Importance Laparoscopic 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. Objective To 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 Participants The 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). Interventions Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). Main Outcomes and Measures The 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. Results Among 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 Relevance Among 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 Registration clinicaltrials.gov Identifier: NCT00793143

中文翻译：

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腹腔镜袖状胃切除术与腹腔镜 Roux-en-Y 胃绕道术对病态肥胖患者 5 年体重减轻的影响

重要性 尽管与腹腔镜 Roux-en-Y 胃旁路术相比缺乏长期结果，但腹腔镜袖状胃切除术治疗病态肥胖的人数已大幅增加。目的 确定腹腔镜袖状胃切除术和腹腔镜 Roux-en-Y 胃绕道术对病态肥胖患者 5 年减重的效果是否相同。设计、设置和参与者 Sleeve vs Bypass (SLEEVEPASS) 多中心、多外科医生、开放标签、随机临床等效性试验于 2008 年 3 月至 2010 年 6 月在芬兰进行。该试验招募了 240 名 18 至 60 岁的病态肥胖患者，他们被随机分配接受袖状胃切除术或胃绕道手术，随访期为 5 年（最后一次随访，2015 年 10 月 14 日）。干预 腹腔镜袖状胃切除术（n = 121）或腹腔镜 Roux-en-Y 胃旁路术（n = 119）。主要结果和测量主要终点是通过超重减轻百分比评估的体重减轻。胃绕道手术和袖状胃切除术之间体重减轻差异的临床意义的预设等效界限为 -9% 至 +9% 的超重减轻。次要终点包括合并症的解决、生活质量 (QOL) 的改善、所有不良事件（总体发病率）和死亡率。结果 在随机分配的 240 名患者中（平均年龄，48 [SD，9] 岁；平均基线体重指数，45.9，[SD，6.0]；69.6% 女性），80.4% 完成了 5 年随访。在基线时，42.1% 患有 2 型糖尿病，34.6% 患有血脂异常，70.8% 患有高血压。袖状胃切除术后 5 年的估计平均超重减轻百分比为 49%（95% CI，45%-52%），胃绕道术后为 57%（95% CI，53%-61%）（差异，8.2 个百分点） [95% CI，3.2%-13.2%]，在胃绕道组中更高）并且不符合等效标准。袖状胃切除术后 37% (n = 15/41) 和胃绕道术后 45% (n = 18/40) 完全或部分缓解 2 型糖尿病 (P > .99)。袖状胃切除术后 47% (n = 14/30) 和胃绕道手术后 60% (n = 24/40) 停用治疗血脂异常的药物 (P = .15)，29% (n = 20/68) 停用高血压药物和 51% (n = 37/73) (P = .02)，分别。组间 QOL 无统计学显着差异 (P = .85)，且无治疗相关死亡率。5 年时，袖状胃切除术的总体发病率为 19% (n = 23)，胃绕道术的总体发病率为 26% (n = 31) (P = .19)。结论和相关性 在病态肥胖患者中，使用腹腔镜袖状胃切除术与使用腹腔镜 Roux-en-Y 胃绕道术相比，在 5 年超重减轻百分比方面不符合等效标准。尽管与袖状胃切除术相比，胃绕道术与 5 年时体重减轻的百分比更大有关，但根据预先指定的等效性界限，差异无统计学意义。试验注册clinicaltrials.gov 标识符：NCT00793143 使用腹腔镜袖状胃切除术与使用腹腔镜 Roux-en-Y 胃绕道术相比，在 5 年的超重减轻百分比方面不符合等效标准。尽管与袖状胃切除术相比，胃绕道术在 5 年时体重减轻的百分比更大，但根据预先指定的等效性界限，差异无统计学意义。试验注册clinicaltrials.gov 标识符：NCT00793143 使用腹腔镜袖状胃切除术与使用腹腔镜 Roux-en-Y 胃绕道术相比，在 5 年的超重减轻百分比方面不符合等效标准。尽管与袖状胃切除术相比，胃绕道术与 5 年时体重减轻的百分比更大有关，但根据预先指定的等效性界限，差异无统计学意义。试验注册clinicaltrials.gov 标识符：NCT00793143