Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 2 - 12 |
| Updated: | 4/2/2016 |
| Start Date: | March 2009 |
| Contact: | Mira Shiloach, MS CCRP |
| Email: | mshiloach@northshore.org |
| Phone: | (847) 657-1750 |
A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
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.
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.
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.
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