Status:
COMPLETED
A Pilot Randomized Trial of Polypectomy Techniques for 4-6 mm Colonic Polyps
Lead Sponsor:
Indiana University
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
Conditions:
Colon Polyps
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Complete polypectomy is one of the major factors for effectiveness of colonoscopy to prevent colon cancer. Given the prevalence of the 4-6 mm polyp, and the concern about interval cancers at polypecto...
Detailed Description
Colonoscopic polypectomy is one of the most commonly performed procedures in the United States. Despite the frequency with which polypectomy is performed, there is a remarkable absence of data regardi...
Eligibility Criteria
Inclusion
- Persons undergoing screening, surveillance, or diagnostic colonoscopy who are found to have 1 or more adenomatous colon polyps 4-6 mm in size with Paris morphology of types I or IIa in well-defined segments of the colon.
Exclusion
- Inability to provide informed consent
- Requirement for long-term anticoagulation or clopidogrel (Plavix)
- Known International normalized ratio (INR) ≥ 1.5
- Less than satisfactory colon preparation quality
- Inability to intubate the cecum or reach the surgical anastomosis in case of cecectomy
- Age greater than 75
- Inpatient status (acute lower GI bleeding, etc.)
- Comorbidity that precludes the need for surveillance
- Pregnancy
- Already included in the protocol
- Pre- solid organ transplantation
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT04666194
Start Date
September 1 2009
End Date
October 1 2019
Last Update
January 12 2021
Active Locations (3)
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1
Springmill endoscopy center
Carmel, Indiana, United States, 46290
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
3
Wishard Memorial Hospital/Eskenazi Health
Indianapolis, Indiana, United States, 46202