Clinical trial NCT02119273: Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Official title: Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Keywords: CRSsNP
Steroids
Corticosteroids
Endoscopic
Surgery
Perioperative
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lund-Kennedy Endoscopy Score (LKES)
timeFrame: 12 weeks
Secondary outcomes:
measure: Sino-nasal Outcomes Test (SNOT-22)
timeFrame: 12 weeks
measure: Boezaart bleeding score
timeFrame: Day of surgery
measure: Estimated blood loss
timeFrame: Day of surgery
measure: Difficulty of surgery score
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Redlands
country: United States
facility: Loma Linda Sinus and Allergy Center
state: California
Study officials:
affiliation: Loma Linda Department of Otolaryngology
name: Kristin Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References: