Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05642741 |
Other study ID # |
RC22_0495 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 2, 2023 |
Est. completion date |
January 21, 2026 |
Study information
Verified date |
August 2023 |
Source |
Nantes University Hospital |
Contact |
Eric MIRALLIE |
Phone |
+33 240083022 |
Email |
Eric.mirallie[@]chu-nantes.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to evaluate, for patients with post-thyroidectomy hypoparathyroidism
(HoPT), the severity of their HoPT and to validate clinical scores from a self-administered
questionnaire related to this disease (questionnaire which evaluates the severity of clinical
symptoms related to HoPT and their impact on quality of life) in order to assess the severity
of HoPT and to optimize support.
Description:
Total thyroidectomy is a procedure very frequently performed in France (and worldwide. Around
35,000 patients are operated on each year in France. Among its complications,
hypoparathyroidism (HoPT) results from a suppression or a significant decrease of parathyroid
hormone (PTH) secretion leading to hypocalcemia associated with urinary calcium leakage.
The frequency of definitive HoPT (at least 6 months postoperative) varies from 1 to 10%
(Sitges-Serra et al. Br J Surg, 2010, Duclos BMJ 2012). It is often underestimated by
operators (Cho et al. Endocr Pract, 2014). Our team has previously shown that this HoPT is
responsible for a significant impairment in quality of life (mental and physical) and voice
(Frey et al. Ann Surg, 2021).
Despite the existence of treatment guidelines, only 26 to 32% of patients in French series
are treated according to international recommendations (Bertocchio et al. Endocr Connect,
2022). It is therefore important to be able to assess the severity of HoPT and to validate a
clinical score using a self-administered questionnaire related to this disease (questionnaire
which assesses the severity of the clinical symptoms linked to HoPT and their impact on the
quality of life).
Only patients with post-thyroidectomy HoPT will be included in the present study. Patients
who underwent total thyroidectomy in the department of Loire-Atlantique will be prospectively
included if they display post-operative HoPT. In addition, HoPT patients previously operated
on and followed up in Loire-Atlantique, as well as patients from the "Hypoparathyroidisme
France" association (https://hypopara.fr) and HoPT patients who have been included in the
ThyrQol and Fothyr studies (MiralliƩ et al. Eur J Endocrinol, 2020, Blanchard et al. BJS
Open, 2017) will also be included.The data collected will be routine biological data (usual
blood and urine tests), responses to the SF36 questionnaire (validated quality of life
questionnaire) and responses to a questionnaire that will assess the frequency and impact on
the daily life of the symptoms reported by these patients. This questionnaire contains items
related with symptoms that are frequently displayed by these patients and that are
responsible for an impaired quality of life, in accordance with the data of the literature,
our previous study (Frey et al. Ann Surg, 2021) and a discussion with the members of the
association Hypoparathyroidism France.