Thyroid DiseaseCATHYNCT02813733
Determinants of Thyroid Surgery Outcomes
An observational study of Thyroid Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- Thyroid surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- All patients who underwent a thyroid procedure between April 2008 and July 2008.
Who cannot join
- Participation refusal
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Pierre-Bénite, 69310
About this study
Official title: 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.
- Conditions
- Thyroid Disease
- Being tested
- Thyroid surgery
- Keywords
- thyroid surgery, surgical outcomes, patient safety, healthcare quality, surgeons performance
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid surgeryProcedure or surgery
Thyroidectomies performed by all surgeons in 5 academic hospitals in France.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid surgery | All patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion. Receives: Procedure: Thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent laryngeal nerve palsy
Systematic postoperative screening by laryngoscopy
Measured: During inpatient stay and at 6 months following surgery
Secondary outcomes (1)
Secondary hypoparathyroidism
Systematic postoperative screening based on hypocalcaemia < 2 mmoL/l or vitaminocalcic substitution
Measured: During inpatient stay and at 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Lifante, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813733
- Sponsor's protocol ID
- D50528
- Acronym
- CATHY
- Status last verified
- Jun 2016
- First submitted
- 22 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes
- ClinicalTrials.gov ID
- NCT02813733
- Acronym / sponsor ID
- CATHY / D50528
- Conditions
- Thyroid Disease
- Keywords
- thyroid surgery, surgical outcomes, patient safety, healthcare quality, surgeons performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid surgery | – | Procedure: Thyroid surgeryAll patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients who underwent a thyroid procedure between April 2008 and July 2008.
Key exclusion criteria (1 listed)
- Participation refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid surgeryThyroidectomies performed by all surgeons in 5 academic hospitals in France. | Procedure or surgery | Thyroid surgery |
Primary outcome
Recurrent laryngeal nerve palsy
Time frame: During inpatient stay and at 6 months following surgery
Systematic postoperative screening by laryngoscopy
1 secondary outcome
Secondary hypoparathyroidism
Time frame: During inpatient stay and at 6 months following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christophe Lifante principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent laryngeal nerve palsy (time frame: During inpatient stay and at 6 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016; AzTrials last refreshed its copy on 31 Oct 2026.