Department of General Surgery, Nanfang Hospital, Southern Medical University, 1838 North Guangzhou Avenue, Guangzhou, 510-515, China.
Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.
The objective of the study is to evaluate the short-term outcomes of single-incision plus one-port surgery (SILS + 1) compared with conventional laparoscopic surgery (CLS) for colonic cancer.
At present, single-incision laparoscopic colectomy remains technically challenging. The use of SILS + 1 as an alternative has gained increasing attention; however, its safety and efficacy remain controversial.
Between April 2014 and July 2016, 198 patients with clinical stage T1-4aN0-2 M0 rectosigmoid cancer were enrolled. The participants were randomly assigned to either SILS + 1 (n = 99) or CLS (n = 99). The morbidity and mortality within 30 days, operative and pathologic outcomes, postoperative recovery course, inflammation and immune responses, and pain intensity were compared.
There was no significant difference in overall complications between the two groups (17.2 vs. 16.3%, P = 1.000). The total operating time for the SILS + 1 group was significantly shorter (100.8 ± 30.4 vs. 116.6 ± 36.6, P = 0.002). Blood loss was significantly greater in the CLS group (20 vs. 50, P < 0.001). Thirteen patients (14%) in the CLS group required additional postoperative analgesics, which was significantly more than four patients in the SILS + 1 group. Notably, on postoperative day three, the visual analogue scale score of the CLS group was greater than that of the SILS + 1 group (1.3 ± 1.1 vs. 1.7 ± 1.3, P = 0.023). Tumor diameter, pathologic stage, length of the proximal and distal margins, and number of lymph nodes harvested were similar, other values were also similar between the two groups.
Our findings suggest that SILS + 1 might be safe and feasible for rectosigmoid cancer when performed by experienced surgeons. It offers minimal invasiveness without compromising oncologic treatment principles. Trial Registration This trial was registered on ClinicalTrials.gov (NCT02117557).
本研究旨在评估单切口加单端口手术（SILS+1）与传统腹腔镜手术（CLS）治疗结肠癌的短期疗效。
目前，单切口腹腔镜结肠切除术在技术上仍具有挑战性。SILS+1 的应用作为一种替代方法已引起越来越多的关注，但它的安全性和有效性仍存在争议。
2014 年 4 月至 2016 年 7 月，共纳入 198 例临床分期为 T1-4aN0-2M0 直肠乙状结肠癌患者。患者被随机分配至 SILS+1 组（n=99）或 CLS 组（n=99）。比较两组患者的 30 天内发病率和死亡率、手术和病理结果、术后恢复过程、炎症和免疫反应以及疼痛强度。
两组总体并发症发生率无显著差异（17.2%比 16.3%，P=1.000）。SILS+1 组的总手术时间明显更短（100.8±30.4 比 116.6±36.6，P=0.002）。CLS 组的出血量明显更多（20 比 50，P<0.001）。CLS 组有 13 例（14%）患者需要额外的术后镇痛，明显多于 SILS+1 组的 4 例。值得注意的是，术后第 3 天，CLS 组的视觉模拟评分（VAS）大于 SILS+1 组（1.3±1.1 比 1.7±1.3，P=0.023）。肿瘤直径、病理分期、近端和远端切缘长度以及淋巴结清扫数量在两组间相似，其他值也相似。
我们的研究结果表明，对于经验丰富的外科医生来说，SILS+1 治疗直肠乙状结肠癌可能是安全可行的。它提供了微创性，而不影响肿瘤治疗原则。
本试验在 ClinicalTrials.gov 注册（NCT02117557）。
