Murakami Katsuhiro, Hoshino Nobuaki, Hida Koya, Obama Kazutaka, Sakai Yoshiharu, Watanabe Norio
Department of Surgery, Kyoto University Hospital, Kyoto, Japan.
Department of Psychiatry, Soseikai General Hospital, Kyoto, Japan.
Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014612. doi: 10.1002/14651858.CD014612.pub2.
Internal hernia is one of the most severe complications observed in people undergoing Roux-en-Y gastric bypass (RYGB). There are some who advocate for the closure of defects to prevent internal hernias. However, the closure of these defects might be associated with an increased risk of small bowel obstruction, resulting from a kink in the anastomosis of the small intestines. Currently, there is a lack of robust evidence demonstrating the benefits of defect closure.
To assess the benefits and harms of defect closure for prevention of internal hernia after Roux-en Y gastric bypass in bariatric surgery.
We searched CENTRAL, MEDLINE, and Embase to August 2024. We reviewed the reference lists of included studies and reached out to the study authors to obtain any missing data. We also searched PubMed, grey literature in the OpenGrey database, Clinical Trials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).
We included randomised controlled trials (RCTs) that included people with obesity (defined as a body-mass index (BMI) ≥ 35 kg/m²) who underwent laparoscopic or robotic RYGB in bariatric surgery, and compared the closure of defects with the non-closure of defects. We excluded quasi-randomised trials, cluster-RCTs, and cross-over trials.
The critical outcomes assessed were the incidence of internal hernia with bowel obstruction within 10 years, the incidence of postoperative overall complications within 30 days, and the incidence of postoperative mortality within 30 days. The important outcomes included the incidence of intraoperative overall complications, length of hospital stay, and the postoperative pain resulting from gastric bypass surgery, assessed using a visual analogue scale (VAS) two years after surgery.
Two review authors independently evaluated the risk of bias for each included study using the Cochrane RoB 2 tool.
Two review authors independently assessed the methodological quality and extracted data from the included trials. We performed a random-effects meta-analysis for data synthesis. We calculated risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes, and mean difference (MD) with 95% CIs for continuous outcomes. We assessed the certainty of evidence based on the GRADE approach.
We identified three RCTs with 3010 participants, which met our inclusion criteria. The closure of mesenteric defects used non-absorbable, interrupt closure in one study, and non-absorbable running sutures in two studies.
The closure of defects during RYGB may reduce the incidence of internal hernia with bowel obstruction within 10 years compared with non-closure (RR 0.32, 95% CI 0.24 to 0.42; P < 0.00001, I² = 0 %; 3 studies, 3010 participants; low-certainty evidence). The closure of defects may result in little to no difference in the incidence of postoperative overall complications within 30 days compared to non-closure (RR 1.13, 95% CI 0.87 to 1.47; P = 0.35, I² = 0 %; 2 studies, 2609 participants; low-certainty evidence). The closure of defects may result in little to no difference in the incidence of postoperative mortality within 30 days compared to non-closure (RR 2.97, 95% CI 0.12 to 72.93; P = 0.50, I² not applicable; 2 studies, 2908 participants; very low-certainty evidence). The closure of defects may result in little to no difference in the incidence of intraoperative overall complications compared to non-closure (RR 0.87, 95% CI 0.54 to 1.42; P = 0.59, I² not applicable; 1 study, 2507 participants; very low-certainty evidence). Closure defects may lead to the longer length of hospital stay; however, the evidence is very uncertain (MD 0.27 days, 95% CI 0.15 to 0.38; P < 0.00001; I² = 93%; 2 studies, 2609 participants; very low-certainty evidence). Postoperative pain from gastric bypass surgery was not assessed because there was not enough information available for analysis.
AUTHORS' CONCLUSIONS: The closure of defects may be more effective than the non-closure of defects for prevention of internal hernia after RYGB. However, the small number of trials limited our confidence in the evidence. There is little to no difference between the closure and non-closure of defects in the incidence of postoperative overall complications, the incidence of postoperative mortality, and the incidence of intraoperative overall complications. The length of hospital stay may be longer for those undergoing defect closure than for those who did not have the defects closed. The evidence is very uncertain about the incidence of postoperative mortality, the incidence of intraoperative overall complications, and the length of hospital stay. Additional evidence based on trials designed to be at low risk of bias and with an adequate sample size is imperative.
