Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

NorthShore University HealthSystem

Status: Completed

Conditions: Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis

Treatments: Device: Acclarent Relieva Balloon Sinuplasty; Procedure: Adenoidectomy + Maxillary Sinus Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT01990820

EH09-177

Details and patient eligibility

About

Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease. Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of the throat) is performed since the adenoid pad may trap germs that enter a child's body and can get so swollen with bacteria that they become infected themselves. Functional endoscopic sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on children with this disease. Another treatment is adenoidectomy and irrigation of the maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon dilation of the maxillary sinus passage and irrigation experience improved quality of life outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with maxillary sinus irrigation without dilation of the sinus passage.

Enrollment: 25 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis >3x/year
2. Failure to respond to 3-week course of antibiotic and 3 month course of nasal steroid preparations or antihistamines as well as saline nasal irrigation
3. Rhinosinusitis documented by CT scan following oral antibiotic course.

Computer tomographic findings considered to be consistent with sinusitis include partial or complete sinus opacification.

Allergy and immunology workup will be recommended on an individual basis -

Exclusion criteria

1. Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
2. History of facial trauma that distorts sinus anatomy
3. Ciliary dysfunction
4. Pregnancy will be excluded.
5. Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
6. Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
7. Patients with a history of sinus surgery or significant anatomic abnormalities on CT scan that would require endoscopic sinus surgery or septoplasty would also be excluded.

Of note, children who will be undergoing concurrent surgeries will not be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Adenoidectomy without balloon dilation

Active Comparator group

Description:

Subjects will have Adenoidectomy + maxillary sinus irrigation, without balloon dilation.

Treatment:

Procedure: Adenoidectomy + Maxillary Sinus Irrigation

Adenoidectomy with balloon dilation

Experimental group

Description:

Adenoidectomy + balloon dilation of maxillary sinus ostia using Acclarent Relieva Balloon Sinuplasty + irrigation

Treatment:

Device: Acclarent Relieva Balloon Sinuplasty