The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Continuing or Discontinuing on Aspirin: a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of
colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under
hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist
consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1).
The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo
and prepared for the study (Visit 2). Patient will be under the care of a physician after
polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control
visit, during which the physician will take back patient diary and pack treatment (Visit 3).
30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will
be monitored by looking at the end points.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Clinically significant bleeding after colorectal polypectomy
Clinically significant bleeding after polypectomy - any extravasation of blood from the polypectomy site [immediate (30s after polypectomy), early (to 24ha after polypectomy) or delayed (24ha to 30 days after polypectomy)], with clinical and/or endoscopic and/or laboratory (Hb decline by more than 3 g%)symptoms and would require endoscopic intervention and/or surgical and/or blood transfusions;
within 30 days after polypectomy
Regula Jaroslaw, MD PhD
The Medical Centre for Postgraduate Education, and Center of Oncology Institute, Warsaw, Poland
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products