Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps

Adenomatous Polyp of Large Intestine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368731
• Other study ID #: EMR-001-PEC
• Secondary ID: HREC2010/11/4.12
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2015

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: August 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyp of Large Intestine
• Adenomatous Polyps
• Colonic Polyps
• Polyps

Intervention

Procedure:
• Prophylactic use of coagulation therapy
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.

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of delayed bleeding		14 days