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Completed

NCT Number: NCT01368731

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

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.

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Key information

Conditions

Adenomatous Polyp of Large Intestine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic use of coagulation therapy

Procedure

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.

Other names: Heat probe, Soft coagulation

Primary outcomes

  1. Presence of delayed bleeding

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 8, 2011
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.