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RecruitingNCT03309384PARACALUpdated Feb 12, 2025

Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

An observational study in Endocrine Procedural Complications, Thyroid and Parathyroid; Deficiency, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endocrine Procedural Complications
  • Thyroid
  • Parathyroid; Deficiency
  • Laryngeal Injury
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • refusal to participate
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. intraoperative parathormone values

    parathormone in pg/mL

    Time frame: intraoperative

Secondary outcomes

  1. postoperative hypocalcemia

    calcium in mg/L

    Time frame: within 1 week after thyroidectomy

  2. postoperative hypoparathyroidism

    parathormone in pg/mL

    Time frame: within 1 week after thyroidectomy

  3. permanent postoperative hypocalcemia

    calcium in mg/L

    Time frame: at one year after thyroidectomy

  4. permanent postoperative hypoparathyroidism

    parathormone in pg/mL

    Time frame: at one year after thyroidectomy

  5. laryngeal nerve palsy

    continuous intraoperative neuromonitoring (\> 50% baseline values yes/no)

    Time frame: during thyroidectomy

  6. laryngeal nerve palsy

    laryngoscopy (normal / palsy)

    Time frame: within 1 week after thyroidectomy

  7. laryngeal nerve palsy

    laryngoscopy (normal / palsy)

    Time frame: at one year after thyroidectomy

  8. Postoperative complications other than outcomes from 1 to 8

    Postoperative morbidity classification (using a Clavien-Dindo classification) postoperatively

    Time frame: at one year after thyroidectomy

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03309384
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Laurent BRUNAUD (Professor of Surgery, MD, PhD, Central Hospital, Nancy, France) — Principal investigator
First posted
Oct 13, 2017
Start date
Mar 20, 2016
Primary completion
Mar 20, 2026 (estimated)
Completion
Mar 20, 2026 (estimated)
Last update
Feb 12, 2025

Study contacts

Brunaud
principal investigator · CHU Nancy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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