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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Quality of Life; Hypoparathyroidism

Treatments: Other: Non-interventional study

Study type: Observational

Funder types: Other

Identifiers

NCT04053647

RC19_0021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

143 participants in 2 patient groups

Hypoparathyroid patients

Description:

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.

Treatment:

Other: Non-interventional study

Control patients, without hypoparathyroidism

Treatment:

Other: Non-interventional study