Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps
Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial
2 other identifiers
interventional
328
1 country
1
Brief Summary
The hypothesis of this study is that prophylactic coagulation therapy with coagulation forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection (EMR) will reduce the rate of delayed bleeding when compared with current established standard EMR technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 6, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMarch 27, 2025
March 1, 2025
2.7 years
June 6, 2011
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of delayed bleeding
14 days
Study Arms (2)
nil prophylactic coagulation
NO INTERVENTIONProphylactic coagulation
ACTIVE COMPARATORInterventions
The procedure is completed as per usual, and if the patient has been randomized to the intervention group the appropriate coagulation therapy will be applied immediately after standard EMR to visible vessels within the mucosal resection area.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Related Publications (1)
Bahin FF, Naidoo M, Williams SJ, Hourigan LF, Ormonde DG, Raftopoulos SC, Holt BA, Sonson R, Bourke MJ. Prophylactic endoscopic coagulation to prevent bleeding after wide-field endoscopic mucosal resection of large sessile colon polyps. Clin Gastroenterol Hepatol. 2015 Apr;13(4):724-30.e1-2. doi: 10.1016/j.cgh.2014.07.063. Epub 2014 Aug 20.
PMID: 25151254DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Bourke
Westmead Hospital - Endoscopy Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr Michael Bourke
Study Record Dates
First Submitted
June 6, 2011
First Posted
June 8, 2011
Study Start
May 1, 2011
Primary Completion
January 1, 2014
Study Completion
August 1, 2015
Last Updated
March 27, 2025
Record last verified: 2025-03