Rectal Cancer Clinical Trial
Official title:
Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision for Mid and Low Rectal Cancer: A Prospective Randomized Controlled Trial
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.
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