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NCT Number: NCT04053647

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Mental health

    Time frame: Through study completion, an average of 1 year

    Items from mental quality of life score defined by the SF36 (Short Form 36) survey

Secondary outcomes

  1. Physical quality score

    Time frame: Through study completion, an average of 1 year

    Items from the SF36 (Short Form 36) survey

  2. Global quality of life score

    Time frame: Through study completion, an average of 1 year

    Items from the SF36 (Short Form 36) survey

  3. Voice quality

    Time frame: Through study completion, an average of 1 year

    Items from the VHI (Voice Handicap Index) survey

  4. Renal function quality

    Time frame: Through study completion, an average of 1 year

    Serum creatinine and clearance dosage

  5. Presence of urinary lithiasis

    Time frame: Through study completion, an average of 1 year

    Serum creatinine and clearance dosage

  6. Presence of cardiovascular complications

    Time frame: Through study completion, an average of 1 year

    Defined as ischemic cardiopathy

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Central Hospital, Nancy, France
  • Centre Hospitalier le Mans
  • Pitié-Salpêtrière Hospital
  • University Hospital, Angers
  • University Hospital, Limoges

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2019
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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