Trial Outcomes & Findings for Swallowing Function Before and After Surgery for Thyroid Goiter (NCT NCT00205348)
NCT ID: NCT00205348
Last Updated: 2018-02-28
Results Overview
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.
COMPLETED
146 participants
One year
2018-02-28
Participant Flow
Patients undergoing thyroid surgery from May 2002 to December 2004 completed the SWAL-QOL questionnaire before and one year after surgery.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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146
|
|
Overall Study
COMPLETED
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116
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Swallowing Function Before and After Surgery for Thyroid Goiter
Baseline characteristics by cohort
| Measure |
SWAL-QOL Questionnaire
n=116 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
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94 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
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Region of Enrollment
United States
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116 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: All data will be analyzed using standard statistical tools including student T-test and ANOVA.
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.
Outcome measures
| Measure |
SWAL-QOL Questionnaire
n=116 Participants
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.
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|---|---|
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Swallowing Quality of Life
Burden Score Before Surgery
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84.6 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Burden Score After Surgery
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92.3 units on a scale
Interval 0.0 to 100.0
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|
Swallowing Quality of Life
Physical Score Before Surgery
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81.2 units on a scale
Interval 19.6 to 100.0
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|
Swallowing Quality of Life
Physical Score After Surgery
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87.1 units on a scale
Interval 26.8 to 100.0
|
|
Swallowing Quality of Life
Mental Score Before Surgery
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87.0 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Mental Score After Surgery
|
93.1 units on a scale
Interval 10.0 to 100.0
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|
Swallowing Quality of Life
Fear Score Before Surgery
|
87.0 units on a scale
Interval 12.5 to 100.0
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Swallowing Quality of Life
Fear Score After Surgery
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92.9 units on a scale
Interval 25.0 to 100.0
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Swallowing Quality of Life
Eating Desire Score Before Surgery
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92.5 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Eating Desire Score After Surgery
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94.5 units on a scale
Interval 25.0 to 100.0
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|
Swallowing Quality of Life
Eating Duration Score Before Surgery
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86.2 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Eating Duration Score After Surgery
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88.4 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Food Selection Score Before Surgery
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88.5 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Food Selection Score After Surgery
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93.8 units on a scale
Interval 25.0 to 100.0
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Swallowing Quality of Life
Sleep Score Before Surgery
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65.0 units on a scale
Interval 0.0 to 100.0
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Swallowing Quality of Life
Sleep Score After Surgery
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73.6 units on a scale
Interval 0.0 to 100.0
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|
Swallowing Quality of Life
Fatigue Score Before Surgery
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63.4 units on a scale
Interval 0.0 to 100.0
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|
Swallowing Quality of Life
Fatigue Score After Surgery
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71.5 units on a scale
Interval 0.0 to 100.0
|
|
Swallowing Quality of Life
Social Score Before Surgery
|
94.4 units on a scale
Interval 20.0 to 100.0
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|
Swallowing Quality of Life
Social Score After Surgery
|
95.6 units on a scale
Interval 25.0 to 100.0
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|
Swallowing Quality of Life
Communication Score Before Surgery
|
88.9 units on a scale
Interval 0.0 to 100.0
|
|
Swallowing Quality of Life
Communication Score After Surgery
|
91.9 units on a scale
Interval 25.0 to 100.0
|
Adverse Events
SWAL-QOL Questionnaire
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place