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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District Identifier:
First received: June 6, 2011
Last updated: December 15, 2015
Last verified: December 2015
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.

Condition Intervention
Adenomatous Polyp of Large Intestine
Procedure: Prophylactic use of coagulation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

Further study details as provided by Professor Michael Bourke, Western Sydney Local Health District:

Primary Outcome Measures:
  • Presence of delayed bleeding [ Time Frame: 14 days ]

Estimated Enrollment: 328
Study Start Date: May 2011
Estimated Study Completion Date: January 2020
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: nil prophylactic coagulation
Active Comparator: Prophylactic coagulation 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.
Other Names:
  • Heat probe
  • Soft coagulation

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01368731

Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
Professor Michael Bourke
Principal Investigator: Michael J Bourke Westmead Hospital - Endoscopy Unit
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District Identifier: NCT01368731     History of Changes
Other Study ID Numbers: EMR-001-PEC
HREC2010/11/4.12(3155) AU RED ( Other Identifier: HREC Office )
Study First Received: June 6, 2011
Last Updated: December 15, 2015

Additional relevant MeSH terms:
Adenomatous Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps processed this record on May 25, 2017