Hypoparathyroidism, Quality of Life
Conditions
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.
Detailed description
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.
Interventions
OTHERNon-interventional study
Non-interventional study
Sponsors
University Hospital, Angers
Centre Hospitalier le Mans
University Hospital, Limoges
Central Hospital, Nancy, France
Pitié-Salpêtrière Hospital
Nantes University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental health | Through study completion, an average of 1 year | Items from mental quality of life score defined by the SF36 (Short Form 36) survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global quality of life score | Through study completion, an average of 1 year | Items from the SF36 (Short Form 36) survey |
| Voice quality | Through study completion, an average of 1 year | Items from the VHI (Voice Handicap Index) survey |
| Physical quality score | Through study completion, an average of 1 year | Items from the SF36 (Short Form 36) survey |
| Presence of urinary lithiasis | Through study completion, an average of 1 year | Serum creatinine and clearance dosage |
| Presence of cardiovascular complications | Through study completion, an average of 1 year | Defined as ischemic cardiopathy |
| Renal function quality | Through study completion, an average of 1 year | Serum creatinine and clearance dosage |
Countries
France
Outcome results
None listed