Status:
COMPLETED
Endoscopic Visualisation of Anastomosis in Colorectal Cancer Surgery
Lead Sponsor:
University of Plymouth
Conditions:
Rectal Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A randomised feasibility study into the use of endoscopic visualisation of rectal anastomosis vs. current practice and the effect on anastomotic leak rates in patients undergoing rectal surgery for bo...
Detailed Description
Anastomotic leak is one of the biggest challenges in colorectal surgery with little still known about what causes a leak. An anastomotic leak is defined as a defect of the intestinal wall at the anast...
Eligibility Criteria
Inclusion
- Over 18 years of age
- Undergoing colorectal resection involving the rectum
- Able to give informed consent to participate in trial
- American Society of Anesthesiologists (ASA) grade ≤ 3
Exclusion
- Patients not undergoing colo-rectal/anal anastomosis e.g. abdominoperineal excision of rectum (APER), Hartmann's procedure.
- Patients undergoing synchronous colonic resections.
- Locally advanced rectal cancer requiring extended or multi-visceral excision.
- Recurrent rectal cancer
- Coexistent colorectal pathology e.g. synchronous cancers, inflammatory bowel disease.
- Previous pelvic radiotherapy for pathology unrelated to diagnosis with rectal cancer e.g. treatment for prostate cancer
- Patients who are pregnant
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04738240
Start Date
March 11 2019
End Date
April 25 2020
Last Update
February 4 2021
Active Locations (1)
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1
University Hospitals Plymouth
Plymouth, Devon, United Kingdom, EX1 2TE