Gurusamy Kurinchi Selvan, Davidson Christopher, Gluud Christian, Davidson Brian R
Department of Surgery, Royal Free Campus, UCLMedical School, London, UK.
Cochrane Database Syst Rev. 2013 Jun 30(6):CD005440. doi: 10.1002/14651858.CD005440.pub3.
Gallstones are present in about 10% to 15% of the adult western population. Between 1% and 4% of these adults become symptomatic in a year (the majority due to biliary colic but a significant proportion due to acute cholecystitis). Laparoscopic cholecystectomy for acute cholecystitis is mainly performed after the acute cholecystitis episode settles because of the fear of higher morbidity and of need for conversion from laparoscopic to open cholecystectomy. However, delaying surgery exposes the people to gallstone-related complications.
The aim of this systematic review was to compare early laparoscopic cholecystectomy (less than seven days of clinical presentation with acute cholecystitis) versus delayed laparoscopic cholecystectomy (more than six weeks after index admission with acute cholecystitis) with regards to benefits and harms.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and World Health Organization International Clinical Trials Registry Platform until July 2012.
We included all randomised clinical trials comparing early versus delayed laparoscopic cholecystectomy in participants with acute cholecystitis.
We used standard methodological procedures expected by The Cochrane Collaboration.
We identified seven trials that met the inclusion criteria. Out of these, six trials provided data for the meta-analyses. A total of 488 participants with acute cholecystitis and fit to undergo laparoscopic cholecystectomy were randomised to early laparoscopic cholecystectomy (ELC) (244 people) and delayed laparoscopic cholecystectomy (DLC) (244 people) in the six trials. Blinding was not performed in any of the trials and so all the trials were at high risk of bias. Other than blinding, three of the six trials were at low risk of bias in the other domains such as sequence generation, allocation concealment, incomplete outcome data, and selective outcome reporting. The proportion of females ranged between 43.3% and 80% in the trials that provided this information. The average age of participants ranged between 40 years and 60 years. There was no mortality in any of the participants in five trials that reported mortality. There was no significant difference in the proportion of people who developed bile duct injury in the two groups (ELC 1/219 (adjusted proportion 0.4%) versus DLC 2/219 (0.9%); Peto OR 0.49; 95% CI 0.05 to 4.72 (5 trials)). There was no significant difference between the two groups (ELC 14/219 (adjusted proportion 6.5%) versus DLC 11/219 (5.0%); RR 1.29; 95% CI 0.61 to 2.72 (5 trials)) in terms of other serious complications. None of the trials reported quality of life from the time of randomisation. There was no significant difference between the two groups in the proportion of people who required conversion to open cholecystectomy (ELC 49/244 (adjusted proportion 19.7%) versus DLC 54/244 (22.1%); RR 0.89; 95% CI 0.63 to 1.25 (6 trials)). The total hospital stay was shorter in the early group than the delayed group by four days (MD -4.12 days; 95% CI -5.22 to -3.03 (4 trials; 373 people)). There was no significant difference in the operating time between the two groups (MD -1.22 minutes; 95% CI -3.07 to 0.64 (6 trials; 488 people)). Only one trial reported return to work. The people belonging to the ELC group returned to work earlier than the DLC group (MD -11.00 days; 95% CI -19.61 to -2.39 (1 trial; 36 people)). Four trials did not report any gallstone-related morbidity during the waiting period. One trial reported five gallstone-related morbidities (cholangitis: two; biliary colic not requiring urgent operation: one; acute cholecystitis not requiring urgent operation: two). There were no reports of pancreatitis during the waiting time. Gallstone-related morbidity was not reported in the remaining trials. Forty (18.3%) of the people belonging to the delayed group had either non-resolution of symptoms or recurrence of symptoms before their planned operation and had to undergo emergency laparoscopic cholecystectomy in five trials. The proportion with conversion to open cholecystectomy was 45% (18/40) in this group of people.
