Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)
- Conditions
- Quality of LifeHypoparathyroidism
- Interventions
- Other: Non-interventional study
- Registration Number
- NCT04053647
- Lead Sponsor
- Nantes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hypoparathyroid patients Non-interventional study 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 Non-interventional study -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Physical quality score Through study completion, an average of 1 year Items from the SF36 (Short Form 36) survey
Renal function quality Through study completion, an average of 1 year Serum creatinine and clearance dosage
Presence of urinary lithiasis Through study completion, an average of 1 year Serum creatinine and clearance dosage
Voice quality Through study completion, an average of 1 year Items from the VHI (Voice Handicap Index) survey
Global quality of life score Through study completion, an average of 1 year Items from the SF36 (Short Form 36) survey
Presence of cardiovascular complications Through study completion, an average of 1 year Defined as ischemic cardiopathy
Trial Locations
- Locations (6)
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
CHU Angers
🇫🇷Angers, France
CHU Limoges
🇫🇷Limoges, France
CHU Nancy
🇫🇷Nancy, France
CHU Nantes
🇫🇷Nantes, France
AP-HP La Pitié Salpétrière
🇫🇷Paris, France