- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03968510
Swalqol in Primary Hyperparathyroidism
June 1, 2021 updated by: Barış Sevinç, Uşak University
The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism
Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients who will undergone parathyroidectomy for primary hyperparathyroidism will be included in the study.
Swal-Qol and Sf-36 forms will be used for evaluation of quality of life before and 1 month after the surgery.
The change in the quality of life and swallowing related quality of life will be evaluated.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Uşak, Turkey, 64100
- Uşak University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with primary hyperparathyroidism
Description
Inclusion Criteria:
- no diagnosis of Alzheimers disease
- must be able to swallow tablets Planned operation for primary hyperparathyroidism
Exclusion Criteria:
- secondary or tertiary hyperparathyroidism
- insulin dependent diabetes
- thyroid disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
parathyroidectomy cases
patients who will be operated for primary hyperparathyroidism
|
routine parathyroidectomy will be done for the treatment of adenoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life
Time Frame: 6 months
|
Quality of life will be evaluated using short form 36
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barış Sevinç, Uşak University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2018
Primary Completion (ACTUAL)
July 1, 2020
Study Completion (ACTUAL)
November 1, 2020
Study Registration Dates
First Submitted
March 20, 2019
First Submitted That Met QC Criteria
May 27, 2019
First Posted (ACTUAL)
May 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 4, 2021
Last Update Submitted That Met QC Criteria
June 1, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pthswalqol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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