Intraoperative Monitoring to Predict Postoperative Compli... | NCT03309384

Studies
Intraoperative Monitoring to Predict Postoperative Complications After Thyroidectomy

NCT03309384

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Feb 12, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Endocrine Procedural Complications
Thyroid
Parathyroid; Deficiency
Laryngeal Injury

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R2016-25	Registry Identifier	CNIL

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2016

Primary Completion Date

Mar 20, 2026Estimated

Completion Date

Mar 20, 2026Estimated

First Submitted Date

Sep 6, 2017

First Submission Date that Met QC Criteria

Oct 12, 2017

First Posted Date

Oct 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2025

Last Update Posted Date

Feb 12, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurent BRUNAUD, Professor of Surgery, MD, PhD, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
postoperative hypocalcemia	calcium in mg/L	within 1 week after thyroidectomy
postoperative hypoparathyroidism	parathormone in pg/mL

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brunaud	Contact			l.brunaud@chru-nancy.fr
Jacquel	Contact			s.jacquel@chru-nancy.fr

Overall Officials

Name	Affiliation	Role
Brunaud	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Nancy	Recruiting	Vandœuvre-lès-Nancy		54511	France

Condition Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases
D007011	Hypoparathyroidism

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases
D010279	Parathyroid Diseases

Browse Leaves

Not provided

Browse Branches

Not provided