Abstract 121TiP
Background
Lower rectal cancer (LRC), defined as tumors located ≤ 3cm from the dentate line, poses challenges in selecting optimal surgical approaches for anal preservation while ensuring oncological outcomes. Previous studies have shown comparable disease-free and overall survival rates between Parks' and Bacon's operations. However, evidence from large-scale randomized controlled trials directly comparing their effects on postoperative anal function, quality of life, complications, and overall survival in LRC patients is lacking.
Trial design
This prospective, multicentric, randomized controlled trial conducted in China aims to address this gap in knowledge. LRC patients meeting inclusion criteria are randomly assigned in a 1:1 ratio to either the Parks’ operation group or the Bacon’s operation group using a computerized randomization management system. Parks’ operation involves colon anal anastomosis, while Bacon’s operation involves colon anal pull-out anastomosis. Postoperative anal function is assessed using rectoanal manometry and the Low Anterior Resection Syndrome (LARS) score at 3 months, 6 months, and 1year post-surgery. Quality of life scores and the incidence of postoperative anastomotic complications are also evaluated. Key inclusion criteria include pathological confirmation of LRC with ≤ 3cm distance from the tumor to the dentate line by MRI, suitability for anal preservation surgery discussed by a multidisciplinary team, and patient ability to provide informed consent. Main exclusion criteria encompass history of other malignancies, emergent complications requiring immediate surgery, unresectable tumor extension, high ASA grading, and/or elevated ECOG scores. The study plans to enroll 265 patients, with 8 patients enrolled as of May 5th, 2024. Registration with ClinicalTrials.gov (NCT05943444) has been completed.
Clinical trial identification
NCT05943444.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.