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腹腔镜胆囊切除术的微型端口与标准端口对比

Miniports versus standard ports for laparoscopic cholecystectomy.

作者信息

Gurusamy Kurinchi Selvan, Vaughan Jessica, Ramamoorthy Rajarajan, Fusai Giuseppe, Davidson Brian R

机构信息

Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, UK, NW3 2PF.

出版信息

Cochrane Database Syst Rev. 2013 Aug 1;2013(8):CD006804. doi: 10.1002/14651858.CD006804.pub3.

Abstract

BACKGROUND

In conventional (standard) port laparoscopic cholecystectomy, four abdominal ports (two of 10 mm diameter and two of 5 mm diameter) are used. Recently, use of smaller ports, miniports, have been reported.

OBJECTIVES

To assess the benefits and harms of miniport (defined as ports smaller than the standard ports) laparoscopic cholecystectomy versus standard port laparoscopic cholecystectomy.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until February 2013 to identify randomised clinical trials of relevance to this review.

SELECTION CRITERIA

Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing miniport versus standard port laparoscopic cholecystectomy were considered for the review.

DATA COLLECTION AND ANALYSIS

Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using RevMan analysis. For each outcome we calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI).

MAIN RESULTS

We included 12 trials with 734 patients randomised to miniport laparoscopic cholecystectomy (380 patients) versus standard laparoscopic cholecystectomy (351 patients). Only one trial which included 70 patients was of low risk of bias. Miniport laparoscopic cholecystectomy could be completed successfully in more than 80% of patients in most trials. The remaining patients were mostly converted to standard port laparoscopic cholecystectomy but some were also converted to open cholecystectomy. These patients were included for the outcome conversion to open cholecystectomy but excluded from other outcomes. Accordingly, the results of the other outcomes are on 343 patients in the miniport laparoscopic cholecystectomy group and 351 patients in the standard port laparoscopic cholecystectomy group, and therefore the results have to be interpreted with extreme caution.There was no mortality in the seven trials that reported mortality (0/194 patients in miniport laparoscopic cholecystectomy versus 0/203 patients in standard port laparoscopic cholecystectomy). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the proportion of patients who developed serious adverse events (eight trials; 460 patients; RR 0.33; 95% CI 0.04 to 3.08) (miniport laparoscopic cholecystectomy: 1/226 (adjusted proportion 0.4%) versus standard laparoscopic cholecystectomy: 3/234 (1.3%); quality of life at 10 days after surgery (one trial; 70 patients; SMD -0.20; 95% CI -0.68 to 0.27); or in whom the laparoscopic operation had to be converted to open cholecystectomy (11 trials; 670 patients; RR 1.23; 95% CI 0.44 to 3.45) (miniport laparoscopic cholecystectomy: 8/351 (adjusted proportion 2.3%) versus standard laparoscopic cholecystectomy 6/319 (1.9%)). Miniport laparoscopic cholecystectomy took five minutes longer to complete than standard laparoscopic cholecystectomy (12 trials; 695 patients; MD 4.91 minutes; 95% CI 2.38 to 7.44). There were no significant differences between miniport laparoscopic cholecystectomy and standard laparoscopic cholecystectomy in the length of hospital stay (six trials; 351 patients; MD -0.00 days; 95% CI -0.12 to 0.11); the time taken to return to activity (one trial; 52 patients; MD 0.00 days; 95% CI -0.31 to 0.31); or in the time taken for the patient to return to work (two trials; 187 patients; MD 0.28 days; 95% CI -0.44 to 0.99) between the groups. There was no significant difference in the cosmesis scores at six months to 12 months after surgery between the two groups (two trials; 152 patients; SMD 0.13; 95% CI -0.19 to 0.46).

AUTHORS' CONCLUSIONS: Miniport laparoscopic cholecystectomy can be completed successfully in more than 80% of patients. There appears to be no advantage of miniport laparoscopic cholecystectomy in terms of decreasing mortality, morbidity, hospital stay, return to activity, return to work, or improving cosmesis. On the other hand, there is a modest increase in operating time after miniport laparoscopic cholecystectomy compared with standard port laparoscopic cholecystectomy and the safety of miniport laparoscopic cholecystectomy is yet to be established. Miniport laparoscopic cholecystectomy cannot be recommended routinely outside well-designed randomised clinical trials. Further trials of low risks of bias and low risks of random errors are necessary.

