Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | September 2014 |
| End Date: | April 2018 |
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.
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.
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.
We found this trial at
1
site
Redlands, California 92374
Principal Investigator: Kristin Seiberling, MD
Phone: 909-558-4000
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