This trial is active, not recruiting.

Condition adenomatous polyp of large intestine
Treatment prophylactic use of coagulation therapy
Sponsor Professor Michael Bourke
Start date May 2011
End date January 2014
Trial size 328 participants
Trial identifier NCT01368731, EMR-001-PEC, HREC2010/11/4.12(3155) AU RED


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
(No Intervention)
(Active Comparator)
prophylactic use of coagulation therapy Heat probe
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 Outcomes

Presence of delayed bleeding
time frame: 14 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Michael J Bourke
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Western Sydney Local Health District.