Kraljevic Marko, Süsstrunk Julian, Wölnerhanssen Bettina Karin, Peters Thomas, Bueter Marco, Gero Daniel, Schultes Bernd, Poljo Adisa, Schneider Romano, Peterli Ralph
Clarunis, Department of Visceral Surgery, University Digestive Health Care Center, St Clara Hospital and University Hospital, Basel, Switzerland.
Metabolic Research, St Clara Research, St Clara Hospital, Basel, Switzerland.
JAMA Surg. 2025 Apr 1;160(4):369-377. doi: 10.1001/jamasurg.2024.7052.
Reports on long-term outcomes from randomized clinical trials comparing laparoscopic sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are scarce.
To compare long-term weight and metabolic outcomes, reoperation rates, and quality of life for patients undergoing SG vs RYGB at 10 years and beyond.
DESIGN, SETTING, AND PARTICIPANTS: The SM-BOSS (Swiss Multicenter Bypass or Sleeve Study) randomized clinical trial was conducted from January 2007 to November 2011 at 4 bariatric centers in Switzerland. (The last follow-up was obtained in July 2023.) A total of 3971 patients with severe obesity were assessed, and 217 patients were enrolled and randomized to undergo SG or RYGB.
Laparoscopic SG or RYGB.
The primary outcome of the SM-BOSS trial was the percentage excess body mass index loss (%EBMIL) at 5 years. The present study reports on the long-term weight and metabolic outcomes at 10 years and beyond, including changes in weight and obesity-related diseases, reoperation rates, and quality of life.
Of 217 patients randomized to undergo SG or RYGB, mean (SD) age was 42.5 (11.1) years, mean (SD) baseline BMI was 43.9 (5.3), and 156 patients (71.9%) were female. Of 217 patients, 110 patients were randomized to RYGB and 107 to SG. Complete 10-year follow-up is available for 65.4% of patients. In the intention-to-treat population, mean (SD) %EBMIL was 60.6% (25.9) after SG and 65.2% (26.0) after RYGB (P = .29). Patients who underwent SG had significantly higher conversion rates because of insufficient weight reduction or reflux compared to RYGB (29.9% vs 5.5%; P < .001). Patients undergoing RYGB had significantly higher mean (SD) %EBMIL compared to SG after 10 years in the per-protocol (PP) population (65.9% [26.3] vs 56.1% [25.2]; P = .048). However, mean (SD) percentage total weight loss was not significantly different between groups (RYGB: 27.7% [10.8]; SG: 25.5% [15.1]; P = .37). SG patients had significantly more de novo gastroesophageal reflux (GERD) compared with RYGB (P = .02).
In the SM-BOSS randomized clinical trial, RYGB led to significantly higher %EBMIL in the PP population compared with SG beyond 10 years of follow-up, with better results for GERD. Patients undergoing SG experienced a significantly higher number of conversions to different anatomy compared with RYGB.
ClinicalTrials.gov Identifier NCT00356213.
比较腹腔镜袖状胃切除术（SG）和Roux-en-Y胃旁路术（RYGB）的随机临床试验的长期结果报告很少。
比较接受SG与RYGB手术10年及以后患者的长期体重和代谢结果、再次手术率和生活质量。
设计、地点和参与者：SM-BOSS（瑞士多中心旁路或袖状胃研究）随机临床试验于2007年1月至2011年11月在瑞士的4个减肥中心进行。（最后一次随访于2023年7月获得。）共评估了3971例重度肥胖患者，217例患者被纳入并随机接受SG或RYGB手术。
腹腔镜SG或RYGB。
SM-BOSS试验的主要结局是5年时的超重体重指数降低百分比（%EBMIL）。本研究报告了10年及以后的长期体重和代谢结果，包括体重和肥胖相关疾病的变化、再次手术率和生活质量。
在217例随机接受SG或RYGB手术的患者中，平均（标准差）年龄为42.5（11.1）岁，平均（标准差）基线BMI为43.9（5.3），156例患者（71.9%）为女性。在217例患者中，110例患者被随机分配接受RYGB手术，107例接受SG手术。65.4%的患者有完整的10年随访数据。在意向性治疗人群中，SG术后平均（标准差）%EBMIL为60.6%（25.9），RYGB术后为65.2%（26.0）（P = 0.29）。与RYGB相比，接受SG手术的患者因减重不足或反流导致的转换率显著更高（29.9%对5.5%；P < 0.001）。在符合方案（PP）人群中，10年后接受RYGB手术的患者的平均（标准差）%EBMIL显著高于接受SG手术的患者（65.9% [26.3]对56.1% [25.2]；P = 0.048）。然而，两组间平均（标准差）总体重减轻百分比无显著差异（RYGB：27.7% [10.8]；SG：25.5% [15.1]；P = 0.37）。与RYGB相比，SG患者新发胃食管反流（GERD）显著更多（P = 0.02）。
在SM-BOSS随机临床试验中，随访超过10年时，与SG相比，RYGB在PP人群中导致显著更高的%EBMIL，且GERD结果更好。与RYGB相比，接受SG手术的患者转换为不同解剖结构的次数显著更多。
ClinicalTrials.gov标识符NCT00356213。
