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| Name | Class |
|---|---|
| Medical Research Council, South Africa | OTHER |
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Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury |
|
| Control | Active Comparator | Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy | Procedure | Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pradeep Navsaria, FCS (SA) | University of Cape Town | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cape Town | Cape Town | Western Cape | South Africa |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Clinical follow up | Other | Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up. |
|
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |