Gurusamy Kurinchi Selvan, Koti Rahul, Fusai Giuseppe, Davidson Brian R
Department of Surgery, Royal Free Campus, UCL Medical School, London, UK.
Cochrane Database Syst Rev. 2013 Jun 30;2013(6):CD007196. doi: 10.1002/14651858.CD007196.pub3.
Uncomplicated biliary colic is one of the commonest indications for laparoscopic cholecystectomy. Laparoscopic cholecystectomy involves several months of waiting if performed electively. However, people can develop life-threatening complications during this waiting period.
To assess the benefits and harms of early versus delayed laparoscopic cholecystectomy for people with uncomplicated biliary colic due to gallstones.
We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2013.
We included only randomised clinical trials, irrespective of language and publication status.
Two authors independently extracted the data. We sought to include data on short-term mortality (30-day mortality or in-hospital mortality), bile duct injury, other serious adverse events, quality of life, conversion to open cholecystectomy, length of hospital stay, operating time, and return to work. We planned to calculate the risk ratio with 95% confidence interval (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous outcomes using RevMan and based on intention-to-treat analysis when data were available. Since only one trial contributed data to this review, Fisher's exact test was used for binary outcomes. A P value of < 0.05 was considered statistically significant.
Only one trial including 75 participants (average age: 43 years; females: 65% of participants), randomised to early laparoscopic cholecystectomy (less than 24 hours after diagnosis) (n = 35) or delayed laparoscopic cholecystectomy (mean waiting period of 4.2 months) (n = 40), contributed information to this review. The trial had a high risk of bias. Information on the outcome mortality was available for the 75 participants. Information on serious adverse events was available for 68 participants (28 people in the early group and 40 people in the delayed group). The other outcomes were available for 28 participants in the early laparoscopic cholecystectomy group and 35 participants in the delayed laparoscopic cholecystectomy group. There were no deaths in the early group (0/35) (0%) versus 1/40 (2.5%) in the delayed laparoscopic cholecystectomy group (P > 0.9999). There was no bile duct injury in either group. There were no serious adverse events related to the surgery in either group. During the waiting period, complications developed in the delayed laparoscopic cholecystectomy group. The complications that the participants suffered included pancreatitis (n = 1), empyema of the gallbladder (n = 1), gallbladder perforation (n = 1), acute cholecystitis (n = 2), cholangitis (n = 2), obstructive jaundice (n = 2), and recurrent biliary colic (requiring hospital visits) (n = 5). In total, 14 participants required hospital admissions for the above symptoms. All of these admissions occurred in the delayed group as all the participants were operated on within 24 hours in the early group. The proportion of people who developed serious adverse events was 0/28 (0%) in the early group, which was significantly lower than in the delayed laparoscopic cholecystectomy group 9/40 (22.5%) (P = 0.0082). This trial did not report quality of life or return to work. There was no significant difference in the proportion of people who required conversion to open cholecystectomy in the early group 0/28 (0%) compared with the delayed group (6/35 or 17.1%) (P = 0.0743). There was a statistically significant shorter hospital stay in the early group than in the delayed group (MD -1.25 days, 95% CI -2.05 to -0.45). There was a statistically significant shorter operating time in the early group than the delayed group (MD -14.80 minutes, 95% CI -18.02 to -11.58).
AUTHORS' CONCLUSIONS: Based on evidence from only one high-bias risk trial, it appears that early laparoscopic cholecystectomy (less than 24 hours after diagnosis of biliary colic) decreases the morbidity during the waiting period for elective laparoscopic cholecystectomy (mean waiting time 4.2 months), the hospital stay, and operating time. Further randomised clinical trials are necessary to confirm or refute these findings, and to determine if early laparoscopic cholecystectomy is better than the delayed laparoscopic cholecystectomy if the waiting time is shortened further.
单纯性胆绞痛是腹腔镜胆囊切除术最常见的指征之一。如果择期进行腹腔镜胆囊切除术,需要等待数月。然而,在此等待期间,患者可能会出现危及生命的并发症。
评估对于因胆结石导致单纯性胆绞痛的患者,早期与延迟腹腔镜胆囊切除术的益处和危害。
我们检索了截至2013年3月的Cochrane图书馆中的Cochrane对照试验中央注册库、MEDLINE、EMBASE和科学引文索引扩展版。
我们仅纳入随机临床试验,不考虑语言和发表状态。
两位作者独立提取数据。我们试图纳入关于短期死亡率(30天死亡率或住院死亡率)、胆管损伤、其他严重不良事件、生活质量、转为开腹胆囊切除术、住院时间、手术时间和恢复工作的数据。当有数据时,我们计划使用RevMan基于意向性分析计算二分结局的风险比及95%置信区间(CI),以及连续结局的平均差(MD)及95%CI。由于只有一项试验为本次综述提供了数据,因此对于二元结局使用Fisher精确检验。P值<0.05被认为具有统计学意义。
仅有一项试验纳入了75名参与者(平均年龄:43岁;女性:占参与者的65%),随机分为早期腹腔镜胆囊切除术组(诊断后不到24小时)(n = 35)和延迟腹腔镜胆囊切除术组(平均等待期4.2个月)(n = 40),为本综述提供了信息。该试验存在较高的偏倚风险。75名参与者中有关于死亡率结局的信息。68名参与者(早期组28人,延迟组40人)有关于严重不良事件的信息。早期腹腔镜胆囊切除术组的28名参与者和延迟腹腔镜胆囊切除术组的35名参与者有其他结局的信息。早期组无死亡(0/35)(0%),而延迟腹腔镜胆囊切除术组有1/40(2.5%)死亡(P>0.9999)。两组均无胆管损伤。两组均无与手术相关的严重不良事件。在等待期间,延迟腹腔镜胆囊切除术组出现了并发症。参与者所患并发症包括胰腺炎(n = 1)、胆囊积脓(n = 1)、胆囊穿孔(n = 1)、急性胆囊炎(n = 2)、胆管炎(n = 2)、梗阻性黄疸(n = 2)和复发性胆绞痛(需要住院就诊)(n = 5)。共有14名参与者因上述症状需要住院治疗。所有这些住院情况均发生在延迟组,因为早期组的所有参与者均在24小时内接受了手术。早期组发生严重不良事件的比例为0/28(0%),显著低于延迟腹腔镜胆囊切除术组的9/40(22.5%)(P = 0.0082)。该试验未报告生活质量或恢复工作情况。早期组需要转为开腹胆囊切除术的比例为0/28(0%),与延迟组(6/35或17.1%)相比无显著差异(P = 0.0743)。早期组的住院时间在统计学上显著短于延迟组(MD -1.25天,95%CI -2.05至-0.45)。早期组的手术时间在统计学上显著短于延迟组(MD -14.80分钟,95%CI -18.02至-11.58)。
基于仅一项高偏倚风险试验的证据,早期腹腔镜胆囊切除术(胆绞痛诊断后不到24小时)似乎可降低择期腹腔镜胆囊切除术等待期(平均等待时间4.2个月)的发病率、住院时间和手术时间。需要进一步的随机临床试验来证实或反驳这些发现,并确定如果进一步缩短等待时间,早期腹腔镜胆囊切除术是否优于延迟腹腔镜胆囊切除术。