摘要

背景

在传统(标准)端口腹腔镜胆囊切除术中,需使用四个腹部端口(两个直径10毫米和两个直径5毫米)。最近,有报道称使用了更小的端口,即微型端口。

目的

评估微型端口(定义为小于标准端口的端口)腹腔镜胆囊切除术与标准端口腹腔镜胆囊切除术的利弊。

检索方法

我们检索了Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版,直至2013年2月,以识别与本综述相关的随机临床试验。

选择标准

本综述仅考虑比较微型端口与标准端口腹腔镜胆囊切除术的随机临床试验(无论语言、盲法或发表状态如何)。

数据收集与分析

两位综述作者独立收集数据。我们使用RevMan分析,采用固定效应和随机效应模型对数据进行分析。对于每个结局,我们计算了风险比(RR)、平均差(MD)或标准化平均差(SMD)以及95%置信区间(CI)。

主要结果

我们纳入了12项试验,734例患者被随机分配至微型端口腹腔镜胆囊切除术组(380例患者)和标准腹腔镜胆囊切除术组(351例患者)。只有一项纳入70例患者的试验偏倚风险较低。在大多数试验中,超过80%的患者能够成功完成微型端口腹腔镜胆囊切除术。其余患者大多转为标准端口腹腔镜胆囊切除术,但也有一些转为开腹胆囊切除术。这些患者被纳入转为开腹胆囊切除术的结局分析,但被排除在其他结局分析之外。因此,微型端口腹腔镜胆囊切除术组343例患者和标准端口腹腔镜胆囊切除术组351例患者的其他结局结果必须极其谨慎地解读。在报告了死亡率的7项试验中无死亡病例(微型端口腹腔镜胆囊切除术组0/194例患者,标准端口腹腔镜胆囊切除术组0/203例患者)。微型端口腹腔镜胆囊切除术与标准腹腔镜胆囊切除术在发生严重不良事件的患者比例方面无显著差异(8项试验;460例患者;RR 0.33;95%CI 0.04至3.08)(微型端口腹腔镜胆囊切除术组:1/226例(校正比例0.4%),标准腹腔镜胆囊切除术组:3/234例(1.3%));术后10天的生活质量(1项试验;70例患者;SMD -0.20;95%CI -0.68至0.27);或腹腔镜手术必须转为开腹胆囊切除术的患者比例(11项试验;670例患者;RR 1.23;95%CI 0.44至3.45)(微型端口腹腔镜胆囊切除术组:8/351例(校正比例2.3%),标准腹腔镜胆囊切除术组6/319例(1.9%))。微型端口腹腔镜胆囊切除术比标准腹腔镜胆囊切除术多花5分钟完成(12项试验;695例患者;MD 4.91分钟;9%CI 2.38至7.44)。微型端口腹腔镜胆囊切除术与标准腹腔镜胆囊切除术在住院时间(6项试验;351例患者;MD -0.00天;95%CI -0.12至0.11)、恢复活动时间(1项试验;52例患者;MD 0.00天;95%CI -0.31至0.31)或患者恢复工作时间(2项试验;187例患者;MD 0.28天;95%CI -0.44至0.99)方面无显著差异。两组术后6个月至12个月的美容评分无显著差异(2项试验;152例患者;SMD 0.13;95%CI -0.19至0.46)。

作者结论

超过80%的患者能够成功完成微型端口腹腔镜胆囊切除术。微型端口腹腔镜胆囊切除术在降低死亡率、发病率、住院时间、恢复活动、恢复工作或改善美容方面似乎没有优势。另一方面,与标准端口腹腔镜胆囊切除术相比,微型端口腹腔镜胆囊切除术后手术时间略有增加,且微型端口腹腔镜胆囊切除术的安全性尚未确立。在精心设计的随机临床试验之外,不建议常规进行微型端口腹腔镜胆囊切除术。有必要进行偏倚风险低和随机误差风险低的进一步试验。

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