NCT03309384

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

10 years

First QC Date

September 6, 2017

Last Update Submit

February 11, 2025

Conditions

Endocrine Procedural ComplicationsThyroidParathyroid; DeficiencyLaryngeal Injury

Outcome Measures

Primary Outcomes (1)

  • intraoperative parathormone values

    parathormone in pg/mL

    intraoperative

Secondary Outcomes (8)

  • postoperative hypocalcemia

    within 1 week after thyroidectomy

  • postoperative hypoparathyroidism

    within 1 week after thyroidectomy

  • permanent postoperative hypocalcemia

    at one year after thyroidectomy

  • permanent postoperative hypoparathyroidism

    at one year after thyroidectomy

  • laryngeal nerve palsy

    during thyroidectomy

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Thyroid DiseasesHypoparathyroidism

Condition Hierarchy (Ancestors)

Endocrine System DiseasesParathyroid Diseases

Study Officials

  • Brunaud

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brunaud

CONTACT

l.brunaud@chru-nancy.fr

Jacquel

CONTACT

s.jacquel@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, MD, PhD

Study Record Dates

First Submitted

September 6, 2017

First Posted

October 13, 2017

Study Start

March 20, 2016

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

FR(1)