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

This study is currently recruiting participants.
Verified June 2013 by South West Sydney Local Health District
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01368731
First received: June 6, 2011
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

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 (Subject)
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:

U.S. FDA Resources

Further study details as provided by South West Sydney Local Health District:

Primary Outcome Measures:
  • Presence of delayed bleeding [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 328
Study Start Date: May 2011
Estimated Study Completion Date: January 2015
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368731

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Bourke     98459779     westmeadendoscopyresearch@gmail.com    
Contact: Rebecca Sonson     0298459779     bec2153@gmail.com    
Principal Investigator: Michael Bourke            
Sub-Investigator: Stephen Williams            
Sub-Investigator: Mahendra Naidoo            
Sponsors and Collaborators
South West Sydney Local Health District
Investigators
Principal Investigator: Michael J Bourke Westmead Hospital - Endoscopy Unit
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, Dr Michael Bourke, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01368731     History of Changes
Other Study ID Numbers: EMR-001-PEC, HREC2010/11/4.12(3155) AU RED
Study First Received: June 6, 2011
Last Updated: June 12, 2013
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Colonic Polyps
Hemorrhage
Polyps
Adenomatous Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
 Pathologic Processes
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013