Polyp, Colorectal
Conditions
Keywords
Endoscopic Mucosal Resection (EMR), Tranexamic Acid, Colonoscopy
Brief summary
Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. There currently is no standard of care to prevent bleeding after polypectomy. Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding. Although this medication is used extensively for other purposes, it has not been studied before to prevent post-polypectomy bleeding. This pilot study will examine factors involved in the feasibility of conducting a large-scale randomized controlled trial (RCT). This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB.
Detailed description
Colorectal cancer is the second most common cancer in Canada. Colonoscopy and removal of precancerous polyps (polypectomy) reduces the incidence and mortality associated with colorectal cancer. However, polypectomy is associated with adverse events. Post-polypectomy bleeding has a significant impact on the life of the patient as it can require hospitalization, transfusions, repeat colonoscopy and rarely death. It is also a substantial cost to the health care system. Post-polypectomy delayed bleeding (PPDB) can occur up to a month following the procedure but is typically seen within the first week. Risk factors include the size of the polyp, antithrombotic or anticoagulation use, age, major comorbidities and proximal colon polyps. The incidence of bleeding after removal of large polyps is estimated to be around 2.6%-9.7%. There currently is no standard of care to prevent bleeding after polypectomy. Tranexamic acid reduces fibrinolysis by slowing down the conversion of plasminogen to plasmin which may prevent bleeding. This pilot study will examine factors involved in the feasibility of conducting a large-scale RCT. This pilot study will include 25 consecutive patients who are treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent PPDB.
Interventions
Intra-procedurally, participants will receive 1 gram of intravenous tranexamic acid immediately following the polypectomy. Participants will also take oral tranexamic acid tablets (three times per day) at home for the five days following the procedure.
Sponsors
Queen's University
Lawrence Charles Hookey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
25 consecutive patients treated with tranexamic acid after endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (LNPCP's) to prevent post-polypectomy delayed bleeding (PPDB).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged over 18 who have non-pedunculated colorectal polyps, 2. Polyps ≥2cm, 3. Polyps removed by endoscopic mucosal resection (EMR), 4. Agree to be followed up by phone, 5. Ability to read and understand the English language.
Exclusion criteria
1. Patients who have inflammatory bowel disease, 2. Diagnosed bleeding disorder, 3. Ulcerated morphology of polyps or those with proven invasive cancer, 4. Patients with a history of or are at higher risk of thromboembolic events (atrial fibrillation on anticoagulation, history of stroke, transient ischemic attack (TIA), pulmonary embolism, deep vein thrombosis, hypercoagulable state, oral contraceptive pill (OCP) or hormone replacement therapy use, mechanical heart valve on anticoagulation, myocardial infarction in the last twelve months, retinal vein or retinal artery occlusion), 5. Unable to provide follow up, 6. Unable to provide consent, 7. Pregnancy, 8. Patients undergoing endoscopic submucosal dissection (ESD), 9. Seizure disorder, 10. Ureteral obstruction within past 6 months, 11. Subarachnoid hemorrhage within past 6 months, 12. A diagnosed acquired defective colour vision disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment frequency | Through study completion, an average of 6 months | How many participants are enrolled each week |
| Study drug compliance rates | Through study completion, an average of 6 months | Number of participants that receive the intravenous tranexamic acid within 2 hours of polyp removal and the number of participants that receive every scheduled dose of the tranexamic acid at home |
| Recruitment rates | Through study completion, an average of 6 months | How many eligible patients decide to participate in the study |
| Follow-up rates | Through study completion, an average of 6 months | How many participants complete all follow-up phone calls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 30 days | How many participants experience thromboembolic events, perforation and post-polypectomy electrocoagulation syndrome, seizure activity and vision changes |
| Post-procedure bleeding | Up to 30 days | How many participants experience severe bleeding event that requires hospitalization, transfusion, colonoscopy, surgery or another invasive intervention within 30 days after completion of the colonoscopy with polypectomy |
Countries
Canada
Outcome results
None listed