Mannu Gurdeep S, Sudul Maria K, Bettencourt-Silva Joao H, Cumber Elspeth, Li Fangfang, Clark Allan B, Loke Yoon K
Nuffield Department of Population Health, University of Oxford, CTSU, Richard Doll Building, Old Road Campus, Roosevelt Drive, Headington, Oxford, Oxfordshire, UK, OX3 7LF.
Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
Laparoscopic appendectomy is amongst the most common general surgical procedures performed in the developed world. Arguably, the most critical part of this procedure is effective closure of the appendix stump to prevent catastrophic intra-abdominal complications from a faecal leak into the abdominal cavity. A variety of methods to close the appendix stump are used worldwide; these can be broadly divided into traditional ligatures (such as intracorporeal or extracorporeal ligatures or Roeder loops) and mechanical devices (such as stapling devices, clips, or electrothermal devices). However, the optimal method remains unclear.
To compare all surgical techniques now used for appendix stump closure during laparoscopic appendectomy.
In June 2017, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 6) in the Cochrane Library, MEDLINE Ovid (1946 to 14 June 2017), Embase Ovid (1974 to 14 June 2017), Science Citation Index - Expanded (14 June 2017), China Biological Medicine Database (CBM), the World Health Organization International Trials Registry Platform search portal, ClinicalTrials.gov, Current Controlled Trials, the Chinese Clinical Trials Register, and the EU Clinical Trials Register (all in June 2017). We searched the reference lists of relevant publications as well as meeting abstracts and Conference Proceedings Citation Index to look for additional relevant clinical trials.
We included all randomised controlled trials (RCTs) that compared mechanical appendix stump closure (stapler, clips, or electrothermal devices) versus ligation (Endoloop, Roeder loop, or intracorporeal knot techniques) for uncomplicated appendicitis.
Two review authors identified trials for inclusion, collected data, and assessed risk of bias independently. We performed the meta-analysis using Review Manager 5. We calculated the odds ratio (OR) for dichotomous outcomes and the mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs).
We included eight randomised studies encompassing 850 participants. Five studies compared titanium clips versus ligature, two studies compared an endoscopic stapler device versus ligature, and one study compared an endoscopic stapler device, titanium clips, and ligature. In our analyses of primary outcomes, we found no differences in total complications (OR 0.97, 95% CI 0.27 to 3.50, 8 RCTs, very low-quality evidence), intraoperative complications (OR 0.93, 95% CI 0.34 to 2.55, 8 RCTs, very low-quality evidence), or postoperative complications (OR 0.80, 95% CI 0.21 to 3.13, 8 RCTs, very low-quality evidence) between ligature and all types of mechanical devices. However, our analyses of secondary outcomes revealed that use of mechanical devices saved approximately nine minutes of total operating time when compared with use of a ligature (mean difference (MD) -9.04 minutes, 95% CI -12.97 to -5.11 minutes, 8 RCTs, very low-quality evidence). However, this finding did not translate into a clinically or statistically significant reduction in inpatient hospital stay (MD 0.02 days, 95% CI -0.12 to 0.17 days, 8 RCTs, very low-quality evidence). Available information was insufficient for reliable comparison of total hospital costs and postoperative pain/quality of life between the two approaches. Overall, evidence across all analyses was of very low quality, with substantial potential for confounding factors. Given the limitations of all studies in terms of bias and the low quality of available evidence, a clear conclusion regarding superiority of any one particular type of mechanical device over another is not possible.
AUTHORS' CONCLUSIONS: Evidence is insufficient at present to advocate omission of conventional ligature-based appendix stump closure in favour of any single type of mechanical device over another in uncomplicated appendicitis.
腹腔镜阑尾切除术是发达国家最常见的普通外科手术之一。可以说,该手术最关键的部分是有效闭合阑尾残端,以防止粪便漏入腹腔引发灾难性的腹腔内并发症。全球使用了多种闭合阑尾残端的方法;这些方法大致可分为传统结扎法(如体内或体外结扎或罗德环)和机械装置(如吻合器、夹子或电热装置)。然而,最佳方法仍不明确。
比较目前在腹腔镜阑尾切除术中用于闭合阑尾残端的所有手术技术。
2017年6月,我们检索了Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL;2017年第6期)、MEDLINE Ovid(1946年至2017年6月14日)、Embase Ovid(1974年至2017年6月14日)、科学引文索引扩展版(2017年6月14日)、中国生物医学数据库(CBM)、世界卫生组织国际临床试验注册平台搜索门户、ClinicalTrials.gov、当前对照试验、中国临床试验注册库和欧盟临床试验注册库(均为2017年6月)。我们检索了相关出版物的参考文献列表以及会议摘要和会议论文引文索引,以寻找其他相关临床试验。
我们纳入了所有比较机械性阑尾残端闭合(吻合器、夹子或电热装置)与结扎(Endoloop、罗德环或体内打结技术)用于单纯性阑尾炎的随机对照试验(RCT)。
两位综述作者独立识别纳入试验、收集数据并评估偏倚风险。我们使用Review Manager 5进行荟萃分析。我们计算了二分结局的比值比(OR)和连续结局的平均差(MD),并给出95%置信区间(CI)。
我们纳入了八项随机研究,共850名参与者。五项研究比较了钛夹与结扎,两项研究比较了内镜吻合器装置与结扎,一项研究比较了内镜吻合器装置、钛夹和结扎。在我们对主要结局的分析中,我们发现结扎与所有类型的机械装置在总并发症(OR 0.97,95%CI 0.27至3.50,8项RCT,极低质量证据)、术中并发症(OR 0.93,95%CI 0.34至2.55,8项RCT,极低质量证据)或术后并发症(OR 0.80,95%CI 0.21至3.13,8项RCT,极低质量证据)方面没有差异。然而,我们对次要结局的分析显示,与使用结扎相比,使用机械装置可节省约9分钟的总手术时间(平均差(MD)-9.04分钟,95%CI -12.97至-5.11分钟,8项RCT,极低质量证据)。然而,这一发现并未转化为住院时间在临床或统计学上的显著缩短(MD 0.02天,95%CI -0.12至0.17天,8项RCT,极低质量证据)。现有信息不足以可靠比较两种方法的总住院费用和术后疼痛/生活质量。总体而言,所有分析中的证据质量都非常低,存在大量混杂因素的可能性。鉴于所有研究在偏倚方面的局限性以及现有证据的低质量,无法明确得出任何一种特定类型的机械装置优于另一种的结论。
目前证据不足,无法主张在单纯性阑尾炎中放弃基于传统结扎的阑尾残端闭合方法而倾向于任何一种单一类型的机械装置。