ClinicalTrials.gov
ClinicalTrials.gov Menu

Swallowing Function Before and After Surgery for Thyroid Goiter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Brief 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).

Condition or disease
Hypothyroidism

Detailed Description:
Detailed description not desired.

Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Swallowing Function Before and After Surgery for Thyroid Goiter
Study Start Date : April 2002
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects undergoing thyroid surgery
Criteria

Inclusion Criteria:

  • thyroidectomy

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205348


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Herbert Chen, MD University of Wisconsin Medical School

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205348     History of Changes
Other Study ID Numbers: 2002-093
First Posted: September 20, 2005    Key Record Dates
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018
Last Verified: August 2017

Additional relevant MeSH terms:
Hypothyroidism
Goiter
Thyroid Diseases
Endocrine System Diseases