Hypothyroidism
Conditions
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).
Detailed description
Detailed description not desired.
Interventions
None listed
Sponsors
University of Wisconsin, Madison
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* thyroidectomy
Exclusion criteria
* na
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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.
Participants by arm
| Arm | Count |
|---|---|
| SWAL-QOL Questionnaire 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. | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | SWAL-QOL Questionnaire |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 116 participants |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
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.
Time frame: One year
Population: All data will be analyzed using standard statistical tools including student T-test and ANOVA.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Burden Score Before Surgery | 84.6 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Burden Score After Surgery | 92.3 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Physical Score Before Surgery | 81.2 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Physical Score After Surgery | 87.1 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Mental Score Before Surgery | 87.0 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Mental Score After Surgery | 93.1 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Fear Score Before Surgery | 87.0 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Fear Score After Surgery | 92.9 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Eating Desire Score Before Surgery | 92.5 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Eating Desire Score After Surgery | 94.5 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Eating Duration Score Before Surgery | 86.2 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Eating Duration Score After Surgery | 88.4 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Food Selection Score Before Surgery | 88.5 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Food Selection Score After Surgery | 93.8 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Sleep Score Before Surgery | 65.0 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Sleep Score After Surgery | 73.6 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Fatigue Score Before Surgery | 63.4 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Fatigue Score After Surgery | 71.5 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Social Score Before Surgery | 94.4 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Social Score After Surgery | 95.6 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Communication Score Before Surgery | 88.9 units on a scale |
| SWAL-QOL Questionnaire | Swallowing Quality of Life | Communication Score After Surgery | 91.9 units on a scale |
Comparison: The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.p-value: 0.0973Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.p-value: 0.0007Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.p-value: 0.0002Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.p-value: 0.1772Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.p-value: 0.0062Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.p-value: <0.0001Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.p-value: 0.0002Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.p-value: 0.2125Wilcoxon (Mann-Whitney)
Comparison: The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.p-value: 0.0332Wilcoxon (Mann-Whitney)