Endocrine Procedural ComplicationsPARACALNCT03309384
Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy
An observational study of Endocrine Procedural Complications and Thyroid, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endocrine Procedural Complications, Thyroid, Parathyroid; Deficiency
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2016to 19 Oct 2026
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Who may be able to join
- patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.
Read the detailed description
Intraoperative PTH values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy.
Postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively.
Other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.
- Medical subject headings
- Thyroid Diseases, Hypoparathyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative parathormone values
parathormone in pg/mL
Measured: intraoperative
Secondary outcomes (8)
postoperative hypocalcemia
calcium in mg/L
Measured: within 1 week after thyroidectomy
postoperative hypoparathyroidism
parathormone in pg/mL
Measured: within 1 week after thyroidectomy
permanent postoperative hypocalcemia
calcium in mg/L
Measured: at one year after thyroidectomy
permanent postoperative hypoparathyroidism
parathormone in pg/mL
Measured: at one year after thyroidectomy
laryngeal nerve palsy
continuous intraoperative neuromonitoring (> 50% baseline values yes/no)
Measured: during thyroidectomy
laryngeal nerve palsy
laryngoscopy (normal / palsy)
Measured: within 1 week after thyroidectomy
laryngeal nerve palsy
laryngoscopy (normal / palsy)
Measured: at one year after thyroidectomy
Postoperative complications other than outcomes from 1 to 8
Postoperative morbidity classification (using a Clavien-Dindo classification) postoperatively
Measured: at one year after thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start20 Mar 2016
- Primary completion19 Oct 2026
- Study completion19 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine Procedural ComplicationsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent BRUNAUD, Central Hospital, Nancy, France
- Investigators
- Brunaud, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309384
- Sponsor's protocol ID
- PARACAL
- Other IDs
- R2016-25
- Acronym
- PARACAL
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT03309384
- Acronym / sponsor ID
- PARACAL / PARACAL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Mar 2016
- Primary completion
- 19 Oct 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 13 Oct 2017 (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 goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.
Detailed description
Intraoperative PTH values and intraoperative continuous neuromonitoring will be collected prospectively in consecutive patients who undergo total thyroidectomy.
Postoperative parathyroid morbidity and recurrent laryngeal nerve morbidity will be evaluated within 1 week after total thyroidectomy and at 1 year postoperatively.
Other postoperative morbidity will be evaluated at 1 year postoperatively using validated classification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Key inclusion criteria (1 listed)
- patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraoperative parathormone values
Time frame: intraoperative
parathormone in pg/mL
8 secondary outcomes
postoperative hypocalcemia
Time frame: within 1 week after thyroidectomy
postoperative hypoparathyroidism
Time frame: within 1 week after thyroidectomy
permanent postoperative hypocalcemia
Time frame: at one year after thyroidectomy
permanent postoperative hypoparathyroidism
Time frame: at one year after thyroidectomy
laryngeal nerve palsy
Time frame: during thyroidectomy
laryngeal nerve palsy
Time frame: within 1 week after thyroidectomy
laryngeal nerve palsy
Time frame: at one year after thyroidectomy
Postoperative complications other than outcomes from 1 to 8
Time frame: at one year after thyroidectomy
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 20 Oct 2026.
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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.
Brunaud principal investigator
Central Hospital, Nancy, France
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 Endocrine Procedural Complications and Thyroid, run by Central Hospital, Nancy, France 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 1 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 20 Oct 2026. 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?
intraoperative parathormone values (time frame: intraoperative). 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 20 Oct 2026.