Transanal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer A Multicenter Randomized Clinical Trial Comparing Surgical Methods

What this Trial Is About

Researchers are investigating surgical options for mid and low rectal cancer, comparing transanal total mesorectal excision (TaTME) with conventional laparoscopic total mesorectal excision (LpTME). TaTME is a newer technique designed to improve access and potentially achieve better cancer removal with lower rates of involved margins and incomplete tissue removal. Although previous smaller studies have suggested its feasibility and benefits, this multicenter randomized clinical trial aims to provide stronger evidence on whether TaTME can deliver better surgery quality and similar long-term survival outcomes as laparoscopic surgery. Participants will be randomly assigned to receive either the TaTME procedure or the conventional laparoscopic surgery. Both groups will undergo cancer removal surgeries performed by trained surgeons. The study will carefully compare resection quality, including how completely the cancerous tissue is removed and whether the margins are free of cancer. The trial also monitors short-term surgical outcomes such as complications and mortality. During the study, participants will be regularly assessed for disease-free survival over three years and overall survival over five years. Pathological examinations of removed tissue will be conducted by expert pathologists. Researchers will also track local cancer recurrence, functional health results, and quality of life. The trial plans to enroll over a thousand patients and will use electronic systems for data collection and randomization. Safety and treatment effectiveness will be followed closely throughout the study period.

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer