Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial
18 Years
N/A
Both
Adenomatous Polyp of Large Intestine
Trial Information
Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial
Delayed bleeding from the site of the resection remains one of the most common complications
following EMR, occurring in up to 12% of patients. The purpose of the study is to prevent
such bleeding with the use of a technique known as: "coagulation therapy." This therapy
involves using a small dose of heat energy that results in clotting(coagulation) of a blood
vessel. It is already used widely in the stomach and we intend using this on a lower
setting to blood vessels that are exposed after the resection.
Inclusion Criteria:
- Patients referred to Westmead Hospital Endoscopy unit for endoscopic removal of a
large sessile colonic polyp sized >20mm
- Age >18 years
- Able to give informed consent to involvement in trial
Exclusion Criteria:
- Pregnancy: currently pregnant or attempting to become pregnant
- Lactation: currently breastfeeding
- Taken clopidogrel within 7 days
- Taken warfarin within 5 days
- Had full therapeutic dose unfractionated heparin within 6 hours
- Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- Known clotting disorder
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Presence of delayed bleeding
Outcome Time Frame:
14 days
Safety Issue:
No
Principal Investigator
Michael J Bourke
Investigator Role:
Principal Investigator
Investigator Affiliation:
Westmead Hospital - Endoscopy Unit
Authority:
Australia: Human Research Ethics Committee
Study ID:
EMR-001-PEC
NCT ID:
NCT01368731
Start Date:
May 2011
Completion Date:
January 2015
Related Keywords:
- Adenomatous Polyp of Large Intestine
- Colonic Polyps
- Hemorrhage
- Polyps
- Adenomatous Polyps
Name | Location |
|---|
