Thyroid Dysfunction in Head and Neck Surgery Patients

NCT00592514 | Completed

• 1 other identifier: 45976
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Dysfunction

Keywords

Patients undergoing head and neck surgery that involves the upper aerodigestive tract

Outcome Measures

Primary Outcomes (1)

• Thyroid dysfunction in head and neck surgery patients

  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.

  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.

Secondary Outcomes (1)

• Thyroid dysfunction in head and neck surgery patients

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• Patients undergoing any head and neck surgery requiring entry into the upper aerodigestive tract and thus necessitating the oral administration of the antimicrobial agent povidone-iodine 10%.

You may not qualify if:

• Patients with history of hypothyroidism currently taking thyroid hormone medications (i.e. Synthroid, Levothyroxine, Thyroxine) and women who are pregnant.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

• James Suen, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 14, 2008
• Study Start: July 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 2, 2011

Record last verified: 2011-08

Locations

US (1)