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Determinants of Thyroid Surgery Outcomes (CATHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813733
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Thyroid Disease Procedure: Thyroid surgery

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Study Type : Observational
Actual Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

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.




Primary Outcome Measures :
  1. Recurrent laryngeal nerve palsy [ Time Frame: During inpatient stay and at 6 months following surgery ]
    Systematic postoperative screening by laryngoscopy


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Participation refusal


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813733


Locations
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France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jean-Christophe Lifante Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02813733    
Other Study ID Numbers: D50528
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Keywords provided by Hospices Civils de Lyon:
thyroid surgery
surgical outcomes
patient safety
healthcare quality
surgeons performance
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases