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Prophylactic and Endoscopic Clip Placement to Prevent Clinically Significant Post Wide Field Endoscopic Mucosal Resection Bleeding - a Randomised Controlled Trial.
Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions\>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Westmead Endoscopy Unit
Westmead, New South Wales, Australia
Start Date
October 1, 2014
Primary Completion Date
December 1, 2020
Completion Date
March 1, 2021
Last Updated
March 27, 2025
230
ACTUAL participants
Endoscopic Clip
DEVICE
Lead Sponsor
Professor Michael Bourke
NCT07089615
NCT02198729
NCT05012527
Data Source & Attribution
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