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A randomized controlled, multicenter trial investigating management of Direct Oral anticoagulant (DOACs) for colorectal polypectomy

Phase 3
Recruiting
Conditions
Colorectal polyp
Registration Number
JPRN-UMIN000039418
Lead Sponsor
Osaka International Cancer Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
400
Inclusion Criteria

Not provided

Exclusion Criteria

1 Person who has registered in this test. 2 Inflammatory bowel disease, colon polyposis. 3 Patients are receiving systemic steroids, antiplatelet drugs, and multiple anticoagulants continuously. (However, patients who can respond to antiplatelet drugs according to the guidelines of the Japanese Endoscopy Society can be registered.) 4 Blood coagulation dysfunction disease. 5 Women who are pregnant, may become pregnant, or are breastfeeding. 6 Patients with psychosis or psychiatric symptoms seem to have difficulty participating in the study. 7 Active bacterial and fungal infection (has a fever of 38.5 degrees or higher and is associated with bacterial infectivity by diagnostic imaging or bacteriological examination). 8 Uncontrolled hypertension. 9 Respiratory disease requiring continuous oxygen administration. 10 Dialysis. 11 Others who are judged inappropriate by the attending physician (eg, the prescribing physician of the anticoagulant determined that participation in this study was dangerous).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of severe bleeding (uncontrolled intraoperative and postoperative bleeding) associated with polypectomy.
Secondary Outcome Measures
NameTimeMethod
Rate of postoperative bleeding without emergency endoscopic hemostasis after polypectomy Rate of bleeding requiring blood cessation immediately after polypectomy DOAC dose intensity ( dose intensity) The rate of bleeding in patients who underwent only Cold Snare / Forceps Polypectomy The rate of bleeding by the type of DOAC, the rate of adverse events (the rate of thromboembolism, Incidence).
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