Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis Clinical Trial
Official title:
A Randomized Trial of the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinusplasty
| NCT number | NCT01990820 |
| Other study ID # | EH09-177 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2009 |
| Est. completion date | September 29, 2016 |
| Verified date | February 2020 |
| Source | NorthShore University HealthSystem |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | September 29, 2016 |
| Est. primary completion date | September 29, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 12 Years |
| Eligibility |
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. - |
| Country | Name | City | State |
|---|---|---|---|
| United States | NorthShore University HealthSystem | Evanston | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| NorthShore University HealthSystem |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia. | The care giver for each subject will be asked to complete SN-5 Pediatric sinonasal symptom survey (SN-5) at baseline (prior to surgery) and 6 and 12 months post surgery. The SN-5 is a health-related qualify of life (QOL) questionnaire which consists of 5 questions about sinus problems (sinus infection, nasal obstruction, allergy symptoms, emotional distress, activity limitations) each of which is scored by the caregiver on a 7 point response scale. The 5 responses are then averaged into an SN-5 overall score (1-7). 1 is the minimum value for the overall SN-5 (best QoL) and 7 is the maximum value (worst QoL) The questionnaire also asks the caregiver to grade overall health related quality of life using a visual analog scale from 0 (worse possible quality of life) to 10 (best possible quality of life). The visual analog scale is scored separately from the SN-5 average score. |
6 and 12 months postoperatively |