腹腔镜袖状胃切除术与腹腔镜Roux-en-Y胃旁路术对病态肥胖患者体重减轻的影响：SM-BOSS随机临床试验
Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.
作者信息
Peterli Ralph, Wölnerhanssen Bettina Karin, Peters Thomas, Vetter Diana, Kröll Dino, Borbély Yves, Schultes Bernd, Beglinger Christoph, Drewe Jürgen, Schiesser Marc, Nett Philipp, Bueter Marco
机构信息
Department of Surgery, St Claraspital, Basel, Switzerland.
Department of Clinical Research, St Claraspital, Basel, Switzerland.
出版信息
JAMA. 2018 Jan 16;319(3):255-265. doi: 10.1001/jama.2017.20897.
IMPORTANCE
Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown.
OBJECTIVE
To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events.
DESIGN, SETTING, AND PARTICIPANTS: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period.
INTERVENTIONS
Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110).
MAIN OUTCOMES AND MEASURES
The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events.
RESULTS
Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass.
CONCLUSIONS AND RELEVANCE
Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00356213.
重要性
袖状胃切除术在病态肥胖治疗中的应用日益广泛，但其与标准的 Roux-en-Y 胃旁路手术相比的长期疗效尚不清楚。
目的
确定袖状胃切除术和 Roux-en-Y 胃旁路手术在体重减轻、合并症变化、生活质量提高以及不良事件方面是否存在差异。
设计、地点和参与者：瑞士多中心旁路或袖状胃研究（SM-BOSS）是一项两组随机试验，于 2007 年 1 月至 2011 年 11 月进行（2017 年 3 月进行最后一次随访）。在瑞士 4 个减肥手术中心接受减肥手术评估的 3971 名病态肥胖患者中，217 名患者入组并随机分配接受袖状胃切除术或 Roux-en-Y 胃旁路手术，随访期为 5 年。
干预措施
患者被随机分配接受腹腔镜袖状胃切除术（n = 107）或腹腔镜 Roux-en-Y 胃旁路手术（n = 110）。
主要结局和测量指标
主要终点是体重减轻，以超重体重指数（BMI）损失百分比表示。探索性终点是合并症和不良事件的变化。
结果
在 217 名患者（平均年龄 45.5 岁；72%为女性；平均 BMI 为 43.9）中，205 名（94.5%）完成了试验。5 年时超重 BMI 损失无显著差异：袖状胃切除术为 61.1%，Roux-en-Y 胃旁路手术为 68.3%（绝对差异为 -7.18%；95%CI 为 -14.30%至 -0.06%；经多重比较调整后 P = 0.22）。Roux-en-Y 胃旁路手术后胃反流缓解的发生率（60.4%）高于袖状胃切除术后（25.0%）。袖状胃切除术后胃反流恶化（症状更多或治疗增加）的发生率（31.8%）高于 Roux-en-Y 胃旁路手术后（6.3%）。袖状胃切除术后再次手术或干预的患者有 16/101（15.8%），Roux-en-Y 胃旁路手术后为 23/104（22.1%）。
结论和相关性
在病态肥胖患者中，腹腔镜袖状胃切除术和腹腔镜 Roux-en-Y 胃旁路手术术后 5 年的超重 BMI 损失无显著差异。
试验注册
clinicaltrials.gov 标识符：NCT00356213。
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