Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, People's Republic of China.
Department of General Surgery, Gansu Provincial Hospital, Lanzhou, 730000, Gansu Province, People's Republic of China.
Surg Endosc. 2017 Dec;31(12):4950-4963. doi: 10.1007/s00464-017-5610-1. Epub 2017 Jun 7.
Currently, there is no consensus on whether laparoscopic cholecystectomy (LC) performed as day-surgery is safe and effective and can be considered as the standard for the management of symptomatic gallbladder disease. We conducted a meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and effectiveness of this intervention based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
We conducted a systematic search of several databases from their inception to November 10, 2016 for entries on the mortality, morbidity after discharge, readmission, postoperative morbidity, and patient satisfaction at 1 week of day-surgery LC. Pooled risk ratio (RR) with 95% confidence intervals (CI) was calculated using the fixed-effects model. Rare outcomes were presented as the Peto odds ratio (Peto OR). Meta-analysis was performed by using the RevMan 5.1 software, and the level of evidence was assessed by using the GRADE guideline and GRADEpro GDT software.
Eight RCTs totaling 624 participants were included. The result showed no intergroup difference in short-term mortality. Compared to overnight-stay surgery, day-surgery did not show any clear evidence of reduced morbidity after discharge (Peto OR 0.89; 95% CI 0.39-2.02), lower readmission rate (Peto OR 0.68; 95% CI 0.23-2.05), or higher postoperative morbidity rates (RR 1.28; 95% CI 0.81-2.02). However, the results suggested that day-surgery may improve patient satisfaction at 1 week (RR 1.17; 95% CI 1.03-1.33). Evaluation by the GRADE approach revealed that the quality of evidence for each outcome was of low to very low quality due to the risk of bias, imprecision, and inconsistency.
Our meta-analysis shows that the safety and effectiveness of day-surgery LC is still uncertain. Additional well-designed and adequately powered RCTs are required before the procedure can be recommended as the standard for clinical practice.
目前,对于腹腔镜胆囊切除术(LC)日间手术是否安全有效,能否作为有症状胆囊疾病的标准治疗方法,尚无共识。我们使用推荐评估、制定与评价(GRADE)方法对随机对照试验(RCT)进行了荟萃分析,以评估这种干预措施的安全性和有效性。
我们对多个数据库进行了系统检索,检索时间从数据库建立至 2016 年 11 月 10 日,以获取日间 LC 术后 1 周时死亡率、出院后发病率、再入院率、术后发病率和患者满意度的相关信息。使用固定效应模型计算汇总风险比(RR)及其 95%置信区间(CI)。罕见结局则采用 Peto 比值比(Peto OR)表示。使用 RevMan 5.1 软件进行荟萃分析,并使用 GRADE 指南和 GRADEpro GDT 软件评估证据水平。
纳入 8 项 RCT,共 624 例患者。结果显示,两组间短期死亡率无差异。与过夜住院手术相比,日间手术并未显示出在降低出院后发病率(Peto OR 0.89;95%CI 0.39-2.02)、降低再入院率(Peto OR 0.68;95%CI 0.23-2.05)或提高术后发病率(RR 1.28;95%CI 0.81-2.02)方面有明显优势。然而,日间手术可能在术后 1 周时提高患者满意度(RR 1.17;95%CI 1.03-1.33)。采用 GRADE 方法评价发现,由于偏倚风险、不精确性和一致性问题,每种结局的证据质量均为低质量或极低质量。
本荟萃分析表明,日间 LC 的安全性和有效性仍不确定。需要进一步开展设计良好且充分有力的 RCT,才能推荐该术式作为临床实践的标准。