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结直肠吻合手术中吻合器与手工缝合方法的比较

Stapled versus handsewn methods for colorectal anastomosis surgery.

作者信息

Neutzling Cristiane B, Lustosa Suzana A S, Proenca Igor M, da Silva Edina M K, Matos Delcio

机构信息

Interdisciplinary Surgical Science Program,UNIFESP-Escola Paulista deMedicina, São Paulo, Brazil.

出版信息

Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003144. doi: 10.1002/14651858.CD003144.pub2.

Abstract

BACKGROUND

Previous systematic reviews comparing stapled and handsewn colorectal anastomosis that are available in the medical literature have not shown either technique to be superior. An update of this systematic review was performed to find out if there are any data that properly answer this question.

OBJECTIVES

To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis surgery. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications.

SEARCH METHODS

A computerized search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE according to the strategies of the Colorectal Cancer Group of The Cochrane Collaboration. There were no limits upon language, date or other criteria. A revised search strategy was performed for this updated version of the review May 2011.

SELECTION CRITERIA

All randomised controlled trials (RCTs) in which stapled and handsewn colorectal anastomosis techniques were compared. Participants were adult patients undergoing elective colorectal anastomosis surgery. The interventions were endoluminal circular stapler and handsewn colorectal anastomosis surgery. Outcomes considered were a) mortality; b) overall anastomotic dehiscence; c) clinical anastomotic dehiscence; d) radiological anastomotic dehiscence; e) stricture; f) anastomotic haemorrhage; g) reoperation; h) wound infection; i) anastomosis duration; and j) hospital stay.

DATA COLLECTION AND ANALYSIS

Data were independently analysed by the two review authors (CBN, SASL) and cross-checked. The methodological quality of each trial was assessed by the same two authors. After searching the literature for this update, no study was added to those in the previous version of this review. Details of randomizations (generation and concealment), blinding, whether an intention-to-treat analysis was done or not, and the number of patients lost to follow-up were recorded. The analysis of the risk of bias was updated according to the software Review Manager 5.1. The results of each RCT were summarized on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by the characteristics of the participants, interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The risk difference (RD) method (random-effects model) and number needed to treat (NNT) for dichotomous outcome measures and weighted mean differences (WMD) for continuous outcomes measures, with the corresponding 95% confidence intervals (CI), were presented in this review. Statistical heterogeneity was evaluated using a funnel plot and the Chi(2) test.

MAIN RESULTS

Of the 1233 patients enrolled in nine identified trials, 622 were treated with staples and 611 with manual suture. The following main results were obtained. a) Mortality, result based on 901 patients: RD -0.6%, 95% CI -2.8% to +1.6%. b) Overall dehiscence, result based on 1233 patients: RD 0.2%, 95% CI -5.0% to +5.3%. c) Clinical anastomotic dehiscence, result based on 1233 patients: RD -1.4%, 95% CI -5.2 to +2.3%. d) Radiological anastomotic dehiscence, result based on 825 patients: RD 1.2%, 95% CI -4.8% to +7.3%. e) Stricture, result based on 1042 patients: RD 4.6%, 95% CI 1.2% to 8.1%; NNT 17, 95% CI 12 to 31. f) Anastomotic haemorrhage, result based on 662 patients: RD 2.7%, 95% CI -0.1% to +5.5%. g) Reoperation, result based on 544 patients: RD 3.9%, 95% CI 0.3% to 7.4%. h) Wound infection, result based on 567 patients: RD 1.0%, 95% CI -2.2% to +4.3%. i) Anastomosis duration, result based on one study (159 patients): WMD -7.6 minutes, 95% CI -12.9 to -2.2 minutes. j) Hospital stay, result based on one study (159 patients): WMD 2.0 days, 95% CI -3.27 to +7.2 days.

