A prospective European trial comparing laparotomy, laparoscopy, robotic-assisted, and transanal total mesorectal excision procedures in high-risk patients with rectal cancer: The RESET trial

Abstract

To compare total mesorectal excision (TME) techniques combined with sphincter-sparing procedures in high-risk patients (HRPs). Background: TME is the standard treatment for rectal cancer, but it can be challenging in HRPs. The available surgical approaches must be compared, especially in HRPs. Methods: Prospective, observational, multicenter trial to compare laparotomy (OTME), laparoscopy (LTME), robotic-assisted surgery (RTME), and transanal surgery (TaTME) in HRPs. The composite primary outcome included circumferential radial margin (CRM) >= 1 mm, TME grade II-III, and absence of Clavien-Dindo grade III-IV complications. Three propensity score analyses were performed (LTME vs RTME, RTME vs TaTME, LTME vs TaTME). Results: A total of 1078 HRPs (75% of men, median body mass index of 27 kg/m2, 50% of tumors in the lower third of the rectum) underwent surgery. The RTME and TaTME groups included patients with more advanced and lower tumors and coloanal anastomosis (P