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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053647
• Other study ID #: RC19_0021
• Status: Completed
• Start date: February 5, 2020
• Est. completion date: June 24, 2020

Study information

• Verified date: August 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoparathyroidism
• Quality of Life

Intervention

Other:
• Non-interventional study
Non-interventional study

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Centre Hospitalier Le Mans	Le Mans
France	CHU Limoges	Limoges
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	AP-HP La Pitié Salpétrière	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Nantes University Hospital	Centre Hospitalier le Mans, Nancy University Hospital, Pitié-Salpêtrière Hospital, University Hospital, Angers, University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

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