Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision

NCT04091620 | Unknown DMC

• 1 other identifier: CREC 2019.072
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection

  Achieving a composite pathologic endpoint or a successful resection is defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) clear circumferential resection margin (\>1 mm), and (3) clear distal resection margin (\> 1mm).

  Up to 1 month

Secondary Outcomes (14)

• Rate of conversion

  Up to 1 month

• Time to defecation

  Up to 1 month

• Time to resume full solid diet

  Up to 1 month

• Time to walk independently

  Up to 1 month

• Length of hospital stay

  Up to 1 month

Study Arms (2)

Transanal Total Mesorectal Excision

EXPERIMENTAL

For transanal total mesorectal excision, a two team approach will be adopted. One surgical team will be performing the abdominal phase dissection using standard laparoscopic approach, while the other will be simultaneously performing the transanal dissection and total mesorectal excision in a 'down-to-up' fashion using laparoscopic instruments.

Procedure: Transanal Total Mesorectal Excision

Robotic Total Mesorectal Excision

ACTIVE COMPARATOR

For robotic total mesorectal excision, a fully robotic approach will be adopted. Left-sided colonic mobilization, division of lymphovascular pedicle, and 'top-to-down' total mesorectal excision will be performed using the robotic platform.

Procedure: Robotic Total Mesorectal Excision

Interventions

Transanal Total Mesorectal Excision PROCEDURE

As above

Transanal Total Mesorectal Excision

Robotic Total Mesorectal Excision PROCEDURE

As above

Robotic Total Mesorectal Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients who are diagnosed with mid or low rectal adenocarcinoma, of which the lowest margin of the tumor is located at or within 12 cm of the anal verge as determined by rigid sigmoidoscopy
• Those with clinically diagnosed cT1-3, N0-2, M0 disease based on preoperative staging with pelvic magnetic resonance imaging, computed tomography, and/or positron emission tomography
• Age of patients greater than or equal to 18 years
• Those with American Society of Anesthesiologists (ASA) grading I-III,
• Informed consent available

You may not qualify if:

• Patients with locally advanced cancer not amenable to curative surgery (e.g. involved mesorectal fascia on pelvic magnetic imaging despite neoadjuvant chemoradiotherapy)
• Those with locally advanced T4 cancer requiring en bloc multivisceral resection
• Those with very low rectal tumor requiring abdominoperineal resection
• Those with synchronous colorectal tumors requiring multisegment resection
• Those undergoing emergency surgery
• Those with previous history of abdominal surgery precluding the robotic or laparoscopic approach;
• Those with severe cardiopulmonary disease rendering pneumoperitoneum hazardous
• Those with psychiatric disease
• Those who are pregnant

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Simon SM Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon SM Ng, MD

CONTACT

+852-35051495; simonng@surgery.cuhk.edu.hk

Tony WC Mak, MD

CONTACT

+852-35051495; tonymak@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 17, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)