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Closure Method Study Following Tonsillectomy in Children

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ClinicalTrials.gov Identifier: NCT00730340
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : June 15, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Children Procedure: Closure of the Tonsillar Fossa Procedure: Tonsillectomy with open fossa Early Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Decreased Morbidity With Closure of the Tonsillar Fossae
Study Start Date : August 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: 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
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010

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