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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Hypoparathyroidism
• Intervention / Treatment: Other: Non-interventional study

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.

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Limoges, France, 87042
    • CHU Limoges
  • Nancy, France, 54511
    • CHU Nancy
  • Nantes, France, 44000
    • CHU Nantes
  • Paris, France, 75013
    • AP-HP La Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypoparathyroid patients; 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.	Other: Non-interventional study; Non-interventional study
Control patients, without hypoparathyroidism	Other: Non-interventional study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: University Hospital, Angers; Central Hospital, Nancy, France; University Hospital, Limoges; Pitié-Salpêtrière Hospital; Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: RC19_0021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No