Early versus delayed laparoscopic cholecystectomy for biliary colic

  • Review
  • Intervention

Authors


Abstract

Background

Biliary colic is one of the commonest indications for laparoscopic cholecystectomy. Laparoscopic cholecystectomy involves several months of waiting if performed electively. However, patients can develop life-threatening complications during this waiting period.

Objectives

To assess the benefits and harms of early versus delayed laparoscopic cholecystectomy for patients with biliary colic due to gallstones.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2008.

Selection criteria

We included only randomised clinical trials irrespective of language and publication status.

Data collection and analysis

Two authors independently extracted the data. We intended to calculate the risk ratio, risk difference with 95% confidence intervals (CI) for dichotomous outcomes, and weighted mean difference (WMD) with 95% CI for continuous outcomes using RevMan 4.2 based on intention-to-treat analysis.

Main results

Only one trial including 75 patients, randomised to early laparoscopic cholecystectomy (less than 24 hours of diagnosis) (n = 35) and delayed laparoscopic cholecystectomy (mean waiting period of 4.2 months) (n = 40), qualified for this review. This trial was of high risk of bias. During the waiting period in the delayed group (mean 4.2 months), the complications that the patients suffered included severe acute pancreatitis resulting in mortality (1), empyema of gallbladder (1), gallbladder perforation (1), acute cholecystitis (2), cholangitis (2), obstructive jaundice (2), and recurrent biliary colic requiring hospital visits (5). The rate of conversion to open cholecystectomy was lower in the early group (0%) than the delayed group (8/40 or 20%) (p = 0.0172). There was a statistically significant shorter operating time and hospital stay in the early group than the delayed group (WMD -14.80 minutes, 95% CI -18.02 to -11.58 and -1.25 days, 95% CI -2.05 to -0.45 respectively). Fourteen patients (35%) required 18 hospital admissions for symptoms related to gallstones during the mean waiting period of 4.2 months in the delayed group. This is equivalent to 11 admissions per 100 persons per month.

Authors' conclusions

Based on evidence from only one high-bias risk trial, it appears that early laparoscopic cholecystectomy (< 24 hours of diagnosis of biliary colic) decreases the morbidity during the waiting period for elective laparoscopic cholecystectomy, decreases the rate of conversion to open cholecystectomy, decreases operating time, and decreases hospital stay. Further randomised clinical trials are necessary to confirm or refute this finding.

摘要

背景

早期及延期腹腔鏡膽囊切除術治療膽管絞痛的比較

膽管絞痛是腹腔鏡膽囊切除術最常見的適應症之一。如果有選擇性的實施手術,腹腔鏡膽囊切除術則需等待幾個月。但是,在此等待期間,病人可能發展成威脅生命的併發症。

目標

評估早期及延期腹腔鏡膽囊切除術治療因膽囊結石引起的膽管絞痛病人的利弊。

搜尋策略

我們搜尋截至2008年3月之前的The Cochrane HepatoBiliary Group Controlled Trials Register, Cochrane Library的The Cochrane Central Register of Controlled Trials、 MEDLINE、EMBASE和Science Citation Index Expanded。

選擇標準

我們只收納隨機臨床試驗,不受語言和發表狀態的限制。

資料收集與分析

兩位作者獨立摘錄數據。我們計畫使用RevMan 4.2,根據治療意向,評估二分法結果的風險比率(risk ratio),風險差異(risk difference),及其95%信賴區間(CI);連續性結果以加權平均差(WMD),及95% CI計算。

主要結論

只有一個共75位病人的試驗比較早期腹腔鏡膽囊切除術 (24小時之內) (n = 35)和延期腔鏡膽囊切除術(平均等待4.2個月) (n = 40)符合本次文獻回顧的資格。本次試驗具有較高的偏誤風險。在延期組 (平均4.2個月)的等待時間裏,病人遭受的併發症包括嚴重急性胰腺炎,最終導致死亡(1),膽囊積膿(1),膽囊穿孔(1),急性膽囊炎(2), 膽管炎(2)阻塞性黃疸(2),需要住院觀察的復發性膽管絞痛(5)。早期組 (0%)開腹膽囊切除術的轉院率低於延期組(8/40或 20%) (p = 0.0172)。 和延期組(WMD −14.80 分鐘, 分別是95% CI −18.02 −11.58和−1.25 天, 95% CI −2.05 – 0.45)相比,早期組的手術時間和住院日明顯更短。延期組在平均等待的4.2個月期間,有14位病人(35%) 需要住院18次治療和膽囊結石有關的症狀。這就等於每個月每100個人裏有11個人住院。

作者結論

根據唯一一次偏誤風險高的試驗,早期腹腔鏡膽囊切除術(診斷為膽管絞痛的24小時之內)似乎能夠降低實施選擇性腹腔鏡膽囊切除術之後,等待期間的發病率,降低開腹膽囊切除術的轉院率,減少手術時間和住院日。對此發現需要進一步的隨機臨床試驗給予確認或反對。

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

對膽囊結石疼痛實施早期腹腔鏡摘除術,可以降低等待期間的發病率;降低開腹摘除膽囊的轉換率,降低手術時間和住院日,但是需要實施偏誤風險低的試驗:對症狀性膽囊結石摘除膽囊是最常見的對腹部實施的手術。腹腔鏡膽囊切除術通常在延期的基礎上治療膽囊結石疼痛(膽囊沒有發炎),例如膽管絞痛, 但是可以作為緊急手術。病人在等待手術的過程中,可能會發展成威脅生命的併發症。本次文獻回顧,我們確定一次偏見風險高的試驗(意思是,系統誤差的風險較高),隨機挑選 75 位有膽管絞痛需要立即手術(診斷後24小時內)或擇期手術 (平均等待4.2個月)的病人。由於擇期手術組在等待手術期間,出現和膽囊結石有關的併發症,所以14位病人(35%)至少需要緊急入院治療一次。總體看,4.2個月內,40位病人有18位病人住院治療。這就等於每個月100位病人裏有11個人住院治療。擇期手術導致更多的人需要開腹手術 (擇期手術組20%比照緊急手術組0%);手術時間 (擇期手術組大約增加15分鐘)和住院日 (擇期手術組延長1天)更長。 需要實施進一步的低偏差風險(系統誤差的低風險)隨機臨床試驗。

Plain language summary

Early key hole removal of gallbladder for gallstone pain decreases morbidity during the waiting period; conversion to open removal of gallbladder; and decreases operating time and hospital stay but further low bias-risk trials are necessary

Removal of gallbladder (cholecystectomy) for symptomatic gallstones is one of the commonest abdominal operations performed. Key-hole removal of the gallbladder (laparoscopic cholecystectomy) is usually performed on a delayed (elective) basis for gallstone pain (without gallbladder inflammation), ie, biliary colic, but can be performed as an emergency surgery. Patients can develop life threatening complications while waiting for surgery. In this review, we identified one trial of high bias-risk (meaning that there is a high risk of systematic error), which randomised 75 patients with biliary colic to immediate surgery (less than 24 hours of diagnosis) or to elective surgery (mean waiting time 4.2 months). Fourteen patients (35%) required at least one emergency hospital admission for complications related to gallstones during the waiting period in the elective surgery group. In total, there were 18 admissions in 40 patients in 4.2 months. This is equivalent to 11 admissions for 100 patients per month. Elective surgery resulted in more people requiring open operations (20% elective surgery group compared with none in emergency surgery group); and longer operating time (increased by about 15 minutes in the elective surgery group) and hospital stay (increased by one day in the elective surgery group). Further randomised clinical trials of low bias-risk (meaning that they should have low risk of systematic error) are needed.

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