Determinants of Thyroid Surgery Outcomes (CATHY)

June 24, 2016 updated by: Hospices Civils de Lyon

Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Participation refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroid surgery
All patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion.
Procedure: Thyroid surgery
Thyroidectomies performed by all surgeons in 5 academic hospitals in France.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jean-Christophe Lifante, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D50528

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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