Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Study Overview
=================
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.

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

Conditions
-----------------
Diaphragm Injury

Intervention / Treatment
-----------------
* Procedure: Laparoscopy
* Other: Clinical follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury | Procedure: Laparoscopy<br>* Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found<br>|
| Active Comparator: Control<br>Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group. | Other: Clinical follow up<br>* Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diaphragm injury, Herniation