NCT00730340

Closure Method Study Following Tonsillectomy in Children

Decreased Morbidity With Closure of the Tonsillar Fossae

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
PROCEDURE	Tonsillectomy with open fossa	SOP for a tonsillectomy.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-08-08
• Last updated: 2010-06-15

Locations

1 site across 1 country: United States