Pediatric Chronic Rhinosinusitis in Asthmatic Children

State University of New York - Upstate Medical University

Status

Withdrawn

Conditions

Sinusitis in Children

Treatments

Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06194097

1009628-5

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.