Vaughan Jessica, Gurusamy Kurinchi Selvan, Davidson Brian R
Department of Surgery, Royal Free Campus, UCL Medical School, London, UK.
Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD006798. doi: 10.1002/14651858.CD006798.pub4.
Laparoscopic cholecystectomy is used to manage symptomatic gallstones. There is considerable controversy regarding whether it should be done as day-surgery or as an overnight stay surgery with regards to patient safety.
To assess the impact of day-surgery versus overnight stay laparoscopic cholecystectomy on patient-oriented outcomes such as mortality, severe adverse events, and quality of life.
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 mRCT until September 2012.
We included randomised clinical trials comparing day-surgery versus overnight stay surgery for laparoscopic cholecystectomy, irrespective of language or publication status.
Two authors independently assessed trials for inclusion and independently extracted the data. We analysed the data with both the fixed-effect and the random-effects models using Review Manager 5 analysis. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CI) based on intention-to-treat or available case analysis.
We identified a total of six trials at high risk of bias involving 492 participants undergoing day-case laparoscopic cholecystectomy (n = 239) versus overnight stay laparoscopic cholecystectomy (n = 253) for symptomatic gallstones. The number of participants in each trial ranged from 28 to 150. The proportion of women in the trials varied between 74% and 84%. The mean or median age in the trials varied between 40 and 47 years.With regards to primary outcomes, only one trial reported short-term mortality. However, the trial stated that there were no deaths in either of the groups. We inferred from the other outcomes that there was no short-term mortality in the remaining trials. Long-term mortality was not reported in any of the trials. There was no significant difference in the rate of serious adverse events between the two groups (4 trials; 391 participants; 7/191 (weighted rate 1.6%) in the day-surgery group versus 1/200 (0.5%) in the overnight stay surgery group; rate ratio 3.24; 95% CI 0.74 to 14.09). There was no significant difference in quality of life between the two groups (4 trials; 333 participants; SMD -0.11; 95% CI -0.33 to 0.10).There was no significant difference between the two groups regarding the secondary outcomes of our review: pain (3 trials; 175 participants; MD 0.02 cm visual analogue scale score; 95% CI -0.69 to 0.73); time to return to activity (2 trials, 217 participants; MD -0.55 days; 95% CI -2.18 to 1.08); and return to work (1 trial, 74 participants; MD -2.00 days; 95% CI -10.34 to 6.34). No significant difference was seen in hospital readmission rate (5 trials; 464 participants; 6/225 (weighted rate 0.5%) in the day-surgery group versus 5/239 (2.1%) in the overnight stay surgery group (rate ratio 1.25; 95% CI 0.43 to 3.63) or in the proportion of people requiring hospital readmissions (3 trials; 290 participants; 5/136 (weighted proportion 3.5%) in the day-surgery group versus 5/154 (3.2%) in the overnight stay surgery group; RR 1.09; 95% CI 0.33 to 3.60). No significant difference was seen in the proportion of failed discharge (failure to be discharged as planned) between the two groups (5 trials; 419 participants; 42/205 (weighted proportion 19.3%) in the day-surgery group versus 43/214 (20.1%) in the overnight stay surgery group; RR 0.96; 95% CI 0.65 to 1.41). For all outcomes except pain, the accrued information was far less than the diversity-adjusted required information size to exclude random errors.
AUTHORS' CONCLUSIONS: Day-surgery appears just as safe as overnight stay surgery in laparoscopic cholecystectomy. Day-surgery does not seem to result in improvement in any patient-oriented outcomes such as return to normal activity or earlier return to work. The randomised clinical trials backing these statements are weakened by risks of systematic errors (bias) and risks of random errors (play of chance). More randomised clinical trials are needed to assess the impact of day-surgery laparoscopic cholecystectomy on the quality of life as well as other outcomes of patients.
腹腔镜胆囊切除术用于治疗有症状的胆结石。关于就患者安全而言,该手术应作为日间手术还是过夜留院手术存在相当大的争议。
评估日间手术与过夜留院腹腔镜胆囊切除术对以患者为导向的结局(如死亡率、严重不良事件和生活质量)的影响。
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和mRCT,检索截至2012年9月。
我们纳入了比较腹腔镜胆囊切除术日间手术与过夜留院手术的随机临床试验,无论语言或发表状态如何。
两位作者独立评估试验是否纳入并独立提取数据。我们使用Review Manager 5分析软件,采用固定效应模型和随机效应模型对数据进行分析。我们根据意向性治疗或可用病例分析计算风险比(RR)、平均差(MD)或标准化平均差(SMD)以及95%置信区间(CI)。
我们共识别出6项存在高偏倚风险的试验,涉及492例因有症状胆结石接受日间腹腔镜胆囊切除术(n = 239)与过夜留院腹腔镜胆囊切除术(n = 253)的参与者。每项试验的参与者数量从28至150不等。试验中女性比例在74%至84%之间。试验中的平均或中位年龄在40至47岁之间。关于主要结局,仅有一项试验报告了短期死亡率。然而,该试验称两组均无死亡病例。我们从其他结局推断,其余试验中也无短期死亡病例。所有试验均未报告长期死亡率。两组严重不良事件发生率无显著差异(4项试验;391名参与者;日间手术组7/191(加权率1.6%),过夜留院手术组1/200(0.5%);率比3.24;95% CI 0.74至14.09)。两组生活质量无显著差异(4项试验;333名参与者;SMD -0.11;95% CI -0.33至0.10)。我们综述的次要结局在两组间无显著差异:疼痛(3项试验;175名参与者;MD 0.02 cm视觉模拟量表评分;95% CI -0.69至0.73);恢复活动时间(2项试验,217名参与者;MD -0.55天;95% CI -2.18至1.08);以及恢复工作时间(1项试验,74名参与者;MD -2.00天;95% CI -10.34至6.34)。两组的再次入院率无显著差异(5项试验;464名参与者;日间手术组6/225(加权率0.5%),过夜留院手术组5/239(2.1%)(率比1.25;95% CI 0.43至3.63))或再次入院人群比例无显著差异(3项试验;290名参与者;日间手术组5/136(加权比例3.5%),过夜留院手术组5/154(3.2%);RR 1.09;95% CI 0.33至3.60)。两组间计划出院失败(未能按计划出院)比例无显著差异(5项试验;419名参与者;日间手术组42/205(加权比例19.3%),过夜留院手术组43/214(20.1%);RR 0.96;95% CI 0.65至1.41)。除疼痛外,所有结局累积的信息远少于排除随机误差所需的经多样性调整的信息规模。
在腹腔镜胆囊切除术中,日间手术似乎与过夜留院手术一样安全。日间手术似乎并未使任何以患者为导向的结局(如恢复正常活动或更早恢复工作)得到改善。支持这些说法的随机临床试验因存在系统误差(偏倚)风险和随机误差(机遇作用)风险而受到削弱。需要更多随机临床试验来评估日间腹腔镜胆囊切除术对患者生活质量以及其他结局的影响。