Aspirin and the Risk of Bleeding After Colon Polypectomy
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Purpose
The purpose of this study is to determine if the use of aspirin prior to colonoscopy increases the risk of postpolypectomy 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 postpolypectomy bleeding.
| Condition | Intervention |
|---|---|
|
Colonoscopy Polypectomy |
Drug: Aspirin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) |
| Official Title: | Aspirin and the Risk of Bleeding After Colon Polypectomy, Multicenter, Randomized Controlled Trial |
- postpolypectomy bleeding rate [ Time Frame: bleeding after polypectomy within 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Aspirin group |
Drug: Aspirin
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,
|
| Experimental: Aspirin holding group |
Drug: Aspirin
Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,
|
Detailed Description:
Based on very limited evidences, ASGE recommended that endoscopic procedures may be performed on patients taking aspirin. However in a survey of ASGE members regarding their endoscopic practice, 81% would consider discontinuation of aspirin before colonoscopy and 66% would not perform snare polypectomy if patients had not discontinued aspirin. Although a large prospective randomized control trial would be the ideal way to address this issue theoretically, the investigators hypothesized that there are no differences of the postpolypectomy bleeding rate in patients whether continuous taking aspirin prior to polypectomy or not.
In this study, the patients are prospectively randomized into two groups; one is taking aspirin continuously and the other quit taking aspirin 7 days before polypectomy up to 3 days after polypectomy. Randomization is stratified by age which can affect postpolypectomy bleeding. Enrolled subjects include the patients who take low dose aspirin (75~160mg) for primary prevention of vascular disease and low risk for thromboembolism. Exclusions are as follow; patients taking anti-thrombotic agents, patients taking thienopyridines or other NSAID with aspirin, patients who have low a platelet count (<80,000/mm3) and/or prolongated PT/aPTT, patients who have chronic renal disease (creatinine>3mg/dl over 6 months), patients who have polyps over than 1 cm in size or thick pedicle over 1 cm, patients who have GI malignancies, patients who are over ASA classification class III. The expected enrolled patients number is 500 patients (250 in each group).
All cases of polypectomy are performed with identical methodology; resection after epinephrine mixture injection under blended or mixed current wave. The data includes patients information such as sex, age, body weight, BMI and vascular disease history such as hypertension, diabetes, ischemic heart disease, cerebrovascular disease, COPD, number of polyps, bleeding status(acute, early, delayed/minimal, moderate, sever), endoscopist (staff or fellow), bowel preparation status, polyp character (shape, location, pathology) and procedures for bleeding (clipping, APC, epinephrine injection, band ligation etc.).
All procedure will be performed with the endoscopist blinded to the patient status of whether the patient is taking aspirin continuously or not.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hyun Gun, Kim. M.D., Ph.D., Assistant professor, Soonchunhyang University Hospital |
| ClinicalTrials.gov Identifier: | NCT01465256 History of Changes |
| Other Study ID Numbers: | KASIDPOLYP |
| Study First Received: | November 1, 2011 |
| Last Updated: | November 3, 2011 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Soonchunhyang University Hospital:
|
Aspirin |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013