Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05230420
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}, {'id': 'D010996', 'term': 'Pleural Effusion'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003250', 'term': 'Constriction'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall cost', 'timeFrame': '5 to 6 days', 'description': "The overall cost of the patient's hospital stay"}], 'secondaryOutcomes': [{'measure': 'Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag', 'timeFrame': 'up to 5 days', 'description': 'An important side effect to be studied'}, {'measure': 'total number of days with chest drain inserted', 'timeFrame': 'up to 5 days', 'description': 'Number of days chest drain remained inserted'}, {'measure': 'Number of chest x-rays', 'timeFrame': 'up to 5 days', 'description': 'Total number of chest x-rays'}, {'measure': 'Number of participants that faced other intervention associated side effects', 'timeFrame': 'up to 5 days', 'description': 'Subcutaneous emphysema, tension pneumothorax and others'}, {'measure': 'Number of participants with chest tube re-insertion', 'timeFrame': 'up to 5 days', 'description': 'An important side effect'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumothorax and Air Leak', 'Pneumothorax', 'Pleura Injury', 'Pleural Effusion']}, 'descriptionModule': {'briefSummary': 'Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post lung resection patients (via Uniportal VATS only)\n* Over the age of 18\n* indicated chest tube\n\nExclusion Criteria:\n\n* Under the age of 18'}, 'identificationModule': {'nctId': 'NCT05230420', 'briefTitle': 'Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Al-Quds University'}, 'officialTitle': 'Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries', 'orgStudyIdInfo': {'id': '02/REC-CT/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clamping', 'description': 'This arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal', 'interventionNames': ['Other: Clamping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Urine bag', 'description': 'The second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain', 'interventionNames': ['Other: Urine bag']}], 'interventions': [{'name': 'Clamping', 'type': 'OTHER', 'description': 'Clamping of chest tube', 'armGroupLabels': ['Clamping']}, {'name': 'Urine bag', 'type': 'OTHER', 'description': 'Attachment of a urine bag to chest tube', 'armGroupLabels': ['Urine bag']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hussein Elkhayat, MD', 'role': 'CONTACT', 'email': 'dr_khayat@hotmail.com'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Tanta', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Elkholy, MD', 'role': 'CONTACT', 'email': 'ahmed.elkholy@med.tanta.edu.eg'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Bertolaccini, MD', 'role': 'CONTACT', 'email': 'luca.bertolaccini@gmail.com'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'East Jerusalem', 'status': 'RECRUITING', 'country': 'Palestinian Territories', 'contacts': [{'name': 'Rami Alaraj, MD Candidate', 'role': 'CONTACT', 'email': 'ra.alaraj@gmail.com', 'phone': '0598488897', 'phoneExt': '970'}], 'facility': 'Makassed Hospital', 'geoPoint': {'lat': 31.78336, 'lon': 35.23388}}], 'centralContacts': [{'name': 'Firas Abuakar, MD', 'role': 'CONTACT', 'email': 'firasabuakar@gmail.com', 'phone': '052220068', 'phoneExt': '+972'}, {'name': 'Rami Alaraj, MD candidate', 'role': 'CONTACT', 'email': 'ra.alaraj@gmail.com', 'phone': '0598488897', 'phoneExt': '+970'}], 'overallOfficials': [{'name': 'Firas Abuakar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine'}, {'name': 'Osama Darras, MD candidate', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine'}, {'name': 'Hadeel Abedalhameed, MD candidate', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine'}, {'name': 'Rami Alaraj, MD candidate', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine'}, {'name': 'Rania Attiyeh, MD candidate', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Quds University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}, {'name': 'Tanta University', 'class': 'OTHER'}, {'name': 'European Institute of Oncology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}