Determinants of Thyroid Surgery Outcomes

Thyroid Disease Clinical Trial

— CATHY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813733
• Other study ID #: D50528
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: June 24, 2016
• Start date: April 2008
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: January 2016
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Participation refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thyroid Disease
• Thyroid Diseases

Intervention

Procedure:
• Thyroid surgery
Thyroidectomies performed by all surgeons in 5 academic hospitals in France.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent laryngeal nerve palsy	Systematic postoperative screening by laryngoscopy	During inpatient stay and at 6 months following surgery	No
Secondary	Secondary hypoparathyroidism	Systematic postoperative screening based on hypocalcaemia < 2 mmoL/l or vitaminocalcic substitution	During inpatient stay and at 6 months following surgery	No