Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
NCT ID: NCT01044550
Last Updated: 2015-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2009-09-30
2014-10-31
Brief Summary
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Aim 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.
Objects of the Study: To obtain the above mentioned aim the study will undertake;
* to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury.
* to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Treatment
Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Laparoscopy
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
Control
Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
Clinical follow up
Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.
Interventions
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Laparoscopy
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
Clinical follow up
Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.
Eligibility Criteria
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Inclusion Criteria
* Patients with penetrating stab wounds bounded by
* Superiorly the 4th intercostal space
* Lateral the tip of the left scapula
* Inferior by the left costal margin
* Medially by the sternum
* Signed informed consent
* Patients requiring early surgical exploration for injuries other than diaphragm injuries
* If a diaphragm injury is detected on imaging
* A positive pregnancy test
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Medical Research Council, South Africa
OTHER
University of Cape Town
OTHER
Responsible Party
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PH NAVSARIA
Assoc Professor
Principal Investigators
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Pradeep Navsaria, FCS (SA)
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Locations
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University of Cape Town
Cape Town, Western Cape, South Africa
Countries
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Other Identifiers
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mlhgid004
Identifier Type: -
Identifier Source: org_study_id
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