This Cochrane review had no dedicated funding.
The protocol was registered in the Cochrane Library on 9 May 2023.
内疝是接受Roux-en-Y胃旁路术（RYGB）的患者中观察到的最严重并发症之一。有些人主张封闭缺损以预防内疝。然而，这些缺损的封闭可能会增加小肠梗阻的风险，这是由小肠吻合处的扭结引起的。目前，缺乏有力证据证明封闭缺损的益处。
评估在减重手术中，封闭缺损预防RYGB术后内疝的利弊。
我们检索了截至2024年8月的Cochrane系统评价、MEDLINE和Embase。我们查阅了纳入研究的参考文献列表，并联系研究作者以获取任何缺失的数据。我们还检索了PubMed、OpenGrey数据库中的灰色文献、ClinicalTrials.gov和世界卫生组织（WHO）国际临床试验注册平台（ICTRP）。
我们纳入了随机对照试验（RCT），这些试验纳入了肥胖患者（定义为体重指数（BMI）≥35kg/m²），他们在减重手术中接受了腹腔镜或机器人RYGB，并比较了缺损封闭与未封闭的情况。我们排除了半随机试验、整群RCT和交叉试验。
评估的关键结局是10年内伴有肠梗阻的内疝发生率、30天内术后总体并发症发生率和30天内术后死亡率。重要结局包括术中总体并发症发生率、住院时间以及术后两年使用视觉模拟量表（VAS）评估的胃旁路手术引起的术后疼痛。
两位综述作者使用Cochrane偏倚风险2工具独立评估每个纳入研究的偏倚风险。
两位综述作者独立评估方法学质量并从纳入试验中提取数据。我们进行随机效应荟萃分析以进行数据合成。对于二分结局，我们计算了风险比（RR）及其95%置信区间（CI），对于连续结局，我们计算了均差（MD）及其95%CI。我们基于GRADE方法评估证据的确定性。
我们确定了三项RCT，共3010名参与者，符合我们的纳入标准。在一项研究中，肠系膜缺损的封闭使用不可吸收的间断缝合，在两项研究中使用不可吸收的连续缝合。
与不封闭相比，RYGB期间封闭缺损可能会降低10年内伴有肠梗阻的内疝发生率（RR 0.32，95%CI 0.24至0.42；P<0.00001，I²=0%；3项研究，3010名参与者；低确定性证据）。与不封闭相比，封闭缺损在30天内术后总体并发症发生率上可能几乎没有差异（RR 1.13，95%CI 0.87至1.47；P=0.35，I²=0%；2项研究，2609名参与者；低确定性证据）。与不封闭相比，封闭缺损在30天内术后死亡率上可能几乎没有差异（RR 2.97，95%CI 0.12至72.93；P=0.50，I²不适用；2项研究，2908名参与者；极低确定性证据）。与不封闭相比，封闭缺损在术中总体并发症发生率上可能几乎没有差异（RR 0.87，95%CI 0.54至1.42；P=0.59，I²不适用；1项研究，2507名参与者；极低确定性证据）。封闭缺损可能导致住院时间延长；然而，证据非常不确定（MD 0.27天，95%CI 0.15至0.38；P<0.00001；I²=93%；2项研究，2609名参与者；极低确定性证据）。由于没有足够的信息进行分析，因此未评估胃旁路手术的术后疼痛。
对于预防RYGB术后的内疝，封闭缺损可能比不封闭更有效。然而，试验数量较少限制了我们对证据的信心。在术后总体并发症发生率、术后死亡率和术中总体并发症发生率方面，封闭与不封闭缺损之间几乎没有差异。接受缺损封闭的患者住院时间可能比未封闭缺损的患者更长。关于术后死亡率、术中总体并发症发生率和住院时间的证据非常不确定。基于设计为低偏倚风险且样本量充足的试验的更多证据势在必行。
本Cochrane综述没有专门的资金。
该方案于2023年5月9日在Cochrane图书馆注册。
