Pediatric Chronic Rhinosinusitis in Asthmatic Children

Not Applicable

Withdrawn

• Conditions: Sinusitis in Children
• Interventions: Procedure: adenoidectomy versus endoscopic sinus surgery with adenoidectomy

• Registration Number: NCT06194097
• Lead Sponsor: State University of New York - Upstate Medical University

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.

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-11-01
• Primary Completion: 2020-07-25
• Study Completion: 2020-07-25
• Status Verified: 2021-04
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic Sinus surgery and Adenoidectomy	adenoidectomy versus endoscopic sinus surgery with adenoidectomy	-
Adenoidectomy	adenoidectomy versus endoscopic sinus surgery with adenoidectomy	-

Primary Outcome Measures

Name	Time	Method
surgical outcome	1 year

Trial Locations

Locations (1)

SUNY Upstate Medical Center; 🇺🇸 Syracuse, New York, United States