Choanal Atresia
Conditions
Brief summary
This study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. Participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.
Detailed description
Objective: To determine the utility of mometasone eluting stents in the treatment of choanal atresia. Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery Study Design: Randomized, single blind control trial Methods: This study will be a randomized, prospective single-blinded control trial. Inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. Following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). Subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. Multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers. Analysis: Descriptive statistical analysis and multivariate analysis will be performed.
Interventions
DRUGDrug-eluting Stent Mometasone
The subject will have a mometasone drug-eluting stent placed during their choanal atresia repair procedure instead of no stent being placed.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study.
Exclusion criteria
* Those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Posterior Nasal Cavity | 12 Months | Once photodocumentation from followup visits is collected, the images will be collected by a member of the team and given to two independent expert blinded reviewers for assessment of the size of the posterior nasal cavity. The picture will be obtained from the same anatomical position for each scope (the posterior portion of the inferior turbinate) and compared to the picture immediately after surgery of the posterior nasal cavity to assess any changes in size. Reviewers will assess the size of the posterior nasal cavity in each subsequent scope and categorize subjects based on the following sizes (0-50%, 51-75%, 76-100%). |
Countries
United States
Outcome results
None listed