Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-22 @ 3:42 AM
Study NCT ID:
NCT00841750
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D003074', 'term': 'Solitary Pulmonary Nodule'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pneumothorax >10% / Hemothorax', 'timeFrame': '1 hour and 1-5 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Pain (Visual analogue scale)', 'timeFrame': 'At days 1-5 of hospitalization and at 1 month'}, {'measure': 'Surgical procedure duration', 'timeFrame': 'At the end of surgery'}, {'measure': 'Hospital stay', 'timeFrame': 'At patient discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chest Tubes', 'Thoracic Surgery, Video-Assisted', 'Lung Diseases, Interstitial', 'Pulmonary Nodule, Solitary'], 'conditions': ['Lung Diseases, Interstitial', 'Pulmonary Nodule, Solitary']}, 'descriptionModule': {'briefSummary': 'After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax \\< 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.\n* No evidence of air leak at the end of the surgical procedure.\n* No active bleeding at the end of the surgical procedure.\n\nExclusion Criteria:\n\n* Pleural effusion previous to the procedure requiring drainage after it.\n* Bullous or emphysematous changes in lung parenchyma.\n* Patients going to positive pressure in the airways after the procedure.'}, 'identificationModule': {'nctId': 'NCT00841750', 'acronym': 'NOTUBE', 'briefTitle': 'Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle'}, 'officialTitle': 'The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.', 'orgStudyIdInfo': {'id': '9009001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No chest tube', 'description': 'No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.', 'interventionNames': ['Procedure: Do not leave a chest tube in the pleural cavity.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chest tube', 'description': 'Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.', 'interventionNames': ['Procedure: Do leave a chest tube in the pleural cavity.']}], 'interventions': [{'name': 'Do not leave a chest tube in the pleural cavity.', 'type': 'PROCEDURE', 'description': 'At the end of a VATS wedge resection, an air leak proof will take place and if no air leak is noted, the surgical incisions for thoracoscopy ports will be closed without leaving a chest tube inserted in the pleural cavity of the patient.', 'armGroupLabels': ['No chest tube']}, {'name': 'Do leave a chest tube in the pleural cavity.', 'type': 'PROCEDURE', 'description': 'At the end of a VATS wedge resection, a chest tube will be inserted in the pleural cavity of the patient through the inferior surgical incision for thoracoscopy port; the rest of the incisions will be closed.', 'armGroupLabels': ['Chest tube']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'state': 'Bogota D.C.', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Luis G Garcia-Herreros, MD', 'role': 'CONTACT', 'email': 'info@luisgarciaherrerosmd.com', 'phone': '(57)1 2152300', 'phoneExt': '1613'}, {'name': 'Luis G Garcia-Herreros, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundacion Santa Fe de Bogota', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Bucaramanga', 'state': 'Santander Department', 'status': 'NOT_YET_RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Carlos E Garavito, MD', 'role': 'CONTACT', 'email': 'cegaravito@hotmail.com'}, {'name': 'Luis F Tapias-Vargas', 'role': 'CONTACT', 'email': 'ftapias@gmail.com', 'phone': '76382822'}, {'name': 'Carlos E Garavito, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luis F Tapias-Vargas', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura I Valencia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Chicamocha', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'city': 'Floridablanca', 'state': 'Santander Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Leonidas Tapias, MD', 'role': 'CONTACT', 'email': 'ltapias@intercable.net.co', 'phone': '76384160', 'phoneExt': '1717'}, {'name': 'Leonidas Tapias-Vargas, MD', 'role': 'CONTACT', 'email': 'ltapias@msn.com', 'phone': '76382822'}, {'name': 'Leonidas Tapias, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leonidas Tapias-Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle', 'geoPoint': {'lat': 7.06222, 'lon': -73.08644}}], 'overallOfficials': [{'name': 'Leonidas Tapias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle'}, {'name': 'Luis C Orozco-Vargas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Industrial de Santander'}, {'name': 'Luis F Tapias-Vargas', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Industrial de Santander'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Industrial de Santander', 'class': 'OTHER'}, {'name': 'Clinica Chicamocha', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Leonidas Tapias Diaz', 'oldOrganization': 'Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle'}}}}