Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

August 24, 2021 updated by: Uppsala University

Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort

Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.

Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Anticipated)

1700

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

  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients are identified through the national quality registry for endocrine surgery, SQRTPA and the Swedish National Patient Register

Description

Inclusion Criteria:

  • Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.

Exclusion Criteria:

  • Malignancy
  • Sternotomy
  • Previous thyroid surgery
  • Previous or concurrent parathyroidectomy

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
Patients with permanent hypoparathyroidism after total thyroidectomy
Patients with permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. Permanent hypoparathyroidism is defined as treatment with Calcium and/or vitamin D more than 12 months after surgery.
Patients without permanent hypoparathyroidism after total thyroidectomy
Patients without permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life using SF-36 short form
Time Frame: 2021
The SF-36 yields eight scale scores and two summary scores, the physical component summary (PCS) and mental component summary (MCS). Scoring PCS and MCS involves three steps: 1) standardization of the scales (z-scores) 2) aggregation of score scales and 3) transformation of summary scores (t-scores). For each domain (PCS and MCS) the mean score is 50 with a standard deviation of 10. Higher scores indicates better quality of life (score range 0-100)
2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Olov Norlén, MD, PhD, Uppsala 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 (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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