Laparoscopic cholecystectomy (key hole removal of gallbladder) is currently the preferred method of treatment of gallstones. During laparoscopic cholecystectomy, it is necessary to occlude the cystic duct (duct connecting the gallbladder and the bile duct) permanently. A total of three trials including 255 patients qualified for this review of randomised clinical trials. Two trials randomised 150 patients in total to absorbable clips (n = 75) and non-absorbable clips (n = 75). A third trial randomised a total of 105 patients to absorbable ligatures (n = 53) and non-absorbable clips (n = 52). All three trials were of high risk of bias. There was no difference in the morbidity between the groups. The operating time was 12 minutes longer in the absorbable ligature group than in the group randomised to non-absorbable clips.The duration and method of follow-up were not adequate to determine the incidence of long-term complications. We are unable to determine the benefits and harms of different methods of cystic duct occlusion because of the small sample size, short period of follow-up, and lack of reporting of important outcomes in the included trials. New trials with long periods of follow-up and assessing the important outcomes are necessary. Such trials should be designed well to decrease the risk of random errors and systematic errors.
阅读完整摘要
During laparoscopic cholecystectomy, it is necessary to occlude the cystic duct permanently. Traditionally, this has been performed through the application of non-absorbable metal clips. Use of absorbable materials to occlude the cystic duct has been suggested as an alternative for metal clips for various reasons.
研究目的
To assess the benefits and harms of the different methods of occlusion of cystic duct in patients undergoing laparoscopic cholecystectomy.
检索策略
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 August 2010.
纳入排除标准
We included all randomised clinical trials comparing different methods of occlusion of cystic duct.
资料收集与分析
We collected the data on the characteristics, methodological quality, bile duct injury, bile leaks, operating time, and incidence of recurrent common bile duct stone 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 risk ratio (RR) in the presence of more than one trial for the outcome or mean difference (MD) with 95% confidence intervals (CI) based on intention-to-treat analysis. In the presence of only one trial under a dichotomous outcome, we performed the Fisher's exact test.
主要结果
Three trials including 255 patients qualified for this review. In two of the trial, a total of 150 patients were randomised to absorbable clips (n = 75) and non-absorbable clips (n = 75). In the third trial, a total of 105 patients were randomised to absorbable ligatures (n = 53) and non-absorbable clips (n = 52). All three trials were of high risk of bias. There was no difference in the morbidity between the groups. There was statistically significant longer operating time (MD 12.00 minutes, 95% CI 1.59 to 22.41) in the absorbable ligature group than non-absorbable clips. The duration and method of follow-up were not adequate to determine the incidence of long-term complications.
作者结论
We are unable to determine the benefits and harms of different methods of cystic duct occlusion because of the small sample size, short period of follow-up, and lack of reporting of important outcomes in the included trials. Adequately powered randomised trials with low risk of bias and with long periods of follow-up and assessing all of the important outcomes for patients and professionals are necessary.
