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Is weight loss equivalence and improvement of quality of life similar at 7 years after laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients with morbid obesity?
In this randomized clinical trial of 240 patients with morbid obesity, the 7-year mean percentage excess weight loss was 47% after LSG vs 55% after LRYGB, a difference that did not meet prespecified criteria for equivalence; greater weight loss was associated with better quality of life. Disease-specific quality of life and general quality of life were similar.
Weight loss was not equivalent between LSG and LRYGB because somewhat greater weight loss was achieved after LRYGB; quality of life improvement was similar after both procedures.
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.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT00793143
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: September 18, 2020.
Published Online: December 9, 2020. doi:10.1001/jamasurg.2020.5666
Corresponding Author: Paulina Salminen, MD, PhD, Division of Digestive Surgery and Urology, Turku University Hospital, PO Box 52, 20520 Turku, Finland (firstname.lastname@example.org).
Author Contributions: Drs Grönroos and Salminen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Grönroos, Helmiö, Hurme, Ovaska, Leivonen, Peromaa-Haavisto, Salminen.
Acquisition, analysis, or interpretation of data: Grönroos, Helmiö, Juuti, Tiusanen, Hurme, Löyttyniemi, Leivonen, Mäklin, Sintonen, Sammalkorpi, Nuutila, Salminen.
Drafting of the manuscript: Grönroos, Tiusanen, Löyttyniemi, Mäklin, Nuutila, Salminen.
Critical revision of the manuscript for important intellectual content: Grönroos, Helmiö, Juuti, Hurme, Löyttyniemi, Ovaska, Leivonen, Peromaa-Haavisto, Mäklin, Sintonen, Sammalkorpi, Nuutila, Salminen.
Statistical analysis: Grönroos, Hurme, Löyttyniemi, Mäklin, Sintonen, Salminen.
Obtained funding: Salminen.
Administrative, technical, or material support: Grönroos, Helmiö, Juuti, Sammalkorpi, Salminen.
Supervision: Helmiö, Ovaska, Nuutila, Salminen.
Conflict of Interest Disclosures: Dr Grönroos reported receiving grants from the government research foundation (EVO) during the conduct of the study. Dr Helmiö reported receiving grants from Finnish government research funding, Turku University Foundation, Finnish Medical Foundation, and Gastrointestinal Disorders Research Foundation during the conduct of the study. Dr Sintonen reported being the developer of the 15D and obtaining royalties from its electronic versions. Dr Salminen reported receiving grants from the government research foundation (EVO) during the conduct of the study; and personal fees from Orion Pharma, Merck, and Lilly outside the submitted work. No other disclosures were reported.
Funding/Support: The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation (Dr Salminen), by a government research grant from the EVO Foundation awarded to Turku University Hospital (Drs Salminen and Helmiö), and by the Gastroenterological Research Foundation (Dr Helmiö).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We wish to pay our respects to and thank our colleague Mikael Victorzon, MD, PhD, Department of Surgery, University of Turku, and Vaasa Central Hospital, Vaasa, Finland who was involved in this trial, but passed away before this work was submitted.
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