Closure Method Study Following Tonsillectomy in Children
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Purpose
This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.
| Condition | Intervention | Phase |
|---|---|---|
|
Tonsillectomy Children |
Procedure: Closure of the Tonsillar Fossa Procedure: Tonsillectomy with open fossa |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Decreased Morbidity With Closure of the Tonsillar Fossae |
- Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced. [ Time Frame: 10-14 days postoperatively ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | August 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Patients will receive closure of the tonsillar fossae following tonsillectomy.
|
Procedure: Closure of the Tonsillar Fossa
We hypothesize that closure of the tonsillar fossa decreases the morbidity of pain by decreasing exposure of the raw operative bed to oral secretions, mediation, and oral intake, and decreases the morbidity of post-operative hemorrhage by having the operative wound closed.
|
|
Active Comparator: 2
Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy
|
Procedure: Tonsillectomy with open fossa
SOP for a tonsillectomy.
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Normal children between that ages of five to ten requiring a tonsillectomy
Exclusion Criteria:
- Children older than ten years of age.
- Those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.
Contacts and Locations| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Wayne E Berryhill, M.D. | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | Wayne E. Berryhill, M.D., University of Oklahoma Health Sciences Center |
| ClinicalTrials.gov Identifier: | NCT00730340 History of Changes |
| Other Study ID Numbers: | Tonsillar Closure_Berryhill |
| Study First Received: | August 5, 2008 |
| Last Updated: | June 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
Tonsillectomy, tonsillar fossa, wound closure |
ClinicalTrials.gov processed this record on June 17, 2013