NCT01044550

Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Cape Town · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diaphragm Injury

Interventions

Type	Name	Description
PROCEDURE	Laparoscopy	Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-01-08
• Last updated: 2015-01-22

Locations

1 site across 1 country: South Africa