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

P

Professor Michael Bourke

Status

Completed

Conditions

Adenomatous Polyp of Large Intestine

Treatments

Procedure: Prophylactic use of coagulation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01368731
EMR-001-PEC
HREC2010/11/4.12(3155) AU RED (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

328 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

328 participants in 2 patient groups

nil prophylactic coagulation
No Intervention group
Prophylactic coagulation
Active Comparator group
Treatment:
Procedure: Prophylactic use of coagulation therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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