Chang Stephen Kin Yong, Wang Yi Liang, Shen Liang, Iyer Shridhar Ganpathi, Shaik Ahmad Bin Syed Buhari, Lomanto Davide
Department of Surgery, National University Hospital, Singapore.
Asian J Endosc Surg. 2013 Feb;6(1):14-20. doi: 10.1111/j.1758-5910.2012.00154.x. Epub 2012 Sep 14.
Single-incision laparoscopic cholecystectomy (SILC) is increasingly practiced, but there have been no well-powered randomized trials investigating the technique. This non-inferiority trial aims to compare SILC with conventional four-port laparoscopic cholecystectomy (LC) with postoperative pain as the primary endpoint.
We aim to randomize 100 patients into equal arms of SILC or LC. Exclusion criteria were: (i) acute cholecystitis; (ii) an ASA score of 3 or above; (iii) bleeding disorders; or (iv) previous upper abdominal surgery. Patients and postoperative assessors were blinded to the procedure received. The site and severity of pain was compared based on the visual analogue scale at 4 hours, 24 hours and 14 days postoperatively; non-inferiority was assumed when the lower boundary of the 95% confidence interval of the difference was above -1, and superiority when P ≤ 0.05.
We recruited 24 SILC and 26 LC patients. There were no conversions to open cholecystectomy or from SILC to LC. SILC was non-inferior for pain at umbilical sites at rest and at extra-umbilical sites at all times. At 24 hours postoperatively, SILC was associated with significantly less pain at extra-umbilical sites (rest: P = 0.002; movement: P = 0.004). There were no incidents of biliary injury or retained gallstones. Of the 24 SILC patients, 12.5% had postoperative complications (vomiting, mild fluid overload, wound infection) compared with 0% of LC patients (P = 0.110); all complications resolved with conservative management. Operating time, analgesic use, return to function, and overall satisfaction did not differ significantly between the two groups.
SILC is associated with reduced pain and is feasible in routine surgical practice.
单孔腹腔镜胆囊切除术（SILC）的应用越来越广泛，但尚无有力的随机试验对该技术进行研究。本非劣效性试验旨在比较SILC与传统四孔腹腔镜胆囊切除术（LC），以术后疼痛作为主要终点。
我们旨在将100例患者随机分为SILC组或LC组，每组人数相等。排除标准为：（i）急性胆囊炎；（ii）美国麻醉医师协会（ASA）评分3分及以上；（iii）出血性疾病；或（iv）既往上腹部手术史。患者和术后评估人员对所接受的手术方式均不知情。根据视觉模拟量表比较术后4小时、24小时和14天时疼痛的部位和严重程度；当差异的95%置信区间下限高于-1时，认为非劣效，当P≤0.05时，认为优效。
我们招募了24例接受SILC的患者和26例接受LC的患者。没有转为开腹胆囊切除术或从SILC转为LC的情况。SILC在静息时脐部及所有时间的脐外部位疼痛方面非劣于LC。术后24小时，SILC在脐外部位的疼痛明显较轻（静息时：P = 0.002；活动时：P = 0.004）。没有发生胆漏或残留结石事件。24例接受SILC的患者中，12.5%有术后并发症（呕吐、轻度液体超负荷、伤口感染），而接受LC的患者中这一比例为0%（P = 0.110）；所有并发症经保守治疗后均得到缓解。两组在手术时间、镇痛药物使用、恢复功能情况及总体满意度方面差异均无统计学意义。
SILC可减轻疼痛，在常规外科手术中是可行的。
