Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Not Applicable

Completed

• Conditions: Diaphragm Injury
• Interventions: Procedure: Laparoscopy; Other: Clinical follow up

• Registration Number: NCT01044550
• Lead Sponsor: University of Cape Town

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Hemodynamically stable patients
• 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

Exclusion Criteria

• Hemodynamically unstable patients
• Previous penetrating injury to the area mentioned under inclusion criteria
• Patients requiring early surgical exploration for injuries other than diaphragm injuries
• If a diaphragm injury is detected on imaging
• A positive pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Laparoscopy	Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Control	Clinical follow up	Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa