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Intervention Review

Primary closure versus T-tube drainage after open common bile duct exploration

  1. Kurinchi Selvan Gurusamy1,*,
  2. Kumarakrishnan Samraj2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 24 JAN 2007

Assessed as up-to-date: 7 NOV 2006

DOI: 10.1002/14651858.CD005640.pub2


How to Cite

Gurusamy KS, Samraj K. Primary closure versus T-tube drainage after open common bile duct exploration. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005640. DOI: 10.1002/14651858.CD005640.pub2.

Author Information

  1. 1

    Royal Free Hospital and University College School of Medicine, University Department of Surgery, London, UK

  2. 2

    John Radcliffe Hospital, Department of General Surgery, Oxford, UK

*Kurinchi Selvan Gurusamy, University Department of Surgery, Royal Free Hospital and University College School of Medicine, 9th Floor, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. kurinchi2k@hotmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 24 JAN 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Between 5% and 11% of people undergoing cholecystectomy have common bile duct stones. Open common bile duct exploration is an important operation when endoscopic retrograde cholangio-pancreatography fails or when expertise for laparoscopic common bile duct exploration is not available. The optimal method for performing open common bile duct exploration is unclear.

Objectives

The aim is to assess the benefits and harms of primary closure versus routine T-tube drainage in open common bile duct exploration for common bile duct stones.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until January 2006.

Selection criteria

We considered for inclusion all randomised clinical trials comparing primary closure (with or without biliary stent) versus T-tube drainage after open common bile duct exploration.

Data collection and analysis

We collected the data on the characteristics, methodological quality, mortality, morbidity, operating time, and hospital stay from each trial. We analysed the data with both the fixed-effect and the random-effects model using RevMan Analysis. For each outcome we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis.

Main results

We included five trials with 324 patients randomised: 165 to primary closure without stent and 159 to T-tube. Three of the five trials were considered to have adequate methodological quality, but all lacked blinded outcome assessment. The primary closure group had significantly lower positive bile culture (3 trials, OR 0.22, 95% CI 0.10 to 0.45) and wound infection (5 trials, OR 0.29, 95% CI 0.15 to 0.56). When only trials with high methodological quality were included, there was no statistically significant difference in any of the outcomes except positive bile culture, which became non-significant when the random-effects model was used. The deaths of the three patients in the T-tube group were directly related to surgery and sepsis. Bile peritonitis was higher in the T-tube group (2.9%) than in the primary closure group (1%) (not statistically significant). Hospital stay was significantly longer in the T-tube group compared with the primary closure group in three of the four trials, which reported on the hospital stay. The only trial comparing primary closure with stent (37 patients) versus T-tube drainage (44 patients) did not reveal any statistically significant difference in any of the reported outcomes (mortality, re-operations, wound infection, and hospital stay). There was one case of stent migration, which could not be retrieved after two attempts of ERCP.

Authors' conclusions

Primary closure after common bile duct exploration seems at least as safe as T-tube drainage. We need randomised trials that assess whether stents may offer benefits.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Primary closure of common bile duct after open exploration seems safe

Open common bile duct exploration is an important surgical intervention when endoscopic retrograde cholangio-pancreatography fails and the expertise for laparoscopic common bile duct exploration is not available. The main reasons for using T-tube drainage after open common bile duct exploration are post-operative drainage of the bile duct and visualisation and extraction of retained bile duct stones. This systematic review of five randomised trials with 324 participants shows that primary closure of common bile duct seems at least as safe as T-tube closure and may decrease bile infection, infective complications, and hospital stay.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

開腹總膽管探查術之後實施初步縫合對照T TUBE引流術的比較

接受膽囊切除術時約有5% −11%的人會有總膽管膽石。當內視鏡逆行胰膽管造影術失敗或缺乏腹腔鏡總膽管探查術的專家時,開腹總膽管探查術是一項重要的手術。 但目前還不清楚實施開腹總膽管探查術的最佳方法。

目標

目的在於對總膽管結石進行開腹膽總管探查術之後實施初步縫合對照常規T TUBE引流術的利弊。

搜尋策略

我們搜尋截至2006年1月的The Cochrane HepatoBiliary Group Controlled Trials Register,Cochrane Library 中的Cochrane Central Register of Controlled Trials、 MEDLINE、EMBASE和Science Citation Index Expanded。

選擇標準

我們收錄所有比較開腹總膽管探查術之後實施初步縫合(含有或不含有 膽道支架)對照T TUBE引流術的隨機臨床試驗。

資料收集與分析

我們從每個試驗收集有關試驗特性、研究方法品質、死亡率、發病率、手術時間和住院日等資料。我們使用RevMan分析軟體以固定效果和隨機效果模式分析資料。對於每個結果(outcome),我們以治療意向,計算odds ratio(OR)及其95%信賴區間 (CI)。

主要結論

我們共收納5個試驗,共324 位病人: 其中165 人分配至無支架的初步縫合組,159 分配至T TUBE引流術組。5個試驗中有3個試驗被認為有適當的研究方法品質,但是所有試驗皆缺乏結果評估遮盲。初步縫合組的膽汁培養陽性率(3個試驗, OR 0.22, 95% CI 0.10 0.45)和傷口感染率(5個試驗, OR 0.29, 95% CI 0.15 0.56) 明顯較低。當只包括研究方法品質較高的試驗時,除了膽汁培養陽性率以外,所有結果皆沒有顯示統計上顯著差異。而當使用隨機效果模式時,膽汁培養陽性率也變成不具顯著性。 T TUBE引流術組的3位病人死亡直接和手術及敗血症相關。T TUBE引流術組(2.9%)的膽汁性腹膜炎比例大於初步縫合組(1%) (但無統計顯著性)。4個試驗中有3個有住院日紀錄的試驗指出,T TUBE引流術組的住院日明顯比初步縫合組要長。唯一一個比較有支架初步縫合(37 位病人) 和T TUBE引流術(44 位病人)的試驗沒有顯示2者在任何報告的結果上存在統計學意義上的顯著差異(死亡率、再手術、傷口感染和住院日)。當中有一個案例產生支架移位,但是嘗試兩次ERCP後仍無法順利矯正。

作者結論

總膽管探查術之後實施初步縫合看似至少和T TUBE引流術一樣的安全。 我們需要隨機試驗以評估是否支架有利於該手術。

翻譯人

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

開腹總膽管探查之後實施初步縫合看似安全。當內視鏡逆行胰膽管造影術失敗或缺乏腹腔鏡總膽管探查的專家時,開腹膽總管探查是一項重要的手術。在開腹膽總管探查之後實施T TUBE引流術的主要原因有,需要術後膽管引流,視查和抽取遺留在膽管中的結石。本次系統性文獻回顧了5個隨機試驗,共324位受試者,指出初步縫合總膽管的做法看似至少和T TUBE引流術縫合一樣的安全,且可能會降低膽道感染、感染性併發症的機率、並縮短住院日數等。