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PARACAL: Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03309384
Collaborator
(none)
1,000
Enrollment
1
Location
120
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
    Study Start Date :
    Mar 20, 2016
    Anticipated Primary Completion Date :
    Mar 20, 2026
    Anticipated Study Completion Date :
    Mar 20, 2026

    Outcome Measures

    Primary Outcome Measures

    1. intraoperative parathormone values [intraoperative]

      parathormone in pg/mL

    Secondary Outcome Measures

    1. postoperative hypocalcemia [within 1 week after thyroidectomy]

      calcium in mg/L

    2. postoperative hypoparathyroidism [within 1 week after thyroidectomy]

      parathormone in pg/mL

    3. permanent postoperative hypocalcemia [at one year after thyroidectomy]

      calcium in mg/L

    4. permanent postoperative hypoparathyroidism [at one year after thyroidectomy]

      parathormone in pg/mL

    5. laryngeal nerve palsy [during thyroidectomy]

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

    6. laryngeal nerve palsy [within 1 week after thyroidectomy]

      laryngoscopy (normal / palsy)

    7. laryngeal nerve palsy [at one year after thyroidectomy]

      laryngoscopy (normal / palsy)

    8. Postoperative complications other than outcomes from 1 to 8 [at one year after thyroidectomy]

      Postoperative morbidity classification (using a Clavien-Dindo classification) postoperatively

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
    Exclusion Criteria:
    • refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Nancy Vandœuvre-lès-Nancy France 54511

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Brunaud, CHU Nancy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laurent BRUNAUD, Professor of Surgery, MD, PhD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT03309384
    Other Study ID Numbers:
    • PARACAL
    • R2016-25
    First Posted:
    Oct 13, 2017
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypoparathyroidism
    Postoperative Complications

    Study Results

    No Results Posted as of Jan 12, 2022