Closure Method Study Following Tonsillectomy in Children

Early Phase 1

Completed

• Conditions: Tonsillectomy; Children
• Interventions: Procedure: Closure of the Tonsillar Fossa; Procedure: Tonsillectomy with open fossa

• 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-14
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Closure of the Tonsillar Fossa	Patients will receive closure of the tonsillar fossae following tonsillectomy.
2	Tonsillectomy with open fossa	Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy

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