Closure Method Study Following Tonsillectomy in Children
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2008 | ||||
| Last Updated Date | June 14, 2010 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Decreased morbidity in children with closure of the tonsillar fossae compared with tonsillectomy without closure [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00730340 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Closure Method Study Following Tonsillectomy in Children | ||||
| Official Title ICMJE | Decreased Morbidity With Closure of the Tonsillar Fossae | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 14 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 10 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00730340 | ||||
| Other Study ID Numbers ICMJE | Tonsillar Closure_Berryhill | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wayne E. Berryhill, M.D., University of Oklahoma Health Sciences Center | ||||
| Study Sponsor ICMJE | University of Oklahoma | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Oklahoma | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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