Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT02813733
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determinants of Thyroid Surgery Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-24', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent laryngeal nerve palsy', 'timeFrame': 'During inpatient stay and at 6 months following surgery', 'description': 'Systematic postoperative screening by laryngoscopy'}], 'secondaryOutcomes': [{'measure': 'Secondary hypoparathyroidism', 'timeFrame': 'During inpatient stay and at 6 months following surgery', 'description': 'Systematic postoperative screening based on hypocalcaemia \\< 2 mmoL/l or vitaminocalcic substitution'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thyroid surgery', 'surgical outcomes', 'patient safety', 'healthcare quality', 'surgeons performance'], 'conditions': ['Thyroid Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent a thyroid procedure during study period in 5 high volume referral centers in France were eligible for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All patients who underwent a thyroid procedure between April 2008 and July 2008.\n\nExclusion Criteria:\n\n\\- Participation refusal'}, 'identificationModule': {'nctId': 'NCT02813733', 'acronym': 'CATHY', 'briefTitle': 'Determinants of Thyroid Surgery Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes', 'orgStudyIdInfo': {'id': 'D50528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thyroid surgery', 'description': 'All patients who underwent a thyroid procedure in 5 high volume referral centers in France were eligible for inclusion.', 'interventionNames': ['Procedure: Thyroid surgery']}], 'interventions': [{'name': 'Thyroid surgery', 'type': 'PROCEDURE', 'description': 'Thyroidectomies performed by all surgeons in 5 academic hospitals in France.', 'armGroupLabels': ['Thyroid surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Jean-Christophe Lifante', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}