Closure Method Study Following Tonsillectomy in Children

NCT ID: NCT00730340

Last Updated: 2010-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-06-30

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.

Conditions

Tonsillectomy; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Patients will receive closure of the tonsillar fossae following tonsillectomy.

Group Type: ACTIVE_COMPARATOR

Closure of the Tonsillar Fossa

Intervention Type: PROCEDURE

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.

2

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

Group Type: ACTIVE_COMPARATOR

Tonsillectomy with open fossa

Intervention Type: PROCEDURE

SOP for a tonsillectomy.

Interventions

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.

Intervention Type: PROCEDURE

Tonsillectomy with open fossa

SOP for a tonsillectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

University of Oklahoma Health Sciences Center

Principal Investigators

Wayne E Berryhill, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

Tonsillar Closure_Berryhill

Identifier Type: -

Identifier Source: org_study_id