A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct… (NCT05169242) | Clinical Trial Compass
RecruitingNot Applicable
A Trial on Prophylactic Clipping to Prevent Post-polypectomy Bleeding After Colonoscopy in Direct Oral Anticoagulant Users
Hong Kong584 participantsStarted 2021-12-15
Plain-language summary
The investigators hypothesize that prophylactic clipping after colonoscopic polypectomy can reduce risk of delayed PPB among DOAC users. The investigators also hypothesize that pre-endoscopy drug level can predict the risk of hemorrhagic complications after the procedure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* They are active users of any DOAC
* They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or past gastrointestinal bleeding
* Aged 18 years old or above;
* Written informed consent obtained.
Exclusion Criteria:
* Absolute contraindications to colonoscopy
* Any medical conditions precluding interruption of DOAC for procedure
* Any medical conditions requiring concomitant uninterrupted dual antiplatelet drugs (single antiplatelet drug users will not be excluded)
* Active gastrointestinal bleeding
* Clinically significant bleeding tendency (decompensated cirrhosis or severe thrombocytopenia)
* Severe renal impairment (defined as creatinine clearance \< 15 ml/min)
* Pregnancy or lactation;
* Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
* Unable to obtain informed consent