Closure Method Study Following Tonsillectomy in Children

University of Oklahoma (OU)

Status and phase: Completed; Early Phase 1

Conditions: Children; Tonsillectomy

Treatments: Procedure: Closure of the Tonsillar Fossa; Procedure: Tonsillectomy with open fossa

Study type: Interventional

Funder types: Other

Identifiers

NCT00730340

Tonsillar Closure_Berryhill

Details and patient eligibility

About

This is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

1

Active Comparator group

Description:

Patients will receive closure of the tonsillar fossae following tonsillectomy.

Treatment:

Procedure: Closure of the Tonsillar Fossa

2

Active Comparator group

Description:

Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy

Treatment:

Procedure: Tonsillectomy with open fossa