Post-resection Treatment of Large Colon Polyps
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 11/18/2018 |
| Start Date: | October 16, 2018 |
| End Date: | January 2020 |
| Contact: | Heather Broadley, MA |
| Email: | hbroadle@iu.edu |
| Phone: | 317-278-4554 |
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
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
(30 W, Effect 1) vs No Treatment of the perimeter of the EMR site.
resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC
(30 W, Effect 1) vs No Treatment of the perimeter of the EMR site.
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
approximately 6 months from the initial procedure. The investigators will measure the rate of
recurrence by endoscopic visualization of the EMR site at the 6 month follow-up using
endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the
scars.
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
approximately 6 months from the initial procedure. The investigators will measure the rate of
recurrence by endoscopic visualization of the EMR site at the 6 month follow-up using
endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the
scars.
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
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Dougls K Rex
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