Departments of Surgery, Bispebjerg Hospital, Copenhagen.
Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.
There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen.
This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3.
The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001).
SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting.
NCT01268748 (http://www.clinicaltrials.gov).
在优化围手术期镇痛方案下，尚无比较单切口（SLC）与传统多切口（MLC）腹腔镜胆囊切除术术后结果的随机研究。
本患者和评估者设盲的三中心随机临床试验比较了选择性胆囊结石症女性患者的 SLC 和 MLC。结果于手术日（第 0 天）、术后第 1、2、3 天和第 30 天以及术后 12 个月进行登记。患者的盲法一直维持到第 3 天。主要终点是患者反复报告的视觉模拟评分法（VAS）测量的运动时疼痛。
意向治疗人群中 SLC 组和 MLC 组分别有 59 例和 58 例。两组之间在任何与疼痛相关的结果、按需使用阿片类药物或一般不适方面均无显著差异。SLC 组手术时间中位数长 32.5 分钟（P<0.001）。SLC 与术后第 0 天呕吐发生率降低相关（7%比 22%；P=0.019）。与切口相关的问题发生率相似。SLC 组有 1 例患者发生需要内镜逆行胰胆管造影的胆漏。两组在 12 个月随访时的切口疝发生率均为 2%。SLC 在 1 和 12 个月时的美容评分显著改善（P<0.001）。
在优化围手术期镇痛患者护理的情况下，SLC 并未显著减轻早期疼痛。SLC 可能减少术后呕吐。
NCT01268748（http://www.clinicaltrials.gov）。
