Status:
UNKNOWN
Transanal Total Mesorectal Excision Versus Robotic Total Mesorectal Excision
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 introduce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04091620
Start Date
October 1 2019
End Date
October 1 2022
Last Update
October 4 2019
Active Locations (1)
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1
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, China