Clinical trial NCT04053647: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy (Qol-Hypopara)
Official title: Quality of Life Evaluation (SF-36) in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Quality of Life
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: Centre Hospitalier le Mans
name: University Hospital, Limoges
name: Central Hospital, Nancy, France
name: Pitié-Salpêtrière Hospital
First posted: 2019-08-12
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mental health
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Physical quality score
timeFrame: Through study completion, an average of 1 year
measure: Global quality of life score
timeFrame: Through study completion, an average of 1 year
measure: Voice quality
timeFrame: Through study completion, an average of 1 year
measure: Renal function quality
timeFrame: Through study completion, an average of 1 year
measure: Presence of urinary lithiasis
timeFrame: Through study completion, an average of 1 year
measure: Presence of cardiovascular complications
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Limoges
country: France
facility: CHU Limoges
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP La Pitié Salpétrière
Study officials:
References: