Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 5:06 AM
Study NCT ID:
NCT06325904
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uniportal VATS Versus Chest Tube for Early Empyema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016724', 'term': 'Empyema, Pleural'}, {'id': 'D004653', 'term': 'Empyema'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015505', 'term': 'Chest Tubes'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-16', 'studyFirstSubmitQcDate': '2024-03-16', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for further management', 'timeFrame': '6 months after inital treatment', 'description': 'Need for further method for pleural fluid drainage or decortication.'}, {'measure': 'Mortality', 'timeFrame': '6 months after inital treatment', 'description': 'Postoperative in-hospital or follow-up death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Video-assisted thoracoscopic surgery', 'Pleura', 'Empyema'], 'conditions': ['Empyema, Pleural']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study compared uniportal video-assisted thoracoscopic surgery (U-VATS) versus chest tube drainage for initial (first-line) treatment of stage I (exudative) and stage II (fibrinopurulent) empyema in adult patients (\\>18 years old). The primary end-point of outcome was the overall success of treatment (no need for re-intervention or death). The main results demonstrated the safety of minimally invasive U-VATS procedure in the initial treatment of early stages of pleural empyema in comparison to traditional chest tube drainage. Initial use of U-VATS was safe and feasible due to postoperative freedom from complex or marked effusion, in addition to significant reduction in the need for additional intervention, postoperative complications, length of hospital stay, and total cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed to have empyema and indicated for surgery.\n* Age above 18 years old\n\nExclusion Criteria:\n\n* Inability to tolerate single lung ventilation.\n* Contraindication for general anesthesia/ medically unfit'}, 'identificationModule': {'nctId': 'NCT06325904', 'briefTitle': 'Uniportal VATS Versus Chest Tube for Early Empyema', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Uniportal Video Assisted Thoracoscopic Surgery (VATS) Debridement Versus Chest Tube Drainage in Early Stage Empyema', 'orgStudyIdInfo': {'id': '9138930'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '* This group included 30 adult patients with stage I/II pleural empyema who operated initially by VATS.\n* All patients were subjected to the following:\n\n 1\\. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest.\n* All patients will be managed by general anesthesia using double lumen endoteracheal tube to achieve single lung ventilation.\n* All patients were positioned in lateral decubitus position.\n* Single port skin incisions was made to pass the port through which the camera head and instruments were introduced into the chest .\n* One chest tubes ws inserted as drains.', 'interventionNames': ['Procedure: Uniportal VATS']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': '* This group included 30 adult patients with stage I/II pleural empyema who underwent conventional tube thoracotomy.\n* All patients were subjected to the following:\n\n 1\\. Full history taking. 2.Full clinical examination. 3-Routine Laboratory investigations and Pleural fluid sample analysis. 4- Radiological investigations: Chest X-ray , CT chest.\n* The patient is placed in a supine position.\n* The intercostals pace is opened .\n* Chest tube is inserted in proper position regarding the site of fluid collection.', 'interventionNames': ['Procedure: Tube thoracostomy']}], 'interventions': [{'name': 'Uniportal VATS', 'type': 'PROCEDURE', 'description': '* single port video-assisted thoracoscopic surgery in the 5th intercostal space\n* performed under general anesthesia.\n* pleural fluid/pus was drained\n* pleural adhesions was removed', 'armGroupLabels': ['1']}, {'name': 'Tube thoracostomy', 'type': 'PROCEDURE', 'otherNames': ['Chest tube'], 'description': '* Chest tube is inserted in 5th mid-axillary line\n* performed under local anaesthesia', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Mostafa M Elsayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Yasser Ali Kamal', 'investigatorAffiliation': 'Minia University'}}}}