Yoon Suk Lee1, Ji Hoon Kim2, Hyung Jin Kim3, Sang Chul Lee4, Byung Mo Kang5, Chang Woo Kim6, Sang Woo Lim7, Suk-Hwan Lee6, Jun Gi Kim1. 1. Department of Surgery, Seoul St. Mary Hospital, College of Medicine, The Catholic University Hospital, Seoul, Korea. 2. Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Incheon, Korea. 3. Department of Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Seoul, Korea. 4. Department of Surgery, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University Hospital, Daejeon, Korea. 5. Department of Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea. 6. Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea. 7. Department of Surgery, Hallym Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea.
Abstract
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 stageI, 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.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.
RCT Entities:
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.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.