8.7 percentage units [95% CI, 3.5-13.9 percentage units]). The mean (SD) DSQoL total score at 7 years was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (P = .63), and the median HRQoL total score was 0.88 (interquartile range [IQR], 0.78-0.95) after LSG and 0.87 (IQR, 0.78-0.95) after LRYGB (P = .37). Greater weight loss was associated with better DSQoL (r = 0.26; P < .001). At 7 years, mean (SD) DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; P < .001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; P = .07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (P = .42).

Conclusions and relevance

This study found that LSG and LRYGB were not equivalent in %EWL at 7 years. Laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than LSG, but the difference was not clinically relevant based on the prespecified equivalence margins. There was no difference in long-term QoL between the procedures. Bariatric surgery was associated with significant long-term DSQoL improvement, and greater weight loss was associated with better DSQoL.

Trial registration

ClinicalTrials.gov Identifier: NCT00793143.

SUBMITTER: Gronroos S

PROVIDER: S-EPMC7726698 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceLaparoscopic 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.ObjectiveTo 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 participantsThe 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).InterventionsLaparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119).Main outcomes and measuresThe 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.ResultsAmong 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 relevanceAmong 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 registrationclinicaltrials.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:BackgroundPregnancies occurring after bariatric surgery are associated with various perinatal complications. However, there may be differences in the type of perinatal complications occurring after different methods of bariatric surgery. The aim of the current study was to compare adverse perinatal outcomes in pregnant women following Roux-en-Y Gastric Bypass (RYGB) vs. Sleeve Gastrectomy (SG).MethodsA systematic database search was performed in PubMed, Embase, Scopus and CINAHL. Observational studies comparing perinatal outcomes post-bariatric (RYGB and SG) surgery to pregnancies without prior surgery were selected. Outcomes of interest were: maternal body mass index (BMI) at the time of conception, mode of delivery, time from surgery to conception, birth weight, gestational age and intrauterine fetal death. Article selection, risk of bias assessment and data extraction, were performed by two authors. The study protocol was published in its revised form in PROSPERO, registration number: CRD42021234480.ResultsA total of 3201 records were extracted. After duplicates were removed, 3143 records were screened for inclusion. Six studies fitted the selection criteria, of which four studies were RYGB and two SG (1100 post-RYGB vs. 209 post-SG). For the included studies, higher incidence of both SGA (22.9%, 11.9%, 14.2%) and LGA (4.2%, 4.8%, 1.7%) in SG compared to Roux-en-Y (SGA: 8.8%, 7.7%, 11.5%, 8.3% and LGA: 3.4%, 0.7%) were observed. SG had a shorter surgery to conception interval as compared to RYGB. Risk of bias assessment was moderate to serious for the studies included in the review, with bias in selection of participants being the major reason.ConclusionOur systematic review demonstrated no major differences in BMI, mode of delivery, birthweight, gestational age, or rates of intrauterine death between women having undergone RYGB vs. SG. The rate of SGA and LGA births were higher in the SG group, but this group also had a shorter surgery to conception interval. Future studies are indicated to counsel women of reproductive age on the most appropriate type of bariatric surgery that is associated with the best perinatal outcomes.

