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Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy (PARACAL)

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ClinicalTrials.gov Identifier: NCT03309384
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Laurent BRUNAUD, Central Hospital, Nancy, France

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
Endocrine Procedural Complications Thyroid Parathyroid; Deficiency Laryngeal Injury

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy
Study Start Date : March 20, 2016
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : March 20, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery




Primary Outcome Measures :
  1. intraoperative parathormone values [ Time Frame: intraoperative ]
    parathormone in pg/mL


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients scheduled for total thyroidectomy in university of Nancy (University Hospital)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • refusal to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309384


Contacts
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Contact: Brunaud l.brunaud@chu-nancy.fr

Locations
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France
CHU Nancy Recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: laurent Brunaud       l.brunaud@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Brunaud CHU Nancy
Additional Information:

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Responsible Party: Laurent BRUNAUD, Professor of Surgery, MD, PhD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03309384    
Other Study ID Numbers: PARACAL
R2016-25 ( Registry Identifier: CNIL )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoparathyroidism
Postoperative Complications
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases