Maastricht University Medical Centre, Maastricht University, P.Debyelaan 25, PO Box 5800, 6202 AZ, Maastricht, The Netherlands.
Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
Surg Endosc. 2017 Sep;31(9):3437-3448. doi: 10.1007/s00464-016-5381-0. Epub 2016 Dec 30.
Single-incision laparoscopic cholecystectomy (SILC) might maximize the advantages of laparoscopic cholecystectomy (LC) by reducing postoperative pain and improving cosmesis. However, the safety and feasibility of SILC has not yet been established. This study assesses safety, patient reported outcome measures and feasibility of SILC versus conventional LC.
Literature search for RCT's comparing SILC with conventional LC in gallstone-related disease was performed in PubMed and Embase. The conventional LC was defined as two 10-mm and two 5-mm ports. Study selection was done according to predefined criteria. Two reviewers assessed the risk of bias. Pooled outcomes were calculated for adverse events, pain, cosmesis, quality of life and feasibility using fixed-effect and random-effects models.
Nine RCT's were included with total of 860 patients. No mortality was observed. More mild adverse events (RR 1.55; 95% CI 0.99-2.42) and significantly more serious adverse events (RR 3.00; 95% CI 1.05-8.58) occurred in the SILC group. Postoperative pain (MD -0.46; 95% CI -0.74 to -0.18) and cosmesis (SMD 2.38; 95% CI 1.50-3.26) showed significantly better results for the SILC group, but no differences were observed in quality of life. Operating time (MD 23.12; 95% CI 11.59-34.65) and the need for additional ports (RR 11.43; 95% CI 3.48-37.50) were significantly higher in the SILC group. No difference was observed in conversion to open cholecystectomy or hospital stay longer than 24 h.
SILC does not provide any clear advantages over conventional LC except for less postoperative pain and improved cosmesis. It is questionable whether these advantages outweigh the higher occurrence of adverse events and shortcomings in feasibility. Considering considerable heterogeneity and low methodological quality of the studies it is advisable to perform well-designed RCT's in the future to address the safety and clinical benefits of SILC.
单切口腹腔镜胆囊切除术(SILC)通过减少术后疼痛和改善美容效果,最大限度地发挥腹腔镜胆囊切除术(LC)的优势。然而,SILC 的安全性和可行性尚未得到证实。本研究评估 SILC 与传统 LC 治疗胆囊疾病的安全性、患者报告的结果测量指标和可行性。
在 PubMed 和 Embase 中对比较 SILC 与传统 LC 治疗胆囊疾病的 RCT 进行文献检索。传统 LC 定义为两个 10mm 和两个 5mm 端口。根据预设标准进行研究选择。两名评审员评估了偏倚风险。使用固定效应和随机效应模型计算不良事件、疼痛、美容效果、生活质量和可行性的汇总结果。
纳入了 9 项 RCT,共 860 例患者。未观察到死亡病例。SILC 组中更常见轻度不良事件(RR 1.55;95%CI 0.99-2.42)和更严重的不良事件(RR 3.00;95%CI 1.05-8.58)。SILC 组术后疼痛(MD -0.46;95%CI -0.74 至 -0.18)和美容效果(SMD 2.38;95%CI 1.50-3.26)显著更好,但生活质量无差异。SILC 组的手术时间(MD 23.12;95%CI 11.59-34.65)和需要额外端口(RR 11.43;95%CI 3.48-37.50)明显更高。中转开腹胆囊切除术或住院时间超过 24 小时的比例无差异。
除了术后疼痛减轻和美容效果改善外,SILC 并未为传统 LC 提供任何明显优势。这些优势是否超过不良事件发生率增加和可行性不足,尚不清楚。考虑到研究的异质性较大且方法学质量较低,建议未来开展设计良好的 RCT,以解决 SILC 的安全性和临床获益问题。