Swallowing Function Before and After Surgery for Thyroid Goiter

Hypothyroidism Clinical Trial

Official title:

Swallowing Function Before and After Surgery for Thyroid Goiter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205348
• Other study ID #: 2002-093
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 18, 2017
• Start date: April 2002
• Est. completion date: January 2009

Study information

• Verified date: August 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

Detailed description not desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• thyroidectomy

Exclusion Criteria:

Related Conditions & MeSH terms

• Goiter
• Hypothyroidism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swallowing Quality of Life	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.	One year