Soft Coagulation for the Prevention of Adenoma Recurrence (SCAR)

P

Professor Michael Bourke

Status

Completed

Conditions

Colonic Adenomas

Treatments

Other: Snare Tip Soft Coagulation
Other: No Snare Tip Soft Coagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01789749
HREC/12/WMEAD/139
HREC2012/5/4.6 (3512) (Other Identifier)

Details and patient eligibility

About

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.

Enrollment

455 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Referred for removal of a colonic polyp >= 20mm in size
  • Able to give informed consent to involvement in trial

Exclusion criteria

  • Younger than 18 years of age
  • Highly dependant on medical care
  • Women who are pregnant or may be pregnant.
  • 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
  • Previous attempt at EMR of the polyp referred for resection
  • Polyp located at the ileo-caecal valve, appendiceal orifice
  • Fully circumferential polyp
  • Incomplete snare resection of the polyp

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

455 participants in 2 patient groups

No Coagulation Arm
Active Comparator group
Description:
Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Treatment:
Other: No Snare Tip Soft Coagulation
Coagulation Arm
Experimental group
Description:
Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Treatment:
Other: Snare Tip Soft Coagulation

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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