Closure Method Study Following Tonsillectomy in Children

Decreased Morbidity With Closure of the Tonsillar Fossae

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

Study Overview

• Status: Completed
• Conditions: Children; Tonsillectomy
• Intervention / Treatment: Procedure: Closure of the Tonsillar Fossa; Procedure: Tonsillectomy with open fossa

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Wayne E Berryhill, M.D., University of Oklahoma

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 5, 2008
• First Submitted That Met QC Criteria: August 7, 2008
• First Posted (Estimate): August 8, 2008

Study Record Updates

• Last Update Posted (Estimate): June 15, 2010
• Last Update Submitted That Met QC Criteria: June 14, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Tonsillectomy, tonsillar fossa, wound closure
• Other Study ID Numbers: Tonsillar Closure_Berryhill