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出境医 / 临床实验 / Swalqol in Primary Hyperparathyroidism
Swalqol in Primary Hyperparathyroidism
Study Description
Brief Summary:
Swallow related quality of life before and after parathyroidectomy will be evaluated in patients with primary hyperparathyridism.
| Condition or disease | Intervention/treatment |
|---|---|
| Hyperparathyroidism | Procedure: parathyroidectomy |
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
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 150 participants |
| Observational Model: | Case-Crossover |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 6 Months |
| Official Title: | The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism |
| Actual Study Start Date : | November 1, 2018 |
| Actual Primary Completion Date : | July 1, 2020 |
| Actual Study Completion Date : | November 1, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
parathyroidectomy cases
patients who will be operated for primary hyperparathyroidism
|
Procedure: parathyroidectomy
routine parathyroidectomy will be done for the treatment of adenoma
|
Outcome Measures
Primary Outcome Measures :
- Change in quality of life [ Time Frame: 6 months ]Quality of life will be evaluated using short form 36
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with primary hyperparathyroidism
Criteria
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
Contacts and Locations
Locations
| Turkey | |
| Uşak University | |
| Uşak, Turkey, 64100 | |
Sponsors and Collaborators
Uşak University
Investigators
| Principal Investigator: | Barış Sevinç | Uşak University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | March 20, 2019 | ||||
| First Posted Date | May 30, 2019 | ||||
| Last Update Posted Date | June 4, 2021 | ||||
| Actual Study Start Date | November 1, 2018 | ||||
| Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Change in quality of life [ Time Frame: 6 months ] Quality of life will be evaluated using short form 36
|
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| Original Primary Outcome Measures |
Change in quality of life [ Time Frame: 1 month ] Quality of life will be evaluated using shirt form 36
|
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Swalqol in Primary Hyperparathyroidism | ||||
| Official Title | The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism | ||||
| Brief Summary | 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 Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Crossover Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 6 Months | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patients with primary hyperparathyroidism | ||||
| Condition | Hyperparathyroidism | ||||
| Intervention | Procedure: parathyroidectomy
routine parathyroidectomy will be done for the treatment of adenoma
|
||||
| Study Groups/Cohorts | parathyroidectomy cases
patients who will be operated for primary hyperparathyroidism
Intervention: Procedure: parathyroidectomy
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
150 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | November 1, 2020 | ||||
| Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03968510 | ||||
| Other Study ID Numbers | pthswalqol | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Barış Sevinç, Uşak University | ||||
| Study Sponsor | Uşak University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Uşak University | ||||
| Verification Date | June 2021 | ||||
