Clinical trial NCT04091620: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence rate of achieving a composite of pathologic endpoint indicating adequate surgical resection
timeFrame: Up to 1 month
Secondary outcomes:
measure: Rate of conversion
timeFrame: Up to 1 month
measure: Time to defecation
timeFrame: Up to 1 month
measure: Time to resume full solid diet
timeFrame: Up to 1 month
measure: Time to walk independently
timeFrame: Up to 1 month
measure: Length of hospital stay
timeFrame: Up to 1 month
measure: Pain scores on visual analog scale
timeFrame: Up to 1 month
measure: Morbidity within 30 days
timeFrame: Up to 1 month
measure: Urinary function at 3, 6, 9, and 12 months after surgery, measured by the International Prostate Symptom Score (IPSS)
timeFrame: Up to 12 months
measure: Male sexual function at 3, 6, 9, and 12 months after surgery, measured by the International Index of Erectile Dysfunction - 5 (IIEF-5 questionnaire)
timeFrame: Up to 12 months
measure: Anal continence at 3, 6, 9, 12 months after surgery, measured by the Cleveland Clinic Incontinence Score (Wexner's Score)
timeFrame: Up to 12 months
measure: Quality of life scores measured by Short Form 36 (SF-36) Health Survey at 3, 6, 9, 12 months after surgery
timeFrame: Up to 12 months
measure: Quality of life scores measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaires at 3, 6, 9, 12 months after surgery
timeFrame: Up to 12 months
measure: Quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaires at 3, 6, 9, 12 months after surgery
timeFrame: Up to 12 months
measure: Direct/indirect medical costs and out-of-hospital economic costs
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: