Single-incision laparoscopic surgery vs conventional laparoscopic surgery for colorectal cancer: Short-term outcomes of a multi-center, randomized, controlled trial.

Abstract

3589 Background: Single-incision laparoscopic surgery (SILS) is increasingly being embraced in the medical community due to its potential to offer less-invasiveness and quick recovery. This multi-center randomized controlled trial compared the short-term and long-term outcomes of single-incision laparoscopic surgery (SILS) with conventional laparoscopic surgery (CLS) for colorectal cancer, which might be the first of its kind that involved both colon and rectal cancer. Study recruitment has completed, and the follow-up is ongoing. Here we report the short-term outcomes of this trial. Methods: The trial was conducted across 11 hospitals in 6 provinces of China. Participants included patients with histologically confirmed colorectal carcinoma that situated above the peritoneal reflection, clinically staged as I-III. Patients were randomly assigned in a 1:1 ratio to SILS or CLS group. Comprehensive perioperative data were meticulously gathered, and follow-up assessments were scheduled postoperatively. The primary endpoint was 3-year disease-free survival (DFS), secondary endpoints included overall survival (OS), oncological efficacy, and postoperative outcomes. Results: Between May 2021 and April 2023, a total of 712 patients were randomly assigned to either the Single-incision Laparoscopic Surgery (SILS) group (n = 354) or the Conventional Laparoscopic Surgery (CLS) group (n = 358). The distribution of surgical procedures included 162 (22.8%) right hemicolectomies, 326 (45.8%) left hemicolectomies, and 224 (31.4%) proctectomies. The pathological TNM stages I, II, and III of the mITT population were 10.7%, 36.9%, and 52.4%, respectively. In the SILS group, 92.9% (n = 329) of the cases were completed entirely with a single incision. An additional trocar was used to assist the surgical procedure in 5.6% (n = 20) of the cases, and 0.8% (n = 3) were converted to conventional laparoscopic surgery. Two patients in the SILS group required conversion to open surgery, compared to 10 patients in the CLS group. The incidence of postoperative complications and oncological efficacy were statistically equivalent between the two groups. Moreover, patients in the SILS group reported significantly less postoperative pain (p = 0.02). There were no significant differences in short-term overall survival (OS) and disease-free survival (DFS) between the two arms. Conclusions: Single-incision laparoscopic surgery (SILS) for colorectal cancer has demonstrated with feasibility, safety, and efficacy. The less painful postoperative experience was aligned with the principles of Enhanced Recovery After Surgery (ERAS). This surgical approach extended the concept of minimally invasiveness and represents a logical progression towards Natural Orifice Transluminal Endoscopic Surgery (NOTES) or single-incision robotic surgery. Clinical trial information: NCT04527861 .