Closure Method Study Following Tonsillectomy in Children
- Conditions
- TonsillectomyChildren
- Registration Number
- NCT00730340
- Lead Sponsor
- University of Oklahoma
- Brief Summary
This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.
- Detailed Description
This is a children's study. Patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. We are going to compare the effects of closing the tonsil wound versus non-closure. A daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. Postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. The patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Normal children between that ages of five to ten requiring a tonsillectomy
- Children older than ten years of age.
- Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure 6 months
- Secondary Outcome Measures
Name Time Method The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced. 10-14 days postoperatively
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center🇺🇸Oklahoma City, Oklahoma, United States