Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

Recruiting

• Conditions: Thyroid; Laryngeal Injury; Endocrine Procedural Complications; Parathyroid; Deficiency

• Registration Number: NCT03309384
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-03-20
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-03-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraoperative parathormone values	intraoperative	parathormone in pg/mL

Secondary Outcome Measures

Name	Time	Method
postoperative hypocalcemia	within 1 week after thyroidectomy	calcium in mg/L
permanent postoperative hypoparathyroidism	at one year after thyroidectomy	parathormone in pg/mL
postoperative hypoparathyroidism	within 1 week after thyroidectomy	parathormone in pg/mL
laryngeal nerve palsy	at one year after thyroidectomy	laryngoscopy (normal / palsy)
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 hypocalcemia	at one year after thyroidectomy	calcium in mg/L

Trial Locations

Locations (1)

CHU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France