Project description:ImportanceLong-term results from randomized clinical trials comparing laparoscopic sleeve gastrectomy (LSG) with laparoscopic Roux-en-Y-gastric bypass (LRYGB) are limited.ObjectiveTo compare long-term outcomes of weight loss and remission of obesity-related comorbidities and the prevalence of gastroesophageal reflux symptoms (GERD), endoscopic esophagitis, and Barrett esophagus (BE) after LSG and LRYGB at 10 years.Design, setting, and participantsThis 10-year observational follow-up evaluated patients in the Sleeve vs Bypass (SLEEVEPASS) multicenter equivalence randomized clinical trial comparing LSG and LRYGB in the treatment of severe obesity in which 240 patients aged 18 to 60 years with median body mass index of 44.6 were randomized to LSG (n = 121) or LRYGB (n = 119). The initial trial was conducted from April 2008 to June 2010 in Finland, with last follow-up on January 27, 2021.InterventionsLSG or LRYGB.Main outcomes and measuresThe primary end point was 5-year percentage excess weight loss (%EWL). This current analysis focused on 10-year outcomes with special reference to reflux and BE.ResultsAt 10 years, of 240 randomized patients (121 randomized to LSG and 119 to LRYGB; 167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline BMI, 45.9 [6.0]), 2 never underwent surgery and there were 10 unrelated deaths; 193 of the remaining 228 patients (85%) completed follow-up on weight loss and comorbidities, and 176 of 228 (77%) underwent gastroscopy. Median (range) %EWL was 43.5% (2.1%-109.2%) after LSG and 50.7% (1.7%-111.7%) after LRYGB. Mean estimate %EWL was not equivalent between the procedures; %EWL was 8.4 (95% CI, 3.1-13.6) higher in LRYGB. After LSG and LRYGB, there was no statistically significant difference in type 2 diabetes remission (26% and 33%, respectively; P = .63), dyslipidemia (19% and 35%, respectively; P = .23), or obstructive sleep apnea (16% and 31%, respectively; P = .30). Hypertension remission was superior after LRYGB (8% vs 24%; P = .04). Esophagitis was more prevalent after LSG (31% vs 7%; P < .001) with no statistically significant difference in BE (4% vs 4%; P = .29). The overall reoperation rate was 15.7% for LSG and 18.5% for LRYGB (P = .57).Conclusions and relevanceAt 10 years, %EWL was greater after LRYGB and the procedures were not equivalent for weight loss, but both LSG and LRYGB resulted in good and sustainable weight loss. Esophagitis was more prevalent after LSG, but the cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures.Trial registrationClinicalTrials.gov Identifier: NCT00793143.

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:ImportanceData on the long-term health care expenditures associated with bariatric surgery consisting of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy are lacking.ObjectiveTo compare 4-year health care expenditures after RYGB vs sleeve gastrectomy, identify factors independently associated with 4-year health care expenditures, and compare the procedures in terms of subsequent hospitalizations, bariatric procedures, and all-cause mortality.Design, setting, and participantsIn this propensity score-matched cohort study, all residents of Ontario, Canada, who underwent publicly funded surgery with RYGB (n = 6301) or sleeve gastrectomy (n = 926) from March 1, 2010, to March 31, 2015, and consented to participate in the Ontario Bariatric Registry were eligible for the study. Follow-up was completed on March 31, 2019, and data were analyzed from May 5, 2020, to May 20, 2021.InterventionsRYGB and sleeve gastrectomy.Main outcomes and measuresPublicly funded health care expenditures, subsequent hospitalizations, bariatric procedures, and mortality during the 4 years after RYGB or sleeve gastrectomy.ResultsThe 1:1 matched study cohorts consisted of 1624 patients (812 per cohort) with a mean (SD) age of 48.0 (10.6) years, and 1242 women (76.5%). The mean body mass index (calculated as weight in kilograms divided by height in square meters) was 51.9 (8.3) for the RYGB cohort and 51.9 (8.9) for the sleeve gastrectomy cohort. The 4-year cumulative costs were not statistically significantly different between RYGB and sleeve gastrectomy (mean [SD], $33 682 [$31 169] vs $33 948 [$32 633], respectively; P = .86). Having a history of coronary artery disease was associated with a 35% increase in overall health care expenditures; chronic kidney disease, a 54% increase; and mental health admissions, a 67% increase. There were no statistically significant differences in all-cause mortality between RYGB and sleeve gastrectomy (1.5% vs 2.2%, respectively; P = .26) or the total number of hospitalizations (754 vs 669, respectively; P = .11) during the 4-year follow-up period. However, nonelective hospitalizations occurred more frequently with RYGB vs sleeve gastrectomy (472 vs 339, respectively; P = .002). Roux-en-Y gastric bypass was associated with relatively fewer subsequent bariatric procedures during the 4-year follow-up period (9 vs 40, respectively; P < .001).Conclusions and relevanceIn this Canadian population-based study, key results indicated that 4-year health care expenditures, all-cause mortality, and number of hospital admissions associated with RYGB did not significantly differ from those for sleeve gastrectomy. The rate of subsequent bariatric surgery was lower with RYGB. This study identified important patient-level drivers of health care expenditures that need to be further investigated.