Closure Method Study Following Tonsillectomy in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Decreased Morbidity With Closure of the Tonsillar Fossae

Conditions
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Tonsillectomy, Children

Intervention / Treatment
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* Procedure: Closure of the Tonsillar Fossa
* Procedure: Tonsillectomy with open fossa


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will receive closure of the tonsillar fossae following tonsillectomy. | Procedure: Closure of the Tonsillar Fossa<br>* 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.<br>|
| Active Comparator: 2<br>Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy | Procedure: Tonsillectomy with open fossa<br>* SOP for a tonsillectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced. |  | 10-14 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, tonsillar fossa, wound closure