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Clinical Trials/NCT06194097
NCT06194097
Withdrawn
Not Applicable

Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

State University of New York - Upstate Medical University1 site in 1 countryJuly 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sinusitis in Children
Sponsor
State University of New York - Upstate Medical University
Locations
1
Primary Endpoint
surgical outcome
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.

Detailed Description

This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.

Registry
clinicaltrials.gov
Start Date
July 25, 2017
End Date
July 25, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria:
  • Age 6-12 at time of study enrollment. Presence of chronic sinusitis: \>90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.
  • Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist

Exclusion Criteria

  • Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.

Outcomes

Primary Outcomes

surgical outcome

Time Frame: 1 year

Study Sites (1)

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