Chronic Sinusitis
Conditions
Keywords
FESS, Tranexamic acid, Hemostasis, Visualization
Brief summary
Sinus surgery is a common, day surgery procedure performed by general and subspecialty trained otolaryngologists. In most cases, this is a safe surgery with a low incidence of complications. When there is significant bleeding or enough bleeding to obscure important anatomical landmarks, there is a higher chance of complications. These complications can include blindness, meningitis or cerebrospinal fluid leak. Our hypothesis is that in patients taking oral tranexamic acid three days before surgery and six days after, there will be less intraoperative bleeding, better surgical visualization and less postoperative bleeding events.
Interventions
DRUGTranexamic acid
Oral form, 100mg, tid (three times per day), 3 days before/the day of/6 days after the surgery
DRUGPlacebo
Placebo, Oral form, three times a day, 3 days before/day of/6 days after surgery
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic sinusitis requiring bilateral functional endoscopic sinus surgery * Between the ages of 18-65 * Willing to comply with standard followup * No coagulopathy * Not pregnant
Exclusion criteria
* Pregnant * On anticoagulants within 3 months of the surgery * Coagulopathy * \<18 or \>65 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative bleeding amount | During the surgery |
Secondary
| Measure | Time frame |
|---|---|
| Surgical visualization scoring | During the surgery |
| Postoperative bleeding events | Six days after the surgery |
Countries
Canada
Outcome results
None listed