Thyroid Dysfunction in Head and Neck Surgery Patients
| Tracking Information | |||||
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| First Received Date ICMJE | December 27, 2007 | ||||
| Last Updated Date | August 31, 2011 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Thyroid dysfunction in head and neck surgery patients [ Time Frame: Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure. ] [ Designated as safety issue: No ] Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00592514 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Thyroid dysfunction in head and neck surgery patients [ Time Frame: Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 10 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours and 1 week after exposure. ] [ Designated as safety issue: No ] Specific Aim II: Measurement of iodine induced changes in thyroid function. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Thyroid Dysfunction in Head and Neck Surgery Patients | ||||
| Official Title ICMJE | Thyroid Dysfunction in Head and Neck Surgery Patients Treated With Intraoperative Oral Administration With Povidone-iodine 10% Solution | ||||
| Brief Summary | Specific Aim I: Determine absorption of iodine after oropharyngeal application of povidone-iodine 10% solution when used in head and neck surgery involving the upper aero-digestive tract. Specific Aim II: Measurement of iodine induced changes in thyroid function. |
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| Detailed Description | Serial blood draws will be obtained from approximately 10 men and women age 18 and over who have been exposed to intraoperative oropharyngeal application with povidone-iodine 10%. Baseline serum and 24-hour urine iodine levels will be measured preoperatively. Serum iodine levels will be drawn at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. A postoperative 24-hour urine iodine level will also be obtained. With the above measurements, the amount of iodine absorption as well as the time period of peak absorption and duration of elevated iodine levels will be elucidated. Thyroid hormone metabolism is highly dependent on serum levels of iodine. Thyroid function will be assessed by measuring serum levels of free thyroxine, free triiodothyronine, and thyroid stimulating hormone also at 1 hour, 2 hours, 4 hours, 6 hours, 24 hours, 1 week, and 1 month after exposure. Measuring thyroid function is important since hypothyroidism has been known to have a major impact on postoperative wound healing. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary Care Clinic |
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| Condition ICMJE | Thyroid Dysfunction | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | 1. Betadine Solution [product label]. The Purdue Frederick Company. Stamford, CT. 2. Cannon, C. R. Hypothyroidism in head and neck cancer patients: experimental and clinical observations. Laryngoscope. 104(11 Pt 2 Suppl 66):1-21, 1994 Nov. 3. Ferguson, M., Geddes, D., Wray, D. The effect of a povidone-iodine mouthwash upon thyroid function and plaque accumulation. British Dental Journal. 144, 14, 1978. 4. Fradkin, J. E. and Wolff, J. Iodide-Induced Thyrotoxicosis. Medicine, 62, 1-20, 1983. 5. Guyétant, S., et al. Hyperthyroidism induced by amiodarone and hyperthyroidism induced by iodine. Histologic, immunohistochemical and ultrastructural aspects. Annales de Pathologie. 15(6):431-7, 1995. | ||||
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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 | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| 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 | NCT00592514 | ||||
| Other Study ID Numbers ICMJE | 45976 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Arkansas | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | August 2011 | ||||
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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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