Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)

Study Overview
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Brief Summary
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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.

Detailed Description
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Persistent hypoparathyroidism is an underestimate but major complication of total thyroidectomy. In this retrospective, observational, multicentre study, 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. Patients in six centers in France (Angers, Le Mans, Limoges, Nancy, Nantes, la Pitié-Salpétrière) and in the association Hypoparathyroïdisme France were contacted by mail. The primary endpoint was the mental health. The physic and global quality of life scores were assessed as secondary endpoints. Medical and VHI surveys were also send to the patients. The voice quality, the cardiovascular risk, the kidney function and the incidence of urinary lithiasis were also evaluated.

Official Title
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Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

Conditions
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Hypoparathyroidism, Quality of Life

Intervention / Treatment
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* Other: Non-interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypoparathyroid patients<br>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. | Other: Non-interventional study<br>* Non-interventional study<br>|
| Control patients, without hypoparathyroidism<br> | Other: Non-interventional study<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical quality score | Items from the SF36 (Short Form 36) survey | Through study completion, an average of 1 year | 
| Global quality of life score | Items from the SF36 (Short Form 36) survey | Through study completion, an average of 1 year | 
| Voice quality | Items from the VHI (Voice Handicap Index) survey | Through study completion, an average of 1 year | 
| Renal function quality | Serum creatinine and clearance dosage | Through study completion, an average of 1 year | 
| Presence of urinary lithiasis | Serum creatinine and clearance dosage | Through study completion, an average of 1 year | 
| Presence of cardiovascular complications | Defined as ischemic cardiopathy | Through study completion, an average of 1 year |