Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer The SIMPLE Multicenter Randomized Clinical Trial
Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer The SIMPLE Multicenter Randomized Clinical Trial
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DOI：
10.1097/sla.0000000000003882
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发表时间：
2021-02-01
影响因子：
9
通讯作者：
Kim, Jun Gi
中科院分区：
文献类型：
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作者：
Lee, Yoon Suk;Kim, Ji Hoon;Kim, Jun Gi
目的：比较单孔腹腔镜手术（SPLS）和多孔腹腔镜手术（MPLS）治疗结肠癌的短期围手术期结局。背景数据总结：尽管许多研究报告了与MPLS相比SPLS治疗结肠癌的短期和长期结果，但很少有随机对照试验的结果。方法：本研究为多中心、前瞻性、随机对照、非劣效性研究。于2011年8月至2017年6月在韩国的7个研究中心进行。共388例临床I、II或III期升结肠或乙状结肠腺癌成人（年龄19-85岁）入组并随机分组。主要终点为术后30天并发症发生率。次要终点是收集的淋巴结数量、切除边缘长度、术后疼痛和功能恢复时间（排便和饮食）。患者术后随访30天。结果：在388例患者中，359例（92.5%）完成了研究（SPLS，n = 179; MPLS，n = 180）。术后30天并发症发生率SPLS组为10.6%，MPLS组为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（4.6 cm vs 7.2 cm，P < 0.001），而标本提取部位的长度无差异（4.4 cm vs 4.6 cm，P = 0.249）。两组间所有次要终点和所有其他结局均无显著差异。结论：尽管在进行结肠癌切除术时，SPLS与MPLS相比没有明显的益处，但我们的数据表明，SPLS不劣于MPLS，并且在由经验丰富的外科医生进行时，可以被认为是选定患者的一种选择。
Objective: To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer. Summary Background Data: 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. Methods: 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. Results: 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. Conclusions: 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.