Sinusitis in Children
Conditions
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.
Interventions
PROCEDUREadenoidectomy versus endoscopic sinus surgery with adenoidectomy
adenoidectomy versus endoscopic sinus surgery
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgical outcome | 1 year |
Countries
United States
Outcome results
None listed