Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)
1 other identifier
observational
143
1 country
6
Brief Summary
Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. The hypothesis of the investigators is that the mental health is impaired in hypoparathyroid patients compared with thyroidectomized patients without hypoparathyroidism. The investigators evaluated the quality of life using the SF-36 survey in comparison with a control population of patients thyroidectomized but free from this complication. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 12, 2019
CompletedStudy Start
First participant enrolled
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2020
CompletedAugust 7, 2020
August 1, 2020
5 months
May 22, 2019
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mental health
Items from mental quality of life score defined by the SF36 (Short Form 36) survey
Through study completion, an average of 1 year
Secondary Outcomes (6)
Physical quality score
Through study completion, an average of 1 year
Global quality of life score
Through study completion, an average of 1 year
Voice quality
Through study completion, an average of 1 year
Renal function quality
Through study completion, an average of 1 year
Presence of urinary lithiasis
Through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (2)
Hypoparathyroid patients
Patients with persistent hypoparathyroidism after total thyroidectomy, defined as serum PTH inferior to 15 pg/mL 6 months after surgery and the need of vitamin-calcic supplementation.
Control patients, without hypoparathyroidism
Interventions
Non-interventional study
Eligibility Criteria
The study population is that of hypoparathyroid patients of the Hypoparathyroidism France combination who have undergone total thyroidectomy and who have agreed to participate in the study. Patients with permanent hypoparathyroidism who were included in the ThyrQol study and in the FOTHYR study will also be solicited. Endocrinologists at the University Hospital of Nantes also have patients with permanent hypoparathyroidism in their patients. The control population consists of patients who had a total thyroidectomy and were included in the ThyrQol study between 2014 and 2018, without sequelary hypoparathyroidism.
You may qualify if:
- Patients operated of total thyroidectomy
- Patients suffering from persistent hypoparathyroidism defined as serum PTH inferior to 15 pg/mL 6 months after the surgery, requiring vitamin-calcic supplementation.
- Age superior to 18
- Answering the survey
You may not qualify if:
- Pregnancy at the time of the study
- Age inferior to 18 or adult under guardianship
- Patients with vitamino-calcic supplementation without serum PTH measurement
- Cause of hypoparathyroidism other than post-operatory.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nantes University Hospitallead
- University Hospital, Angerscollaborator
- Centre Hospitalier le Manscollaborator
- University Hospital, Limogescollaborator
- Central Hospital, Nancy, Francecollaborator
- Pitié-Salpêtrière Hospitalcollaborator
Study Sites (6)
CHU Angers
Angers, 49100, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
CHU Limoges
Limoges, 87042, France
CHU Nancy
Nancy, 54511, France
CHU Nantes
Nantes, 44000, France
AP-HP La Pitié Salpétrière
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2019
First Posted
August 12, 2019
Study Start
February 5, 2020
Primary Completion
June 24, 2020
Study Completion
June 24, 2020
Last Updated
August 7, 2020
Record last verified: 2020-08