HypoparathyroidismNCT04372225
Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy
An observational study of Hypoparathyroidism, run by Aix Marseille Université at 1 site in France.
Trial summary
With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- analysis of hypocalcemia
- How many people
- 477 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2020to 25 Apr 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Analysis of calcium and PTH levels in postoperative day 1
Who may be able to join
- Total thyroidectomy
Who cannot join
- concomitant parathyroidectomy for primary hyperparathyroidism
- lobectomy only
- completion thyroidectomy
- central and lateral neck dissection
- patients with calcium and/or vitamin D supplementation prior surgery
- patients with known and significant osteoporosis and renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?
With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.
The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.
Read the detailed description
Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.
We also analyze post-operative complications.
- Conditions
- Hypoparathyroidism
- Being tested
- analysis of hypocalcemia
- Keywords
- thyroidectomy, hypocalcemia, hypoparathyroidism, discharge, PTH
- Medical subject headings
- Hypoparathyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of hypocalcemiaOther
analysis of postoperative calcium and PTH levels
| Study group | Role | What they receive |
|---|---|---|
| 477 patients | the biological tests of 477 patients undergoing total thyroidectomy were analyzed Receives: Other: analysis of hypocalcemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcium and PTH thresholds
For all 477 patients postoperative calcium and PTH levels and treatment with calcium and vitamin D will be analyzed.
Objective is to identify the calcium and PTH thresholds at which the patient after total thyroidectomy can be discharged without risk of hypocalcemia.
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start25 Apr 2020
- Primary completion25 Apr 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoparathyroidismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aix Marseille Université
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paladino Nunzia Cinzia, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372225
- Sponsor's protocol ID
- ArixMU
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data are confidential
Publications
Paladino NC, Guerin C, Graziani J, Morange I, Loundou A, Taieb D, Sebag F. Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study. Langenbecks Arch Surg. 2021 Nov;406(7):2425-2431. doi: 10.1007/s00423-021-02237-2. Epub 2021 Aug 10.
PubMed 34374848
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?
- ClinicalTrials.gov ID
- NCT04372225
- Acronym / sponsor ID
- ArixMU
- Conditions
- Hypoparathyroidism
- Keywords
- thyroidectomy, hypocalcemia, hypoparathyroidism, discharge, PTH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Aix Marseille UniversitéUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 1 May 2020 (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.
With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.
The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.
Detailed description
Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.
We also analyze post-operative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 477 patients | – | Other: analysis of hypocalcemiathe biological tests of 477 patients undergoing total thyroidectomy were analyzed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Analysis of calcium and PTH levels in postoperative day 1
Key inclusion criteria (1 listed)
- Total thyroidectomy
Key exclusion criteria (6 listed)
- concomitant parathyroidectomy for primary hyperparathyroidism
- lobectomy only
- completion thyroidectomy
- central and lateral neck dissection
- patients with calcium and/or vitamin D supplementation prior surgery
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 |
|---|---|---|
| analysis of hypocalcemiaanalysis of postoperative calcium and PTH levels | Other | 477 patients |
Primary outcome
calcium and PTH thresholds
Time frame: one years
For all 477 patients postoperative calcium and PTH levels and treatment with calcium and vitamin D will be analyzed. Objective is to identify the calcium and PTH thresholds at which the patient after total thyroidectomy can be discharged without risk of hypocalcemia.
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 1 May 2020.
- Derived from this study: PubMed 34374848Paladino NC, Guerin C, Graziani J, Morange I, Loundou A, Taieb D, Sebag F. Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study. Langenbecks Arch Surg. 2021 Nov;406(7):2425-2431. doi: 10.1007/s00423-021-02237-2. Epub 2021 Aug 10.
- Individual participant dataSharing planned: No. the data are confidential
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoparathyroidism, run by Aix Marseille Université 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 1 inclusion and 6 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 1 May 2020. 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?
calcium and PTH thresholds (time frame: one years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372225, which also lists 1 linked publication.
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 1 May 2020.