Swallowing Function Before and After Surgery for Thyroid Goiter

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00205348
• Collaborator: (none)
• Enrollment: 146
• Duration (Months): 81.1

Study Details

Study Description

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	Intervention/Treatment	Phase
Hypothyroidism

Detailed Description

Detailed description not desired.

Study Design

• 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: Apr 1, 2002
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Outcome Measures

Primary Outcome Measures

1. Swallowing Quality of Life [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• thyroidectomy

Exclusion Criteria:

• na

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Herbert Chen, MD, University of Wisconsin Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00205348
• Other Study ID Numbers: 2002-093
• First Posted: Sep 20, 2005
• Last Update Posted: Feb 28, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Hypothyroidism

Study Results

Participant Flow

Recruitment Details	Patients undergoing thyroid surgery from May 2002 to December 2004 completed the SWAL-QOL questionnaire before and one year after surgery.

Arm/Group Title	SWAL-QOL Questionnaire
Arm/Group Description	Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after 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.
Period Title: Overall Study
STARTED	146
COMPLETED	116
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	SWAL-QOL Questionnaire
Arm/Group Description	Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after 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.
Overall Participants	116
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	116 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (13)
Sex: Female, Male (Count of Participants)
Female	94 81%
Male	22 19%
Region of Enrollment (participants) [Number]
United States	116 100%

Outcome Measures

1. Primary Outcome

Title	Swallowing Quality of Life
Description	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.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

All data will be analyzed using standard statistical tools including student T-test and ANOVA.

Arm/Group Title	SWAL-QOL Questionnaire
Arm/Group Description	Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after 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.
Measure Participants	116
Burden Score Before Surgery	84.6
Burden Score After Surgery	92.3
Physical Score Before Surgery	81.2
Physical Score After Surgery	87.1
Mental Score Before Surgery	87.0
Mental Score After Surgery	93.1
Fear Score Before Surgery	87.0
Fear Score After Surgery	92.9
Eating Desire Score Before Surgery	92.5
Eating Desire Score After Surgery	94.5
Eating Duration Score Before Surgery	86.2
Eating Duration Score After Surgery	88.4
Food Selection Score Before Surgery	88.5
Food Selection Score After Surgery	93.8
Sleep Score Before Surgery	65.0
Sleep Score After Surgery	73.6
Fatigue Score Before Surgery	63.4
Fatigue Score After Surgery	71.5
Social Score Before Surgery	94.4
Social Score After Surgery	95.6
Communication Score Before Surgery	88.9
Communication Score After Surgery	91.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0973
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1772
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0062
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2125
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	SWAL-QOL Questionnaire
	Comments	The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0332
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	SWAL-QOL Questionnaire
Arm/Group Description	Patients undergoing thyroid surgery from May 2002 to December 2004 completed the Swallowing Quality Of Life (SWAL-QOL)questionnaire before and one year after 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.
All Cause Mortality
	SWAL-QOL Questionnaire
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SWAL-QOL Questionnaire
	Affected / at Risk (%)	# Events
Total	0/116 (0%)
Other (Not Including Serious) Adverse Events
	SWAL-QOL Questionnaire
	Affected / at Risk (%)	# Events
Total	0/116 (0%)

Limitations/Caveats

There are no limitations or caveats to report.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.