HyperparathyroidismNCT03968510
Swalqol in Primary Hyperparathyroidism
An observational study of Hyperparathyroidism, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Nov 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with primary hyperparathyroidism
Who may be able to join
- no diagnosis of Alzheimers disease
- must be able to swallow tablets Planned operation for primary hyperparathyroidism
Who cannot join
- secondary or tertiary hyperparathyroidism
- insulin dependent diabetes
- thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperparathyroidism
- Being tested
- parathyroidectomy
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
routine parathyroidectomy will be done for the treatment of adenoma
| Study group | Role | What they receive |
|---|---|---|
| parathyroidectomy cases | patients who will be operated for primary hyperparathyroidism Receives: Procedure: parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
Quality of life will be evaluated using short form 36
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış Sevinç, Uşak University
- Investigators
- Barış Sevinç, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968510
- Sponsor's protocol ID
- pthswalqol
- Status last verified
- Jun 2021
- First submitted
- 20 Mar 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03968510
- Acronym / sponsor ID
- pthswalqol
- Conditions
- Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parathyroidectomy cases | – | Procedure: parathyroidectomypatients who will be operated for primary hyperparathyroidism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary hyperparathyroidism
Key inclusion criteria (2 listed)
- no diagnosis of Alzheimers disease
- must be able to swallow tablets Planned operation for primary hyperparathyroidism
Key exclusion criteria (3 listed)
- secondary or tertiary hyperparathyroidism
- insulin dependent diabetes
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroidectomyroutine parathyroidectomy will be done for the treatment of adenoma | Procedure or surgery | parathyroidectomy cases |
Primary outcome
Change in quality of life
Time frame: 6 months
Quality of life will be evaluated using short form 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barış Sevinç principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.