Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Conditions
Keywords
CRSsNP, Steroids, Corticosteroids, Endoscopic, Surgery, Perioperative
Brief summary
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.
Interventions
DRUGPrednisone
See arm description
DRUGPlacebo
See arm description
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study. * Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines. * These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms. * These symptoms must include at least one of the following: * nasal obstruction * rhinorrhea * postnasal drip. * Additional symptoms can include facial pain/pressure or anosmia/hyposmia. * These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes. * The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).
Exclusion criteria
* Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings. * Additionally, patients with known immunocompromise or mucociliary disorders will be excluded. * Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lund-Kennedy Endoscopy Score (LKES) | 12 weeks | Objective endoscopic measure of sino-nasal mucosal health |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sino-nasal Outcomes Test (SNOT-22) | 12 weeks | Patient completed survey that objectifies sinonasal symptoms |
| Boezaart bleeding score | Day of surgery | Surgeon completed survey of bleeding during surgery |
| Estimated blood loss | Day of surgery | Estimation of blood lost during surgery, as reported by anesthesiologist |
| Difficulty of surgery score | Day of surgery | Surgeon completed survey of surgical difficulty |
Countries
United States
Outcome results
None listed