Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Recurrence
- Sponsor
- Indiana University
- Enrollment
- 384
- Locations
- 10
- Primary Endpoint
- Types of Recurrences
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.
Detailed Description
Data regarding polyp morphology, location \& shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications. All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.
Investigators
Douglas K. Rex
Principal Investigator
Indiana University
Eligibility Criteria
Inclusion Criteria
- •25 years and older
- •Ability to provide informed consent
- •Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Exclusion Criteria
- •Pedunculated lesions
- •Inflammatory bowel disease
- •Inability to provide informed consent
- •Lesions less than 15mm in largest dimension
Outcomes
Primary Outcomes
Types of Recurrences
Time Frame: 1 day
Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.
Recurrence
Time Frame: 1 day
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Secondary Outcomes
- Time(1 day)
- Complications(1 day)