Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
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|ClinicalTrials.gov Identifier: NCT01044550|
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : January 22, 2015
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;
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diaphragm Injury||Procedure: Laparoscopy Other: Clinical follow up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
Active Comparator: Control
Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
Other: 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.
- 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. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044550
|University of Cape Town|
|Cape Town, Western Cape, South Africa|
|Principal Investigator:||Pradeep Navsaria, FCS (SA)||University of Cape Town|