Back to resultsProphylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps
Primary Purpose
Adenomatous Polyp of Large Intestine
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Prophylactic use of coagulation therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Adenomatous Polyp of Large Intestine
Eligibility Criteria
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
Sites / Locations
- Westmead Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
nil prophylactic coagulation
Prophylactic coagulation
Arm Description
Outcomes
Primary Outcome Measures
Presence of delayed bleeding
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01368731
Brief Title
Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps
Official Title
Prophylactic Endoscopic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multi-centre, Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyp of Large Intestine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
328 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nil prophylactic coagulation
Arm Type
No Intervention
Arm Title
Prophylactic coagulation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Prophylactic use of coagulation therapy
Other Intervention Name(s)
Heat probe, Soft coagulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of delayed bleeding
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bourke
Organizational Affiliation
Westmead Hospital - Endoscopy Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25151254
Citation
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.
Results Reference
derived
Learn more about this trial
Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps
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