Soft Coagulation for the Prevention of Adenoma Recurrence (SCAR)

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

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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