Closure Method Study Following Tonsillectomy in Children

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00730340
First received: August 5, 2008
Last updated: June 14, 2010
Last verified: June 2010
  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
Children
Procedure: Closure of the Tonsillar Fossa
Procedure: Tonsillectomy with open fossa
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decreased Morbidity With Closure of the Tonsillar Fossae

Resource links provided by NLM:


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 ]

Enrollment: 14
Study Start Date: August 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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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

No publications provided

Responsible Party: Wayne E. Berryhill, M.D., University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT00730340     History of Changes
Other Study ID Numbers: Tonsillar Closure_Berryhill
Study First Received: August 5, 2008
Last Updated: June 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Tonsillectomy, tonsillar fossa, wound closure

ClinicalTrials.gov processed this record on August 21, 2014