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Swallowing Function Before and After Surgery for Thyroid Goiter

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ClinicalTrials.gov Identifier: NCT00205348
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

September 13, 2005
September 20, 2005
June 22, 2012
February 28, 2018
February 28, 2018
April 2002
January 2009   (Final data collection date for primary outcome measure)
Swallowing Quality of Life [ Time Frame: One year ]
The swallowing quality of life (SWAL-QOL) validated outcomes assessment tool will be used before and one year after surgery to measure changes in swallowing-related QOL in patients undergoing thyroid surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable. It has been validated and has favorable psychometric properties, including high internal-consistency reliability and reproducibility. The scales of the instrument differentiate patients with oropharyngeal dysphagia from normal swallowers and are sensitive to clinically-relevant differences in dysphagia severity in patients with medically and surgically treated conditions.
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Complete list of historical versions of study NCT00205348 on ClinicalTrials.gov Archive Site
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Swallowing Function Before and After Surgery for Thyroid Goiter
Swallowing Function Before and After Surgery for Thyroid Goiter
To date, there have been no comprehensive studies on swallowing function in patients undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has significant effect on swallowing function in symptomatic and asymptomatic patients, which can be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2. Surgery will improve swallowing function as measured post-operatively by these same parameters. Patients with multinodular goiter will be asked to fill out a validated survey (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).
Detailed description not desired.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Subjects undergoing thyroid surgery
Hypothyroidism
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
150
January 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • thyroidectomy

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00205348
2002-093
No
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University of Wisconsin, Madison
University of Wisconsin, Madison
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Principal Investigator: Herbert Chen, MD University of Wisconsin Medical School
University of Wisconsin, Madison
August 2017