腹腔镜 Roux-en-Y 胃旁路术与腹腔镜袖状胃切除术：两项随机临床试验（SLEEVEPASS 和 SM-BOSS）合并数据的 5 年结果。

Laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy: 5-year outcomes of merged data from two randomized clinical trials (SLEEVEPASS and SM-BOSS).

机构信息

St Clara Research Ltd, St Clara Hospital, Basle, Switzerland.

University of Basle, Basle, Switzerland.

出版信息

Br J Surg. 2021 Jan 27;108(1):49-57. doi: 10.1093/bjs/znaa011.

DOI:10.1093/bjs/znaa011

PMID:33640917

Abstract

BACKGROUND

Laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB) are both effective surgical procedures to achieve weight reduction in patients with obesity. The trial objective was to merge individual-patient data from two RCTs to compare outcomes after LSG and LRYGB.

METHODS

Five-year outcomes of the Finnish SLEEVEPASS and Swiss SM-BOSS RCTs comparing LSG with LRYGB were analysed. Both original trials were designed to evaluate weight loss. Additional patient-level data on type 2 diabetes (T2DM), obstructive sleep apnoea, and complications were retrieved. The primary outcome was percentage excess BMI loss (%EBMIL). Secondary predefined outcomes in both trials included total weight loss, remission of co-morbidities, improvement in quality of life (QoL), and overall morbidity.

RESULTS

At baseline, 228 LSG and 229 LRYGB procedures were performed. Five-year follow-up was available for 199 of 228 patients (87.3 per cent) after LSG and 199 of 229 (87.1 per cent) after LRYGB. Model-based mean estimate of %EBMIL was 7.0 (95 per cent c.i. 3.5 to 10.5) percentage points better after LRYGB than after LSG (62.7 versus 55.5 per cent respectively; P < 0.001). There was no difference in remission of T2DM, obstructive sleep apnoea or QoL improvement; remission for hypertension was better after LRYGB compared with LSG (60.3 versus 44.9 per cent; P = 0.049). The complication rate was higher after LRYGB than LSG (37.2 versus 22.5 per cent; P = 0.001), but there was no difference in mean Comprehensive Complication Index value (30.6 versus 31.0 points; P = 0.859).

CONCLUSION

Although LRYGB induced greater weight loss and better amelioration of hypertension than LSG, there was no difference in remission of T2DM, obstructive sleep apnoea, or QoL at 5 years. There were more complications after LRYGB, but the individual burden for patients with complications was similar after both operations.

摘要

背景

腹腔镜袖状胃切除术（LSG）和 Roux-en-Y 胃旁路术（LRYGB）都是治疗肥胖患者体重减轻的有效手术方法。本试验的目的是合并两项随机对照试验的个体患者数据，以比较 LSG 和 LRYGB 后的结果。

方法

分析比较 LSG 和 LRYGB 的芬兰 SLEEVEPASS 和瑞士 SM-BOSS 两项 RCT 的 5 年结果。这两项原始试验都是为了评估减重效果而设计的。还额外检索了关于 2 型糖尿病（T2DM）、阻塞性睡眠呼吸暂停和并发症的患者水平数据。主要结局是体重指数（BMI）多余部分丢失的百分比（%EBMIL）。两项试验中的次要预设结局均包括总减重、合并症缓解、生活质量（QoL）改善和整体发病率。

结果

LSG 术前共进行了 228 例，LRYGB 术前共进行了 229 例。LSG 术后 5 年随访 199 例（87.3%），LRYGB 术后 199 例（87.1%）。基于模型的平均估计值显示，LRYGB 术后的 %EBMIL 比 LSG 术后高 7.0（95%置信区间 3.5 至 10.5）个百分点（分别为 62.7%和 55.5%；P<0.001）。两种术式在 T2DM 缓解、阻塞性睡眠呼吸暂停或 QoL 改善方面无差异；与 LSG 相比，LRYGB 术后高血压缓解更好（60.3%比 44.9%；P=0.049）。LRYGB 的并发症发生率高于 LSG（37.2%比 22.5%；P=0.001），但综合并发症指数（CCI）值的平均值无差异（30.6 比 31.0 分；P=0.859）。