Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-28 @ 1:31 AM
Study NCT ID:
NCT07035366
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Procedures for Uniportal Video Assisted Thoracoscopic Surgery to Treat Severe Cases of Diaphragmatic Eventration in Adult
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003965', 'term': 'Diaphragmatic Eventration'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic & Recovery Time (days)', 'timeFrame': '1 week after surgery'}, {'measure': 'operative time (min)', 'timeFrame': 'from the start of skin incision till the extubation of the patient'}, {'measure': 'postoperative pain(pain score)', 'timeFrame': 'postoperative pain recieved by operated patient'}, {'measure': 'lung function recovery (lung function test)', 'timeFrame': 'lung function test done one and three months postoperative', 'description': 'forced expiratory volume in 1st second,'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stabled resection', 'running sutures', 'diaphragmatic eventration'], 'conditions': ['Diaphragmatic Eventration']}, 'descriptionModule': {'briefSummary': 'highly elevated abnormal diaphragm is lowered to normal position by runuing suture accordion shaped or cut part of diphragm by stabler', 'detailedDescription': 'high degree of eventration is corrected either stabled resection or running sutures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who presented with dyspnea or orthopnea with sever eventration\n\nExclusion Criteria:\n\n* other causes of dyspnea or elevated hemidiaphragm'}, 'identificationModule': {'nctId': 'NCT07035366', 'briefTitle': 'Two Procedures for Uniportal Video Assisted Thoracoscopic Surgery to Treat Severe Cases of Diaphragmatic Eventration in Adult', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Two Procedures for Uniportal Video Assisted Thoracoscopic Surgery to Treat Severe Cases of Diaphragmatic Eventration in Adult', 'orgStudyIdInfo': {'id': 'ZU-IRB # 738/15-oct-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'running sutures', 'description': 'diaphragmatic plication by running sutures', 'interventionNames': ['Procedure: running sutures']}, {'type': 'EXPERIMENTAL', 'label': 'stabled resection', 'description': 'diaphragmatic plication by stabled resection', 'interventionNames': ['Procedure: stabled resection']}], 'interventions': [{'name': 'stabled resection', 'type': 'PROCEDURE', 'description': 'diaphragmatic plication of sever eventration by stabled resection', 'armGroupLabels': ['stabled resection']}, {'name': 'running sutures', 'type': 'PROCEDURE', 'description': 'plication of diaphragmatic eventration by running sutures', 'armGroupLabels': ['running sutures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Cardiothoracic Surgery Department-Faculty of Mdecine-Zagazig Univeristy', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Dina Mohamed Osman', 'investigatorAffiliation': 'Zagazig University'}}}}