Chronic Sinus Disease, Chronic Sinusitis, Ethmoidal, Chronic Sinusitis - Frontoethmoidal, Chronic Sinusitis - Maxillary Bilateral, Chronic Sinusitis, Sphenoidal
Conditions
Brief summary
Randomized controlled trial to determine the effectiveness of a five-day course of pre-operative oral steroids on decreasing intra-operative blood loss during endoscopic sinus surgery.
Detailed description
The study will be a randomized cohort study, and patients will be recruited before surgery. Following randomization, patients will be given either a course of Prednisone (30 milligrams per day for 5 days, to be started five days prior to surgery) or no additional pre-operative prescriptions besides what is clinically determined by their treating physician. Patients will be scheduled for surgery and undergo functional endoscopic sinus surgery with timing as clinically indicated. During endoscopic sinus surgery, surgical video will be recorded and stored on encrypted, flash drives with unique, non PHI, indicators to identify drives. Subsequently, each video will be graded by two, blinded surgeons for field visualization and thoroughness of dissection. Intra-operative blood loss will also be recorded. Post-operative data through 30 days post-operatively will be collected including: post-operative complications, resolution of symptoms, and nasal crusting during post-operative follow up. Following completion of data collection, these data will be analyzed by a separate, blinded investigator.
Interventions
DRUGPrednisone
5 day course of oral prednisone pre-operatively. 30mg per day.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinicians grading blood loss and surgical field disability on the recorded video footage will be blinded to patient identity and group status. Data analysis will be done by a blinded assessor.
Intervention model description
Patient's will be randomized to one of two groups: pre-operative oral steroids or no control
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients between the ages of 18 and 99 years of age with a diagnosis of chronic rhinosinusitis without polyps who are being scheduled for functional endoscopic sinus surgery
Exclusion criteria
* Patients under 18 years old, patients with a condition in which the use of systemic corticosteroids is contraindicated (poorly controlled diabetes mellitus, poorly controlled hypertension, active or untreated tuberculosis, active viral or fungal infection, acute angle glaucoma, osteoporosis, or acute congestive heart failure) patients allergic to corticosteroids, or, patients unwilling or unable to take the prescribed course of pre-operative steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative blood loss - 1 | Intra-operative | Measured intra-operative blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\]) |
| Intra-operative blood loss - 2 | Intra-operative | Blinded assessors grading of blood loss (in milliliters) as assessed by standard measure (total of blood in the suction canister \[less the irrigation used\]) |
| Surgical field visibility | Intra-operative | Blinded assessor's grading of surgical field visualization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient intolerance of steroids | Pre-operative | Patient report of intolerable adverse effects of pre-operative steroids |
Outcome results
None listed