Abstract 117TiP
Background
Radical resection remains the cornerstone treatment for non-metastatic colorectal cancer (CRC). Conventional laparoscopic surgeries often involve assistants whose limited skills and experience may lead to inadvertent injuries and surgeon interference. Reduced-port laparoscopic surgery, with its simplified setup of two operation ports for the surgeon and one observation port for the assistant, allows for independent surgeon completion of the procedure. This approach potentially mitigates prolonged operation times and injuries due to inexperienced assistants. Additionally, reduced-port laparoscopy entails fewer incisions, translating to reduced postoperative pain, quicker recovery, and decreased resource utilization and medical expenses.
Trial design
This multicenter, open-label, randomized phase III trial with a parallel design is conducted in China. Patients are randomized (1:1) to either the reduced-port laparoscopic surgery group or the conventional laparoscopic surgery group using a computerized randomization management system. The reduced-port laparoscopic surgery group undergoes surgery with three ports, while the conventional laparoscopic surgery group undergoes surgery with five ports. This study represents the first prospective randomized controlled trial assessing the safety and efficacy of reduced-port laparoscopic surgery for resectable CRC. The study aims to evaluate perioperative complications, R0 resection rates, and 3-year disease-free and overall survival rates. Key inclusion criteria include preoperative clinical tumor stage I-III (cTxNxM0) CRC, histologically confirmed colorectal adenocarcinoma, and patient capacity to provide informed consent. Main exclusion criteria comprise a history of other malignant tumors, complications necessitating emergency surgery, non-resectable lymph node metastasis, high ASA grading, and/or elevated ECOG scores. A total of 500 patients are planned for enrollment, with 128 patients enrolled as of May 5th, 2024. The trial is registered with ClinicalTrials.gov (NCT05953662) and ongoing.
Clinical trial identification
NCT05953662.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.