Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT04566094
Status:
WITHDRAWN
Last Update Posted:
2025-03-30
First Post:
2020-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Herniation After Uniportal VATS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PIs moved to other department', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung herniation', 'timeFrame': 'Postoperative follow-up up to 6 months', 'description': 'Presence of intercostal lung herniation after uniportal VATS'}], 'secondaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': 'Postoperative follow-up to 5 years', 'description': 'Symptoms described by patients presenting an intercostal lung hernia'}, {'measure': 'Risk factors', 'timeFrame': 'At the time of operation', 'description': 'Presence of Risk factors associated with the development of intercostal lung hernia after uniportal VATS surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Hernia', 'Thoracoscopy', 'Postoperative']}, 'descriptionModule': {'briefSummary': "During patient follow up the investigators noticed the occasional occurence of a lung herniation after uniportal Video assisted thoracoscopic surgery (VATS). Most of These patients were asymptomatic and didn't require any kind of treatment. To analyse the incidence of postoperative lung herniation after uniportal and the presence of symptoms the investigators decided to review every postoperative CT scan from January 2016 until March 2019 to radiologically identify postoperative lung herniations. Afterwards the investigators will contact the respective patient to ask for a follow-up physical examination and symptom evaluation (after consent was signed)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Every patient submitted to uniportal VATS anatomic lung resection from January 2016 until March 2019 who has had a postoperative radiological follow up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anatomical lung resection using uniportal VATS\n\nExclusion Criteria:\n\n* Non anatomical lung resection\n* Open surgery\n* Pneumonectomy\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT04566094', 'briefTitle': 'Lung Herniation After Uniportal VATS', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Lung Herniation After Uniportal VATS. Rarity or Common Finding?', 'orgStudyIdInfo': {'id': '17092020'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jon Lutz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of General Thoracic Surgery Bern University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}