Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity The SLEEVEPASS Randomized Clinical Trial
Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity The SLEEVEPASS Randomized Clinical Trial
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DOI：
10.1001/jama.2017.20313
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发表时间：
2018-01-16
影响因子：
120.7
通讯作者：
Victorzon, Mikael
中科院分区：
文献类型：
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作者：
Salminen, Paulina;Helmio, Mika;Victorzon, Mikael
重要性 与腹腔镜 Roux-en-Y 胃绕道手术相比，尽管缺乏长期结果，但腹腔镜袖状胃切除术治疗病态肥胖的疗效已大幅增加。 目的 确定腹腔镜袖状胃切除术和腹腔镜 Roux-en-Y 胃绕道手术对于病态肥胖患者 5 年体重减轻是否等效。 设计、设置、 袖套与绕道 (SLEEVEPASS) 多中心、多位外科医生、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 名年龄在 18 至 60 岁之间的病态肥胖患者，他们被随机分配接受袖状胃切除术或胃绕道术，并进行 5 年随访（最后一次随访，2015 年 10 月 14 日）。 干预措施 腹腔镜袖状胃切除术 (n = 121) 或腹腔镜 Roux-en-Y 胃绕道术 (n = 119)。 主要结果和措施 主要措施 终点是通过超重减轻百分比来评估体重减轻。胃绕道术和袖状胃切除术之间体重减轻差异的临床意义的预先设定的等价界为-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 240 名随机患者中（平均年龄，48 [SD，9] 岁；平均基线体重指数，45.9，[SD，6.0]；69.6% 为女性），80.4% 完成了 5 年随访。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 年估计的平均体重减轻百分比为 49%（95% CI，45%-52%），胃绕道术后为 57%（95% CI，53%-61%）（差异为 8.2 个百分比单位 [95% CI，3.2%-13.2%]，胃绕道组更高），不符合等效标准。袖状胃切除术后 2 型糖尿病完全或部分缓解率为 37% (n = 15/41)，胃绕道术后为 45% (n = 18/40) (P > .99)。袖状胃切除术后有 47%(n = 14/30) 停止治疗血脂异常药物，胃绕道手术后有 60%(n = 24/40) 停止治疗血脂异常药物 (P = .15)，而停止治疗高血压药物则分别有 29% (n = 20/68) 和 51%(n = 37/73) (P = .02)。各组之间的生活质量没有统计学上的显着差异 (P = .85)，并且没有与治疗相关的死亡率。 5 年时，袖状胃切除术的总体发病率为 19% (n = 23)，胃绕道手术的总体发病率为 26%(n = 31) (P = .19)。结论和相关性 在病态肥胖患者中，与使用腹腔镜 Roux-en-Y 胃绕道术相比，在超重减轻百分比方面不符合等效标准 5岁时。尽管与袖状胃切除术相比，胃绕道手术与 5 年时体重减轻的百分比更高有关，但根据预先指定的等效边界，差异并不具有统计学意义。
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.