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Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision

NCT04091620 · Chinese University of Hong Kong · Updated 4 Oct 2019

What is being tested
Transanal Total Mesorectal Excision; Robotic Total Mesorectal Excision
For
Rectal Cancer
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 108 people. The full rules are on the registry page.
Where
China
When
Starts or started 1 Oct 2019, ends Oct 2022. Registered 17 Sept 2019.
Results
None posted yet.

In the researchers' words

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,…
ClinicalTrials.gov, NCT04091620

Sites

  • Prince of Wales Hospital, The Chinese University of Hong KongHong Kong, China