Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy (PARACAL)

February 11, 2025 updated by: Laurent BRUNAUD, Central Hospital, Nancy, France

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for total thyroidectomy in university of Nancy (University Hospital)

Description

Inclusion Criteria:

  • patients scheduled for total thyroidectomy in university of Nancy (University Hospital)

Exclusion Criteria:

  • refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative parathormone values
Time Frame: intraoperative
parathormone in pg/mL
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative hypocalcemia
Time Frame: within 1 week after thyroidectomy
calcium in mg/L
within 1 week after thyroidectomy
postoperative hypoparathyroidism
Time Frame: within 1 week after thyroidectomy
parathormone in pg/mL
within 1 week after thyroidectomy
permanent postoperative hypocalcemia
Time Frame: at one year after thyroidectomy
calcium in mg/L
at one year after thyroidectomy
permanent postoperative hypoparathyroidism
Time Frame: at one year after thyroidectomy
parathormone in pg/mL
at one year after thyroidectomy
laryngeal nerve palsy
Time Frame: during thyroidectomy
continuous intraoperative neuromonitoring (> 50% baseline values yes/no)
during thyroidectomy
laryngeal nerve palsy
Time Frame: within 1 week after thyroidectomy
laryngoscopy (normal / palsy)
within 1 week after thyroidectomy
laryngeal nerve palsy
Time Frame: at one year after thyroidectomy
laryngoscopy (normal / palsy)
at one year after thyroidectomy
Postoperative complications other than outcomes from 1 to 8
Time Frame: at one year after thyroidectomy
Postoperative morbidity classification (using a Clavien-Dindo classification) postoperatively
at one year after thyroidectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Brunaud, CHU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 20, 2016

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

March 20, 2026

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARACAL
  • R2016-25 (Registry Identifier: CNIL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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