AUTHORS' CONCLUSIONS: We found no significant difference between early and late laparoscopic cholecystectomy on our primary outcomes. However, trials with high risk of bias indicate that early laparoscopic cholecystectomy during acute cholecystitis seems safe and may shorten the total hospital stay. The majority of the important outcomes occurred rarely, and hence the confidence intervals are wide. It is unlikely that future randomised clinical trials will be powered to measure differences in bile duct injury and other serious complications since this might involve performing a trial of more than 50,000 people, but several smaller randomised trials may answer the questions through meta-analyses.
在西方成年人群中,约10%至15%的人患有胆结石。这些成年人中,每年有1%至4%会出现症状(大多数是由于胆绞痛,但相当一部分是由于急性胆囊炎)。由于担心更高的发病率以及需要从腹腔镜胆囊切除术转为开腹胆囊切除术,急性胆囊炎的腹腔镜胆囊切除术主要在急性胆囊炎发作缓解后进行。然而,延迟手术会使患者面临与胆结石相关的并发症。
本系统评价的目的是比较早期腹腔镜胆囊切除术(急性胆囊炎临床表现少于7天)与延迟腹腔镜胆囊切除术(急性胆囊炎首次入院后超过6周)的益处和危害。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、科学引文索引扩展版以及世界卫生组织国际临床试验注册平台,检索截至2012年7月。
我们纳入了所有比较急性胆囊炎患者早期与延迟腹腔镜胆囊切除术的随机临床试验。
我们采用了Cochrane协作网期望的标准方法程序。
我们确定了7项符合纳入标准的试验。其中,6项试验提供了荟萃分析的数据。在这6项试验中,共有488例适合进行腹腔镜胆囊切除术的急性胆囊炎患者被随机分为早期腹腔镜胆囊切除术(ELC)组(244人)和延迟腹腔镜胆囊切除术(DLC)组(244人)。所有试验均未实施盲法,因此所有试验均存在高偏倚风险。除盲法外,6项试验中的3项在序列生成、分配隐藏、不完整结局数据和选择性结局报告等其他领域存在低偏倚风险。提供该信息的试验中,女性比例在43.3%至80%之间。参与者的平均年龄在40岁至60岁之间。报告死亡率的5项试验中,所有参与者均无死亡。两组发生胆管损伤的比例无显著差异(ELC组1/219(调整比例0.4%),DLC组2/219(0.9%);Peto比值比0.49;95%可信区间0.05至4.72(5项试验))。两组在其他严重并发症方面无显著差异(ELC组14/219(调整比例6.5%),DLC组11/219(5.0%);风险比1.29;95%可信区间0.61至2.72(5项试验))。没有试验从随机分组时起报告生活质量。两组中需要转为开腹胆囊切除术的比例无显著差异(ELC组49/244(调整比例19.7%),DLC组54/244(22.1%);风险比0.89;95%可信区间0.63至1.25(6项试验))。早期组的总住院时间比延迟组短4天(平均差-4.12天;95%可信区间-5.22至-3.03(4项试验;373人))。两组手术时间无显著差异(平均差-1.22分钟;95%可信区间-3.07至0.64(6项试验;488人))。只有1项试验报告了恢复工作情况。ELC组的人比DLC组更早恢复工作(平均差-11.00天;95%可信区间-19.61至-2.39(1项试验;36人))。4项试验未报告等待期内任何与胆结石相关的发病率。1项试验报告了5例与胆结石相关的发病情况(胆管炎:2例;无需紧急手术的胆绞痛:1例;无需紧急手术的急性胆囊炎:2例)。等待期内无胰腺炎报告。其余试验未报告与胆结石相关的发病率。在5项试验中,延迟组中有40例(18.3%)患者在计划手术前症状未缓解或复发,不得不接受急诊腹腔镜胆囊切除术。在这组患者中,转为开腹胆囊切除术的比例为45%(18/40)。
我们发现早期和晚期腹腔镜胆囊切除术在主要结局方面无显著差异。然而,存在高偏倚风险的试验表明,急性胆囊炎期间早期腹腔镜胆囊切除术似乎是安全的,并且可能缩短总住院时间。大多数重要结局很少发生,因此可信区间较宽。未来的随机临床试验不太可能有足够的效力来测量胆管损伤和其他严重并发症的差异,因为这可能需要进行超过50000人的试验,但几项较小的随机试验可能通过荟萃分析回答这些问题。