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
|Condition or disease|
|Endocrine Procedural Complications Thyroid Parathyroid; Deficiency Laryngeal Injury|
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 [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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|
- intraoperative parathormone values [ Time Frame: intraoperative ]parathormone in pg/mL
- postoperative hypocalcemia [ Time Frame: within 1 week after thyroidectomy ]calcium in mg/L
- postoperative hypoparathyroidism [ Time Frame: within 1 week after thyroidectomy ]parathormone in pg/mL
- permanent postoperative hypocalcemia [ Time Frame: at one year after thyroidectomy ]calcium in mg/L
- permanent postoperative hypoparathyroidism [ Time Frame: at one year after thyroidectomy ]parathormone in pg/mL
- laryngeal nerve palsy [ Time Frame: during thyroidectomy ]continuous intraoperative neuromonitoring (> 50% baseline values yes/no)
- laryngeal nerve palsy [ Time Frame: within 1 week after thyroidectomy ]laryngoscopy (normal / palsy)
- laryngeal nerve palsy [ Time Frame: at one year after thyroidectomy ]laryngoscopy (normal / palsy)
- 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
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
|Vandœuvre-lès-Nancy, France, 54511|
|Contact: laurent Brunaud email@example.com|
|Principal Investigator:||Brunaud||CHU Nancy|