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

August 5, 2008
June 14, 2010
August 2008
June 2010   (final data collection date for primary outcome measure)
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00730340 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Tonsillectomy
  • Children
  • 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.
  • Active Comparator: 1
    Patients will receive closure of the tonsillar fossae following tonsillectomy.
    Intervention: Procedure: Closure of the Tonsillar Fossa
  • Active Comparator: 2
    Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy
    Intervention: Procedure: Tonsillectomy with open fossa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
5 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730340
Tonsillar Closure_Berryhill
No
Wayne E. Berryhill, M.D., University of Oklahoma Health Sciences Center
University of Oklahoma
Not Provided
Principal Investigator: Wayne E Berryhill, M.D. University of Oklahoma
University of Oklahoma
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP