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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 ObesityThe SLEEVEPASS Randomized Clinical Trial

Educational Objective
To identify whether weight loss equivalence and improvement of quality of life is similar at 7 years after laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity.

1 Credit CME

JAMA Surgery

Published Online: December 9, 2020

Original Investigation

Article Information and Disclosures

Sofia Grönroos, MD^1,2;

Mika Helmiö, MD, PhD^1,2;

Anne Juuti, MD, PhD³;

et al

Roosa Tiusanen, BM^1,2;

Saija Hurme, MSc⁴;

Eliisa Löyttyniemi, MSc⁴;

Jari Ovaska, MD, PhD^1,2;

Marja Leivonen, MD, PhD^3,5;

Pipsa Peromaa-Haavisto, MD, PhD^6,7;

Suvi Mäklin, MSc⁸;

Harri Sintonen, DSocSc⁹;

Henna Sammalkorpi, MD, PhD³;

Pirjo Nuutila, MD, PhD^10,11;

Paulina Salminen, MD, PhD^1,2,12

Author Affiliations

¹Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland
²Department of Surgery, University of Turku, Turku, Finland
³Abdominal Center, Department of Abdominal Surgery, Helsinki University Hospital, Helsinki, Finland
⁴Department of Biostatistics, University of Turku, Turku, Finland
⁵Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland
⁶Department of Surgery, Vaasa Central Hospital, Vaasa, Finland
⁷Department of Surgery, Hatanpää City Hospital, Tampere, Finland
⁸Centre for Health and Social Economics, National Institute for Health and Welfare, Helsinki, Finland
⁹Department of Public Health, University of Helsinki, Helsinki, Finland
¹⁰Department of Endocrinology, Turku University Hospital, Turku, Finland
¹¹Turku PET Centre, University of Turku, Turku, Finland
¹²Department of Surgery, Pori, Satakunta Central Hospital, Pori, Finland

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Key Points

Question 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?

Findings 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.

Meaning 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.

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

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Article Information

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 (paulina.salminen@tyks.fi).

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.

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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AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

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 ObesityThe SLEEVEPASS Randomized Clinical Trial

Using Quality-of-Life Measures to Determine the Ideal Bariatric Procedure

Common Weight Loss Surgeries’ Benefits Sustained at Year 7

AMA CME Accreditation 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 ObesityThe SLEEVEPASS Randomized Clinical Trial

Using Quality-of-Life Measures to Determine the Ideal Bariatric Procedure

Common Weight Loss Surgeries’ Benefits Sustained at Year 7

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