An Early Phase 1 interventional study of Closure of the Tonsillar Fossa and Tonsillectomy with open fossa in Tonsillectomy and Children, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2010-06-15.
Sponsored by University of Oklahoma · Early Phase 1, Interventional, and Treatment
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.
University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive closure of the tonsillar fossae following tonsillectomy.
Procedure: Closure of the Tonsillar Fossa
Patients will not receive closure to one or both tonsillar fossa following a tonsillectomy
Procedure: Tonsillectomy with open 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.
SOP for a tonsillectomy.
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure
Time frame: 6 months
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
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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University of Oklahoma