Department of Surgery, Seoul St. Mary Hospital, College of Medicine, The Catholic University Hospital, Seoul, Korea.
Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Incheon, Korea.
Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.
To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer.
Although many studies reported short- and long-term outcomes of SPLS for colon cancer compared with MPLS, few have reported results of randomized controlled trials.
This was a multicenter, prospective, randomized controlled trial with a noninferiority design. It was conducted between August 2011 and June 2017 at 7 sites in Korea. A total of 388 adults (aged 19-85 yrs) with clinical stage I, II, or III adenocarcinoma of the ascending or sigmoid colon were enrolled and randomized. The primary endpoint was 30-day postoperative complication rates. Secondary endpoints were the number of harvested lymph nodes, length of the resection margin, postoperative pain, and time to functional recovery (bowel movement and diet). Patients were followed for 30 days after surgery.
Among 388 patients, 359 (92.5%) completed the study (SPLS, n = 179; MPLS, n = 180). The 30-day postoperative complication rate was 10.6% in the SPLS group and 13.9% in the MPLS group (95% confidence interval, -10.05 to 3.05 percentage points; P < 0.0001). Total incision length was shorter in the SPLS group than in the MPLS group (4.6 cm vs 7.2 cm, P < 0.001), whereas the length of the specimen extraction site did not differ (4.4 cm vs 4.6 cm, P = 0.249). There were no significant differences between groups for all secondary endpoints and all other outcomes.
Even though there was no obvious benefit to SPLS over MPLS when performing colectomy for cancer, our data suggest that SPLS is noninferior to MPLS and can be considered an option in selected patients, when performed by experienced surgeons.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.
比较单孔腹腔镜手术（SPLS）与多孔腹腔镜手术（MPLS）治疗结肠癌的短期围手术期结局。
虽然许多研究报道了 SPLS 治疗结肠癌的短期和长期结果与 MPLS 相比，但很少有研究报告随机对照试验的结果。
这是一项多中心、前瞻性、随机对照非劣效性试验。该试验于 2011 年 8 月至 2017 年 6 月在韩国的 7 个地点进行。共纳入 388 名年龄在 19-85 岁之间、临床分期为 I、II 或 III 期升结肠癌或乙状结肠癌的成年患者，并进行了随机分组。主要终点为 30 天术后并发症发生率。次要终点为淋巴结清扫数目、切缘长度、术后疼痛和功能恢复时间（排便和饮食）。患者在手术后随访 30 天。
在 388 名患者中，有 359 名（92.5%）完成了研究（SPLS 组 179 名，MPLS 组 180 名）。SPLS 组和 MPLS 组的 30 天术后并发症发生率分别为 10.6%和 13.9%（95%置信区间，-10.05 至 3.05 个百分点；P<0.0001）。SPLS 组的总切口长度短于 MPLS 组（4.6cm 比 7.2cm，P<0.001），但标本取出部位的长度无差异（4.4cm 比 4.6cm，P=0.249）。两组间所有次要终点和其他所有结局均无显著差异。
即使在为癌症患者进行结肠切除术时，SPLS 并没有明显优于 MPLS，但我们的数据表明，当由经验丰富的外科医生进行操作时，SPLS 不劣于 MPLS，可以作为一种选择方案考虑用于某些特定患者。
ClinicalTrials.gov 标识符：NCT01480128。
