NCT03413930

Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer

Single-center Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Total Mesorectal Excision in Rectal Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.

Detailed description

Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Transanal total mesorectal excision	Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
PROCEDURE	Laparoscopic total mesorectal excision	Patients undergo Laparoscopic total mesorectal excision.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-03-01
• Completion: 2026-03-01
• First posted: 2018-01-29
• Last updated: 2020-02-17

Locations

1 site across 1 country: China