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NCT Number: NCT03309384

Intraoperative Monitoring to Predict Postoperative Complications After 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.

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Key information

Conditions

Endocrine Procedural Complications Endocrine System Diseases Hypoparathyroidism Laryngeal Injury Parathyroid Diseases Parathyroid; Deficiency Thyroid Thyroid Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location status: Recruiting

Location contact

laurent Brunaud

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • refusal to participate

Treatment and study plan

Primary outcomes

  1. intraoperative parathormone values

    Time frame: intraoperative

    parathormone in pg/mL

Secondary outcomes

  1. postoperative hypocalcemia

    Time frame: within 1 week after thyroidectomy

    calcium in mg/L

  2. postoperative hypoparathyroidism

    Time frame: within 1 week after thyroidectomy

    parathormone in pg/mL

  3. permanent postoperative hypocalcemia

    Time frame: at one year after thyroidectomy

    calcium in mg/L

  4. permanent postoperative hypoparathyroidism

    Time frame: at one year after thyroidectomy

    parathormone in pg/mL

  5. laryngeal nerve palsy

    Time frame: during thyroidectomy

    continuous intraoperative neuromonitoring (> 50% baseline values yes/no)

  6. laryngeal nerve palsy

    Time frame: within 1 week after thyroidectomy

    laryngoscopy (normal / palsy)

  7. laryngeal nerve palsy

    Time frame: at one year after thyroidectomy

    laryngoscopy (normal / palsy)

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Brunaud

CONTACT

[email protected]

Jacquel

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy

Acronym: PARACAL

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2017
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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