Swalqol in Primary Hyperparathyroidism

Sponsor

Uşak University (Other)

Overall Status

Completed

CT.gov ID

NCT03968510

Collaborator

(none)

150

Enrollment

Location

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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	Phase
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

Official Title:

The Effect of Parathyroidectomy on Swallowing Related Quality of Life in Primary Hyperparathyroidism

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
parathyroidectomy cases patients who will be operated for primary hyperparathyroidism	Procedure: parathyroidectomy routine parathyroidectomy will be done for the treatment of adenoma

Arm

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 [6 months]
Quality of life will be evaluated using short form 36

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Uşak University	Uşak		Turkey	64100

Sponsors and Collaborators

Uşak University

Investigators

Principal Investigator: Barış Sevinç, Uşak University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Barış Sevinç, Assistant professor, Uşak University

ClinicalTrials.gov Identifier:

NCT03968510

Other Study ID Numbers:

pthswalqol

First Posted:

May 30, 2019

Last Update Posted:

Jun 4, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperparathyroidism

Hyperparathyroidism, Primary

Study Results

No Results Posted as of Jun 4, 2021