ThyroidectomySEV-HYPOPARANCT05642741
Validation of a Hypoparathyroidism Self-questionnaire
An observational study of Thyroidectomy and Hypoparathyroidism Postprocedural, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroidectomy, Hypoparathyroidism Postprocedural
- What is being tested?
- Response to medical and research questionnaires
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 10 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients who have undergone total thyroidectomy and who have definitive hypoparathyroidism
Who may be able to join
- Major patient
- Patients undergoing total thyroidectomy
- Patients with permanent hypoparathyroidism defined by a parathyroid hormone concentration ≤ 25 pg/mL more than 6 months after surgery and who require vitamin and calcium therapy.
- Not being opposed to participating in the study (questionnaires will be sent with the study information note. If the patient returns the questionnaires: we will consider that he/she is not opposed to participate in this study)
- Participants must be affiliated to a social security system
Who cannot join
- Pregnant women when filling out questionnaires (the child's parathyroids can correct the mother's hypoparathyroidism)
- Minors or protected patients (under guardianship)
- Patients under court protection
- Patients on long-term vitamin-calcium therapy after total thyroidectomy whose PTH concentration has not been controlled or whose concentration is higher than 25 pg/mL.
- Hypoparathyroid patients of other origin than post-thyroidectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Self-questionnaire to Assess the Severity of Clinical Symptoms Related to Post-thyroidectomy Hypoparathyroidism
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.
Read the detailed 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 (Mirallié 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.
- Conditions
- Thyroidectomy, Hypoparathyroidism Postprocedural
- Being tested
- Response to medical and research questionnaires
- Keywords
- Total thyroidectomy, Hypoparathyroidism Postprocedural, Quality of life, Self-questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response to medical and research questionnairesOther
Patients will receive by mail or email the study information note, the medical questionnaire, the SF36 and the research questionnaire to be completed (then again 3 weeks later). The patients will return the questionnaires by mail or by post.
| Study group | Role | What they receive |
|---|---|---|
| Hypoparathyroidism after total thyroidectomy | Adult patients definitive post-thyroidectomy HoPT defined by a parathyroid hormone (PTH) concentration ≤ 25 pg/mL more than 6 months after the operation and who require treatment with vitamin D and/or calcium supplementation. Each patient will complete a questionnaire twice (3 weeks apart +/- 7 days). The questionnaire, which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life, is adapted to this pathology. Receives: Other: Response to medical and research questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate two clinical scores (a symptom importance score and a symptom impact score in daily life) from a questionnaire adapted to hypoparathyroidism, in order to better assess the severity of HoPT and optimize management.
To psychometrically validate the two scores created with the hypoparathyroidism severity questionnaire by showing, on the one hand, a good fit to a confirmatory two-dimensional factorial model (RSMEA<0.08 and CFI>0.9) and, on the other hand, by showing the good internal consistency of each of the scores (Cronbach's alpha >0.7).
Measured: 3 weeks
Secondary outcomes (3)
Discriminant validation : correlate hypoparathyroidism severity scores with biological results (PTH, calcemia, calciuria)
Discriminant validation: Spearman correlation coefficients between hypoparathyroidism severity questionnaire scores and biological results. Moderately strong values are expected (>0.4 in absolute value)
Measured: 3 weeks
Concurrent validation of scores: correlate hypoparathyroidism severity scores with patients' quality of life scores (SF36)
Concurrent validation: Spearman correlation coefficients between hypoparathyroidism severity scores and SF36 quality of life scores. Negative correlations are expected (<-0.4)
Measured: 3 weeks
Reproducibility of scores: show stability of scores at 3 week intervals (+/- 7 days)
Reproducibility: Intraclass correlation coefficients between the hypoparathyroidism severity scores obtained at two closely spaced questionnaire administrations (3 weeks apart +/- 1 week)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start2 May 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation SantéDige, Association Francophone de Chirurgie Endocrinienne (AFCE)
- Responsible party
- Sponsor
- Investigators
- Eric MIRALLIE, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642741
- Sponsor's protocol ID
- RC22_0495
- Acronym
- SEV-HYPOPARA
- Status last verified
- Sep 2024
- First submitted
- 30 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Self-questionnaire to Assess the Severity of Clinical Symptoms Related to Post-thyroidectomy Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT05642741
- Acronym / sponsor ID
- SEV-HYPOPARA / RC22_0495
- Conditions
- Thyroidectomy, Hypoparathyroidism Postprocedural
- Keywords
- Total thyroidectomy, Hypoparathyroidism Postprocedural, Quality of life, Self-questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation SantéDige, Association Francophone de Chirurgie Endocrinienne (AFCE)
- Study start
- 2 May 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 (Mirallié 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoparathyroidism after total thyroidectomy | – | Other: Response to medical and research questionnairesAdult patients definitive post-thyroidectomy HoPT defined by a parathyroid hormone (PTH) concentration ≤ 25 pg/mL more than 6 months after the operation and who require treatment with vitamin D and/or calcium supplementation. Each patient will complete a questionnaire twice (3 weeks apart +/- 7 days). The questionnaire, which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life, is adapted to this pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients who have undergone total thyroidectomy and who have definitive hypoparathyroidism
Key inclusion criteria (5 listed)
- Major patient
- Patients undergoing total thyroidectomy
- Patients with permanent hypoparathyroidism defined by a parathyroid hormone concentration ≤ 25 pg/mL more than 6 months after surgery and who require vitamin and calcium therapy.
- Not being opposed to participating in the study (questionnaires will be sent with the study information note. If the patient returns the questionnaires: we will consider that he/she is not opposed to participate in this study)
- Participants must be affiliated to a social security system
Key exclusion criteria (5 listed)
- Pregnant women when filling out questionnaires (the child's parathyroids can correct the mother's hypoparathyroidism)
- Minors or protected patients (under guardianship)
- Patients under court protection
- Patients on long-term vitamin-calcium therapy after total thyroidectomy whose PTH concentration has not been controlled or whose concentration is higher than 25 pg/mL.
- Hypoparathyroid patients of other origin than post-thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response to medical and research questionnairesPatients will receive by mail or email the study information note, the medical questionnaire, the SF36 and the research questionnaire to be completed (then again 3 weeks later). The patients will return the questionnaires by mail or by post. | Other | Hypoparathyroidism after total thyroidectomy |
Primary outcome
Validate two clinical scores (a symptom importance score and a symptom impact score in daily life) from a questionnaire adapted to hypoparathyroidism, in order to better assess the severity of HoPT and optimize management.
Time frame: 3 weeks
To psychometrically validate the two scores created with the hypoparathyroidism severity questionnaire by showing, on the one hand, a good fit to a confirmatory two-dimensional factorial model (RSMEA<0.08 and CFI>0.9) and, on the other hand, by showing the good internal consistency of each of the scores (Cronbach's alpha >0.7).
3 secondary outcomes
Discriminant validation : correlate hypoparathyroidism severity scores with biological results (PTH, calcemia, calciuria)
Time frame: 3 weeks
Concurrent validation of scores: correlate hypoparathyroidism severity scores with patients' quality of life scores (SF36)
Time frame: 3 weeks
Reproducibility of scores: show stability of scores at 3 week intervals (+/- 7 days)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric MIRALLIE principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroidectomy and Hypoparathyroidism Postprocedural, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate two clinical scores (a symptom importance score and a symptom impact score in daily life) from a questionnaire adapted to hypoparathyroidism, in order to better assess the severity of HoPT and optimize management. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.