Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT06424457
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016724', 'term': 'Empyema, Pleural'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004653', 'term': 'Empyema'}, {'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': 'D020775', 'term': 'Thoracic Surgery, Video-Assisted'}], 'ancestors': [{'id': 'D013906', 'term': 'Thoracoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D020535', 'term': 'Video-Assisted Surgery'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound size', 'timeFrame': 'after 1week post operative', 'description': 'by centimeters'}, {'measure': 'wound infection', 'timeFrame': 'during 1week post operative', 'description': 'which degree of infection or if there is a burst wound'}, {'measure': 'hospital stay', 'timeFrame': '1week post operative', 'description': 'by days post operative'}, {'measure': 'air leak duration', 'timeFrame': 'during 1week post operative', 'description': 'by days and takes how many days to stop air leakage'}, {'measure': 'pain score', 'timeFrame': 'during 1week post operative.', 'description': 'through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)'}, {'measure': 'Early mobilization.', 'timeFrame': 'during 1week post operative', 'description': 'how many days'}], 'secondaryOutcomes': [{'measure': 'chronic pain', 'timeFrame': 'after 1month post operative', 'description': 'presented or not'}, {'measure': 'avoidance of scoliosis', 'timeFrame': 'after 1month post operative', 'description': 'which degree'}, {'measure': 'shoulder muscle girdle weakness and deformity.', 'timeFrame': 'after 1month post operative', 'description': 'yes or no'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric empyema', 'VATS decortication'], 'conditions': ['Thoracic Empyema']}, 'referencesModule': {'references': [{'pmid': '33334937', 'type': 'BACKGROUND', 'citation': 'Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.'}, {'pmid': '26919911', 'type': 'BACKGROUND', 'citation': 'Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.'}, {'pmid': '26807282', 'type': 'BACKGROUND', 'citation': 'Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.'}, {'pmid': '30707629', 'type': 'BACKGROUND', 'citation': 'Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.\n\nThe aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.', 'detailedDescription': 'comparison between VATS decortication and open thoracotomy in cases of pediatric empyema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients 1 yrs. : ≤ 18 yrs.\n* Patients with empyema due to pneumonia.\n* Patients with empyema had lasted for fewer than 3 weeks.\n\nExclusion Criteria:\n\n* Patients \\< 1 yrs. old.\n* Patients with whom pleural empyema had lasted for more than 3 weeks.\n* Patients with empyema had been caused by trauma.\n* Patients whose parents refuse to be included in the study.\n* Patients with empyema due to ruptured lung abscess.\n* Patients with empyema due to chest wall abscess.\n* Patients with empyema due to rib osteomyelitis.\n* Patients with bronchopleural fistula.\n* Patients with post-surgical empyema.'}, 'identificationModule': {'nctId': 'NCT06424457', 'acronym': 'VATS', 'briefTitle': 'Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients', 'orgStudyIdInfo': {'id': '04-2024-100227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A (VATS)', 'description': '(group A) will receive VATS decortication as their definite management', 'interventionNames': ['Procedure: video assisted thoracoscopy (VATS)']}, {'type': 'EXPERIMENTAL', 'label': 'group B (open thoracotomy)', 'description': '(group B) will be assigned to open thoracotomy', 'interventionNames': ['Procedure: open thoracotomy']}], 'interventions': [{'name': 'video assisted thoracoscopy (VATS)', 'type': 'PROCEDURE', 'description': 'the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy', 'armGroupLabels': ['group A (VATS)']}, {'name': 'open thoracotomy', 'type': 'PROCEDURE', 'description': 'the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy', 'armGroupLabels': ['group B (open thoracotomy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+2088', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ali zein elabdein, MD', 'role': 'CONTACT', 'email': 'ali_zein@aun.edu.eg', 'phone': '+201014566896'}, {'name': 'hussein Elkhayat, prof.', 'role': 'CONTACT', 'email': 'elkhayat@aun.edu.eg', 'phone': '+201005549653'}], 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'ali zein eladein, Ass.Lect.', 'role': 'CONTACT', 'email': 'ali_zein@aun.edu.eg', 'phone': '+201014566896'}, {'name': 'hussein Elkhayat, Assoc. Prof.', 'role': 'CONTACT', 'email': 'elkhayat@aun.edu.eg', 'phone': '+201005549653'}], 'overallOfficials': [{'name': 'Mohamed Ayyad, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}, {'name': 'Mahmoud sallam, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ali zein elabdein abd elaleim', 'investigatorAffiliation': 'Assiut University'}}}}