Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03309384

Acronym

PARACAL

Enrollment

1000

Registered

2017-10-13

Start date

2016-03-20

Completion date

2026-03-20

Last updated

2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine Procedural Complications, Laryngeal Injury, Parathyroid; Deficiency, Thyroid

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* refusal to participate

Design outcomes

Primary

Measure	Time frame	Description
intraoperative parathormone values	intraoperative	parathormone in pg/mL

Secondary

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

Countries

France

Contacts

Primary ContactBrunaud

l.brunaud@chru-nancy.fr

Backup ContactJacquel

s.jacquel@chru-nancy.fr

Outcome results