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Brief Title: Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision
Official Title: Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision for Mid and Low Rectal Cancer: A Prospective Randomized Controlled Trial
Study ID: NCT04091620
Brief Summary: Background: Laparoscopic total mesorectal excision (TME) for rectal cancer is technically challenging because of the confined space within the pelvis. The robotic surgical system is recently introduced to overcome the limitations of laparoscopy in terms of visualization and maneuverability, but robotic surgery is expensive. Transanal total mesorectal excision (TaTME) is an emerging surgical approach that allows dissection of the most difficult part of the TME plane deep down in the pelvis using a less costly transanal platform. To date, no randomized controlled trial can be found in the literature comparing TaTME and robotic TME. Objectives: To compare the pathologic outcomes, functional outcomes, and costs between TaTME and robotic TME for mid or low rectal cancer. Design: Prospective, randomized, controlled, superiority trial. Subjects: One hundred and eight consecutive patients who are clinically diagnosed with cT1-3, N0-2, M0 rectal cancer located within 12 cm of the anal verge who do not require abdominoperineal resection will be recruited. Interventions: Patients will be randomly allocated to undergo either TaTME or robotic TME. Outcome measures: Primary outcome: composite pathologic endpoint (complete TME, clear circumferential and distal resection margins). Secondary outcomes: conversion rate, postoperative recovery, morbidity, health-related quality of life, urosexual function, and costs. Hypothesis: Results of the present study can provide evidence-based clarification of the efficacy and safety of TaTME for patients with mid and low rectal cancer. The results of this proposed project may have a significant impact on the future treatment strategy for mid and low rectal cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, , China
Name: Simon SM Ng, MD
Affiliation: Chinese University of Hong Kong
Role: PRINCIPAL_INVESTIGATOR