Transanal versus laparoscopic total mesorectal excision for low rectal cancer: A multicenter randomized phase III clinical trial (TaLaR trial) protocol.

Abstract

TPS3631 Background: Since 1982, Total Mesorectum Excision (TME) was regarded as a golden standard for radical resection of rectal cancer. Current evidences have proved that both open and laparoscopic TME could achieve the comparative oncological safety. However, for low rectal cancer, it remains a challenge to achieve complete TME with safe resections margin by the conventional transabdominal approach, especially in cases such as bulky mesorectum, enlarged prostate, narrow pelvic floor, etc. Transanal TME (TaTME) is a new approach for rectal cancer. Several retrospective studies have showed its advantage of providing better resection quality for low rectal cancer compared with transabdominal approach, but its long-term effect still needs to be explored. Methods: TaLaR trial is an open-label multicenter randomized controlled phase III trial with a non-inferiority design, aiming to compare the short and long term effect between TaTME and laparoscopic TME (lapTME) for low rectal cancer. Patients diagnosed with clinical stage no more than T3N0 or ycT3N2 rectal cancer, inferior border of the tumor from anal verge less than 7cm, are eligible for the present study. A total of 1114 patients (557 per group) will be randomized to either TaTME or lapTME. The primary end-points are 3-year disease-free survival (DFS) and 5-year overall survival (OS). The secondary endpoints include resection quality, postoperative morbidity and mortality, pelvic function and quality of life. Clinical trial information: NCT 02966483.