AUTHORS' CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis surgery, regardless of the level of anastomosis. There were no randomised clinical trials comparing these two types of anastomosis in elective conditions in the last decade. The relevance of this research question has possibly lost its strength where elective surgery is concerned. However, in risk situations, such as emergency surgery, trauma and inflammatory bowel disease, new clinical trials are needed.

摘要

背景

医学文献中先前比较吻合器与手工缝合结直肠吻合术的系统评价未显示出哪种技术更具优势。进行此次系统评价更新以查明是否有能恰当回答该问题的数据。

目的

比较吻合器与手工缝合结直肠吻合术的安全性和有效性。检验了以下主要假设:吻合器技术更有效,因为它能降低并发症发生率。

检索方法

根据Cochrane协作网结直肠癌组的策略,在Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE中进行计算机检索。对语言、日期或其他标准没有限制。针对2011年5月此次更新版本的评价执行了修订的检索策略。

选择标准

所有比较吻合器与手工缝合结直肠吻合术技术的随机对照试验(RCT)。参与者为接受择期结直肠吻合术的成年患者。干预措施为腔内圆形吻合器和手工缝合结直肠吻合术。考虑的结局包括:a)死亡率;b)总体吻合口裂开;c)临床吻合口裂开;d)影像学吻合口裂开;e)狭窄;f)吻合口出血;g)再次手术;h)伤口感染;i)吻合时间;j)住院时间。

数据收集与分析

两位评价作者(CBN、SASL)独立分析数据并交叉核对。每项试验的方法学质量由这两位作者评估。在检索此次更新的文献后,未在此次评价的先前版本中的研究基础上增加新研究。记录随机化细节(产生和隐藏)、盲法、是否进行意向性分析以及失访患者数量。根据Review Manager 5.1软件更新偏倚风险分析。每项RCT的结果在2×2表格中按意向性分析的基础上针对每个结局进行总结。外部效度由参与者、干预措施和结局的特征定义。RCT根据结直肠吻合水平分层。本评价呈现了二分类结局指标的风险差异(RD)方法(随机效应模型)和需治疗人数(NNT)以及连续性结局指标的加权均数差异(WMD),并给出相应的95%置信区间(CI)。使用漏斗图和卡方检验评估统计异质性。

主要结果

在纳入9项已识别试验的1233例患者中,622例接受吻合器治疗,611例接受手工缝合治疗。获得了以下主要结果。a)死亡率,基于901例患者的结果:RD -0.6%,95%CI -2.8%至 +1.6%。b)总体裂开,基于1233例患者的结果:RD 0.2%,95%CI -5.0%至 +5.3%。c)临床吻合口裂开,基于1233例患者的结果:RD -1.4%,95%CI -5.2%至 +2.3%。d)影像学吻合口裂开,基于825例患者的结果:RD 1.2%,95%CI -4.8%至 +7.3%。e)狭窄,基于1042例患者的结果:RD 4.6%,95%CI 1.2%至8.1%;NNT 17,95%CI 12至31。f)吻合口出血,基于662例患者的结果:RD 2.7%,95%CI -0.1%至 +5.5%。g)再次手术,基于544例患者的结果:RD 3.9%,95%CI 0.3%至7.4%。h)伤口感染,基于567例患者的结果:RD 1.0%,95%CI -2.2%至 +4.3%。i)吻合时间,基于一项研究(159例患者)的结果:WMD -7.6分钟,95%CI -12.9至 -2.2分钟。j)住院时间,基于一项研究(159例患者)的结果:WMD 2.0天,95%CI -3.27至 +7.2天。

作者结论

所发现的证据不足以证明在结直肠吻合术手术中,吻合器技术相对于手工缝合技术有任何优势,无论吻合水平如何。在过去十年中,没有在择期情况下比较这两种吻合术的随机临床试验。就择期手术而言,这个研究问题的相关性可能已失去其重要性。然而,在诸如急诊手术、创伤和炎症性肠病等风险情况下,需要新的临床试验。

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