Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.
Department of General and Visceral Surgery, Evangelische Elisabeth Klinik, Lützowstraße 26, 10785, Berlin, Germany.
Langenbecks Arch Surg. 2020 Aug;405(5):551-561. doi: 10.1007/s00423-020-01911-1. Epub 2020 Jun 29.
Within the last years, single-incision laparoscopic cholecystectomy (SLC) emerged as an alternative to multiport laparoscopic cholecystectomy (MLC). SLC has advantages in cosmetic results, and postoperative pain seems lower. Overall complications are comparable between SLC and MLC. However, long-term results of randomized trials are lacking, notably to answer questions about incisional hernia rates, long-term cosmetic impact and chronic pain.
A randomized trial of SLC versus MLC with a total of 193 patients between December 2009 and June 2011 was performed. The primary endpoint was postoperative pain on the first day after surgery. Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. A long-term follow-up after surgery was added.
Ninety-eight patients (50.8%) underwent SLC, and 95 patients (49.2%) had MLC. Pain on the first postoperative day showed no difference between the operative procedures (SLC vs. MLC, 3.4 ± 1.8 vs. 3.7 ± 1.9, respectively; p = 0.317). No significant differences were observed in operating time or the overall rate of postoperative complications (4.1% vs. 3.2%; p = 0.731). SLC exhibited better cosmetic results in the short term. In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups.
Taking into account a follow-up rate of 68%, the early postoperative advantages of SLC in relation to cosmetic appearance and pain did not persist in the long term. In the present trial, there was no difference in incisional hernia rates between SLC and MLC, but the sample size is too small for a final conclusion regarding hernia rates.
German Registry of Clinical Trials DRKS00012447.
在过去的几年中，单切口腹腔镜胆囊切除术（SLC）已成为多孔腹腔镜胆囊切除术（MLC）的替代方法。SLC 在美容效果方面具有优势，术后疼痛似乎较低。SLC 和 MLC 的总体并发症相当。然而，缺乏随机试验的长期结果，特别是要回答切口疝发生率、长期美容影响和慢性疼痛的问题。
对 2009 年 12 月至 2011 年 6 月期间的 193 例患者进行了 SLC 与 MLC 的随机试验。主要终点是术后第一天的术后疼痛。次要终点是转化率、手术时间、术中术后发病率、技术可行性和住院时间。术后增加了长期随访。
98 例（50.8%）患者行 SLC，95 例（49.2%）患者行 MLC。术后第一天的疼痛在手术过程中没有差异（SLC 与 MLC，分别为 3.4±1.8 与 3.7±1.9；p=0.317）。手术时间或术后并发症的总体发生率无显著差异（4.1%比 3.2%；p=0.731）。SLC 在短期内具有更好的美容效果。在长期随访中，平均随访 70.4 个月后，两组之间的切口疝发生率、美容效果或切口疼痛均无差异。
考虑到随访率为 68%，SLC 在美容外观和疼痛方面的早期术后优势在长期内并未持续。在本试验中，SLC 和 MLC 之间的切口疝发生率没有差异，但疝发生率的最终结论样本量太小。
德国临床试验注册处 DRKS00012447。
