Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT01044550
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2010-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-21', 'studyFirstSubmitDate': '2010-01-07', 'studyFirstSubmitQcDate': '2010-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the clinical outcome of potential occult diaphragm injuries in patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diaphragm injury', 'Herniation'], 'conditions': ['Diaphragm Injury']}, 'descriptionModule': {'briefSummary': 'Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.\n\nAim of the Study: The aim of this study is to access the clinical outcome of potential occult diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.\n\nObjects of the Study: To obtain the above mentioned aim the study will undertake;\n\n* to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury.\n* to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodynamically stable patients\n* Patients with penetrating stab wounds bounded by\n* Superiorly the 4th intercostal space\n* Lateral the tip of the left scapula\n* Inferior by the left costal margin\n* Medially by the sternum\n* Signed informed consent\n\nExclusion Criteria:\n\n* Hemodynamically unstable patients\n* Previous penetrating injury to the area mentioned under inclusion criteria\n* Patients requiring early surgical exploration for injuries other than diaphragm injuries\n* If a diaphragm injury is detected on imaging\n* A positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT01044550', 'briefTitle': 'Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Laparoscopy (to Detect Occult Diaphragm Injury) Versus Clinical and Radiological Follow up to Detect Diaphragm Injury and Herniation, in Patients With Asymptomatic Left Thoracoabdominal Stab Wounds: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'mlhgid004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury', 'interventionNames': ['Procedure: Laparoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.', 'interventionNames': ['Other: Clinical follow up']}], 'interventions': [{'name': 'Laparoscopy', 'type': 'PROCEDURE', 'description': 'Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found', 'armGroupLabels': ['Treatment']}, {'name': 'Clinical follow up', 'type': 'OTHER', 'description': 'Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Pradeep Navsaria, FCS (SA)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council, South Africa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Professor', 'investigatorFullName': 'PH NAVSARIA', 'investigatorAffiliation': 'University of Cape Town'}}}}