NCT01504425CompletedNot Applicable
An Observational Study of Difficult Colonic Polypectomies
Clinical Hospital Colentina1 site in 1 country91 target enrollmentStarted: December 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- complication rate
Study Overview
Brief Summary
The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •colonic polyps that are deemed difficult to resect by the endoscopist
Exclusion Criteria
- •patient refusal to participate in the trial
Outcomes
Primary Outcomes
complication rate
Time Frame: 30 days
the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure
Secondary Outcomes
No secondary outcomes reported
Investigators
dr. Theodor Alexandru Voiosu
MD
Clinical Hospital Colentina
Study Sites (1)
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