Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:26 AM
Study NCT ID:
NCT04412512
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2020-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VATS Versus Thoracotomy for Pulmonary Hydatid Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004445', 'term': 'Echinococcosis, Pulmonary'}], 'ancestors': [{'id': 'D004443', 'term': 'Echinococcosis'}, {'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008174', 'term': 'Lung Diseases, Parasitic'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study the effect of a treatment and evaluate outcome postoperative'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days', 'description': 'evaluate the complication at 30 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary hydatid cyst', 'video-assisted thoracic surgery', 'thoracotomy'], 'conditions': ['Pulmonary Hydatid Cyst']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy and safety of minimally invasive surgery and compare the outcomes with patients undergoing thoracotomy in treatment of Pulmonary Hydatid Cyst.\n\nDisease : pulmonary hydatid cyst.\n\nIntervention:\n\n* Group 1 : VATS approach.\n* Group 2 : thoracotomy approach.', 'detailedDescription': 'After being informed about the study and the approach, all patients giving written informed consent to determine eligibility for study entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- all patients underwent surgery for pulmonary hydatid cyst\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04412512', 'acronym': 'VATS', 'briefTitle': 'VATS Versus Thoracotomy for Pulmonary Hydatid Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hassan II University'}, 'officialTitle': 'VATS Versus Thoracotomy for Pulmonary Hydatid Disease', 'orgStudyIdInfo': {'id': 'VATS for pulmonary hydatid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VATS approach', 'description': 'patients treated by VATS technique.', 'interventionNames': ['Procedure: VATS approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracotomy approach', 'description': 'patients treated by Thoracotomy technique', 'interventionNames': ['Procedure: Thoracotomy approach']}], 'interventions': [{'name': 'VATS approach', 'type': 'PROCEDURE', 'description': 'video-assisted thoracic surgery approach', 'armGroupLabels': ['VATS approach']}, {'name': 'Thoracotomy approach', 'type': 'PROCEDURE', 'armGroupLabels': ['Thoracotomy approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Hassan II University', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}], 'overallOfficials': [{'name': 'sara WAGUAF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hassan II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hassan II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara WAGUAF', 'investigatorAffiliation': 'Hassan II University'}}}}