Department of Surgery, Zealand University Hospital, Koege, Denmark.
Department of Surgery, Hospital South West Jutland, University Hospital Southern Denmark, Esbjerg, Denmark.
Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
Internal herniation is a well known and potentially life-threatening complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The aim of this study was to evaluate the benefit and harm of closing the mesenteric defects with clips during LRYGB to prevent internal herniation.
This was a single-centre, single-blinded RCT. Patients eligible for LRYGB were randomized to surgery with or without closure of mesenteric defects with clips. The primary endpoint was the incidence of (intermittent) internal herniation after LRYGB with a minimum follow-up of 24 months. Secondary outcomes were duration of surgery, number of clips used, trocars and sutures used, postoperative pain measured by a visual analogue scale (VAS), and postoperative complications.
Between 13 August 2012 and 18 May 2017, 401 patients were randomized to closure (201) or non-closure (200) of mesenteric defects. Median follow-up for both groups was 59 months (range 8-67 and 16-67 months in non-closure and closure groups respectively). The cumulated risk of internal herniation after 2 years was 8.0 per cent in the non-closure group compared with 4.5 per cent in the closure group (hazard ratio (HR) 1.81, 95 per cent c.i. 0.80 to 4.12; P = 0.231). At 5 years, rates were 15.5 and 6.5 per cent respectively (HR 2.52, 1.32 to 4.81; P = 0.005). Closure of mesenteric defects increased operating time by a median of 4 min (95 per cent c.i. 52 to 56 min for the non-closure group and 56 to 60 min for the closure group; P = 0.002). There was no difference in postoperative blood transfusion rates and VAS scores between the groups.
Routine closure of the mesenteric defects in LRYGB with clips is associated with a lower rate of internal herniation. Registration number: NCT01595230 (http://www.clinicaltrials.gov).
腹腔镜 Roux-en-Y 胃旁路术（LRYGB）后发生内疝是一种众所周知且可能危及生命的并发症。本研究旨在评估 LRYGB 中使用夹子关闭肠系膜缺损以预防内疝的益处和危害。
这是一项单中心、单盲 RCT。有资格进行 LRYGB 的患者被随机分为手术夹闭组和非夹闭组。主要终点是 LRYGB 后（间歇性）内疝的发生率，最低随访时间为 24 个月。次要结局为手术时间、使用夹数量、套管和缝线数量、术后疼痛（视觉模拟评分）和术后并发症。
2012 年 8 月 13 日至 2017 年 5 月 18 日，401 名患者被随机分为夹闭（201 名）或不夹闭（200 名）肠系膜缺损。两组的中位随访时间分别为 59 个月（非夹闭组 8-67 个月，夹闭组 16-67 个月）。非夹闭组 2 年后内疝累积风险为 8.0%，夹闭组为 4.5%（风险比（HR）1.81，95%置信区间（CI）0.80 至 4.12；P=0.231）。5 年时，发生率分别为 15.5%和 6.5%（HR 2.52，1.32 至 4.81；P=0.005）。夹闭肠系膜缺损使手术时间中位数增加了 4 分钟（非夹闭组 95%CI 为 52-56 分钟，夹闭组为 56-60 分钟；P=0.002）。两组间术后输血率和 VAS 评分无差异。
LRYGB 中使用夹子常规夹闭肠系膜缺损可降低内疝发生率。注册号：NCT01595230（http://www.clinicaltrials.gov）。
