Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

Thyroid Clinical Trial

— PARACAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309384
• Other study ID #: PARACAL
• Secondary ID: R2016-25
• Status: Recruiting
• Start date: March 20, 2016
• Est. completion date: March 20, 2026

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: Brunaud
• Email: l.brunaud[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 20, 2026
• Est. primary completion date: March 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Endocrine Procedural Complications
• Hypoparathyroidism
• Laryngeal Injury
• Parathyroid; Deficiency
• Postoperative Complications
• Thyroid

Locations

Country	Name	City	State
France	CHU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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