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Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial.
Surgical Endoscopy 2019 March
OBJECTIVE: 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.
BACKGROUND: 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.
METHODS AND PATIENTS: 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.
RESULTS: 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.
CONCLUSION: 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).
BACKGROUND: 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.
METHODS AND PATIENTS: 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.
RESULTS: 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.
CONCLUSION: 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).
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