NCT02813733

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

June 22, 2016

Last Update Submit

June 24, 2016

Conditions

Thyroid Disease

Keywords

thyroid surgerysurgical outcomespatient safetyhealthcare qualitysurgeons performance

Outcome Measures

Primary Outcomes (1)

  • Recurrent laryngeal nerve palsy

    Systematic postoperative screening by laryngoscopy

    During inpatient stay and at 6 months following surgery

Secondary Outcomes (1)

  • Secondary hypoparathyroidism

    During inpatient stay and at 6 months following surgery

Study Arms (1)

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

Thyroid surgeryPROCEDURE

Thyroidectomies performed by all surgeons in 5 academic hospitals in France.

Thyroid surgery

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • \- Participation refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Jean-Christophe Lifante

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 27, 2016

Study Start

April 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)