Determinants of Thyroid Surgery Outcomes | NCT02813733

Studies
Determinants of Thyroid Surgery Outcomes

NCT02813733

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Jun 27, 2016Estimated

Enrollment

3,500Actual

Phase

Not provided

Conditions

Thyroid Disease

Interventions

Thyroid surgery

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

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 24, 2016

First Posted Date

Jun 27, 2016Estimated

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

Jun 24, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. For this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thyroid surgery		All patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion.	Procedure: Thyroid surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyroid surgery	Procedure	Thyroidectomies performed by all surgeons in 5 academic hospitals in France.	Thyroid surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrent laryngeal nerve palsy	Systematic postoperative screening by laryngoscopy	During inpatient stay and at 6 months following surgery

Secondary Outcomes

Measure	Description	Time Frame
Secondary hypoparathyroidism	Systematic postoperative screening based on hypocalcaemia < 2 mmoL/l or vitaminocalcic substitution	During inpatient stay and at 6 months following surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All patients who underwent a thyroid procedure between April 2008 and July 2008.

Exclusion Criteria:

- Participation refusal

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 who underwent a thyroid procedure during study period in 5 high volume referral centers in France were eligible for inclusion.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Christophe Lifante	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet		Pierre-Bénite		69310	France

Condition Browse Module

MeSH Terms

ID	Term
D013959	Thyroid Diseases

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided