Closure Method Study Following Tonsillectomy in Children - Full Text View

Purpose

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

Condition	Intervention	Phase
Tonsillectomy on Children	Procedure: Closure of the Tonsillar Fossa Procedure: Tonsillectomy with open fossa	Phase 0

MedlinePlus related topics:

Tonsils and Adenoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety Study

Official Title:	Decreased Morbidity With Closure of the Tonsillar Fossae

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The patients will also be examined in the clinic postoperatively to determine if the fossae remained closed or dehisced. [ Time Frame: 10-14 days postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy	Procedure: Tonsillectomy with open fossa SOP for a tonsillectomy.

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.

Eligibility

Ages Eligible for Study:	5 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730340

Locations


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

Sponsors and Collaborators

University of Oklahoma

Investigators


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

More Information

Responsible Party:	University of Oklahoma Health Sciences Center ( Wayne E. Berryhill, M.D. )
Study ID Numbers:	Tonsillar Closure_Berryhill
First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730340
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Tonsillectomy, tonsillar fossa, wound closure

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00730340