Safety and efficacy of reduced-port laparoscopic surgery for patients with colon and upper rectal cancer.

Abstract

LBA3555 Background: Radical laparoscopic resection is the mainstay of treatments for non-metastatic colorectal cancer (CRC). Reduced-port laparoscopic surgery (RPLS) has emerged with the concept of more minimal invasion on the basis of conventional laparoscopic surgery (CLS). RPLS has only 3 or 4 ports for surgeon and observer, which might increase the difficulty of the operation. The efficacy and safety of RPLS for CRC remains unclear. This study aims to evaluate the curative effect and safety of RPLS versus CLS for resectable CRC, which is registered with ClinicalTrials.gov (NCT05953662). Methods: From July 2023 to December 2024, a total of 500 patients with CRC received surgical treatment in the Sixth Affiliated Hospital of Sun Yat-sen University, Nanfang Hospital of Southern Medical University and Ruijin Hospital of Shanghai Jiao Tong University School of Medicine were enrolled in this prospective cohort study. The primary outcome measure is 1 year disease free survival (DFS). The secondary outcome measures are total operation time, intraoperative blood loss, postoperative hospital stays, complication rate, mortality, 3 years DFS and OS. Patients were randomized divided into RPLS group (n=250) and CLS group (n=250). The study has completed recruitment. Results: There were no significant differences of the clinical characteristics between the two groups. The RPLS group had significantly less intraoperative blood loss (26.23±22.33 ml vs 50.72±80.10 ml, P<0.001 ). The total operation time was also shorter for the RPLS group (147.89±52.40 min vs 189.77±67.79 min, P<0.001 ). The postoperative hospital stay was shorter for the RPLS group (7.63±4.45 days vs 8.22±3.61 days, P<0.001 ). Regarding postoperative complications, the RPLS group is comparable with CLS group in a total of grade I/II/III complication rate (6% vs 3.2%, P=0.154 ). Grade III complications were few in both groups, presenting in 0.4% of the RPLS group and 0.8% of the CLS group. The pTNM stage distribution was similar between the groups, with no significant differences ( P=0.59 ). The mean number of harvested lymph nodes was similar (22.25±13.72 vs 23.55±18.22, P=0.413 ), as well as the mean number of positive lymph nodes (1.04±2.54 vs 0.93±2.23, P=0.556 ). All of the participants were received a radical resection (R0 resection) with negative margin and circumferential resection margin. There was no mortality in 30 days postoperative. With a median follow-up of 10 months, 2 cases experienced metastasis in the RPLS group and 4 cases in the CLS group experienced postoperative recurrence and metastasis. Conclusion: RPLS demonstrated non-inferiority in surgical safety compared to CLS, with significantly less intraoperative blood loss, shorter operation time. Additionally, RPLS showed superior postoperative recovery, with a shorter hospital stay. We need a long-term follow-up to validate the oncology safety of the reduced-port approach. Clinical trial information: NCT05953662 .