Closure Method Study Following Tonsillectomy in Children

Children Clinical Trial

Official title:

Decreased Morbidity With Closure of the Tonsillar Fossae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730340
• Other study ID #: Tonsillar Closure_Berryhill
• Status: Completed
• Phase: Phase 0
• First received: August 5, 2008
• Last updated: June 14, 2010
• Start date: August 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Tonsillectomy

Intervention

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.
• Tonsillectomy with open fossa
SOP for a tonsillectomy.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure		6 months	No
Secondary	The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced.		10-14 days postoperatively	No