Bleeding Complication During Colon Polypectomy Clinical Trial
Official title:
Postpolypectomy Bleeding in Patients Undergoing Colonoscopy on Antiplatelet Therapy. - Multicenter, Prospective Observational Study -
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of post polypectomy bleeding. The primary end point is comparison of bleeding rates after polypectomy of a continuous aspirin group and temporally aspirin-quit group. The secondary end point is analysis of risk factors which affect early or delayed post polypectomy bleeding.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - The patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism. Exclusion Criteria: - The patients who taking anti-thrombotic agents, - The patients who taking thienopyridines or other NSAID with aspirin, - The patients who have low platelet count(<80,000/mm3) and prolongated PT/aPTT in laboratory test, - The patients who have chronic renal disease (creatinine>3mg/dl over 6 months), - The patients who have polyps over than 1 cm in size or thick pedicle over 1 cm, - The patients who have GI malignancies,the patients who are over ASA classification class III. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soonchunhyang univerisity hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Soonchunhyang University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postpolypectomy bleeding rate | bleeding after polypectomy within 30 days | Yes |