Department of Hepato-Biliary-Pancreatic and Breast Surgery, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan.
Department of Hepato-Biliary-Pancreatic and Breast Surgery, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan.
Surgery. 2019 Feb;165(2):353-359. doi: 10.1016/j.surg.2018.08.004. Epub 2018 Oct 9.
Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life.
This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time.
A total of 58 patients in the single-incision group and 53 in the 4-port group (n = 111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval -0.4 to 3.2, P = .12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy.
Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy.
单切口腹腔镜胆囊切除术（通过脐部的稍大切口）与更为经典的四孔腹腔镜胆囊切除术相比，是否会导致术后生活质量更差和疼痛更明显，目前仍存在争议。本研究旨在从生活质量的角度比较单切口和四孔腹腔镜胆囊切除术。
本研究为多中心、平行组、开放标签、随机临床试验。共纳入 120 例拟行择期胆囊切除术的患者，按照 1:1 随机分配至单切口腹腔镜胆囊切除术组或四孔腹腔镜胆囊切除术组，然后在术后 2 周内持续进行评估。主要结局为生活质量，定义为恢复正常日常活动的时间。还评估了术后疼痛。为了探索治疗效果的异质性，我们评估了性别、年龄和工作状态对恢复时间的交互作用。
共有 58 例患者入组单切口组，53 例患者入组四孔组（n=111，47 例男性，平均年龄 57 岁）。单切口组和四孔组恢复日常活动的中位时间分别为 10.2 天和 8.8 天（95%置信区间 -0.4 至 3.2，P=0.12）。同样，两组间术后疼痛缓解时间也无显著差异。但观察到了统计学上不显著但具有定性意义的交互作用；在女性、全职工作者和年龄小于 60 岁的亚组中，单切口腹腔镜胆囊切除术后恢复时间似乎较慢。
单切口腹腔镜胆囊切除术和四孔腹腔镜胆囊切除术术后生活质量无显著差异。年龄小于 60 岁、女性和全职工作者在接受单切口腹腔镜胆囊切除术后恢复时间可能会稍长。
