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Diaphragm Injury | Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Diaphragm Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diaphragm Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:LaparoscopyTreatment group will undergo a laparoscopy, with repair of the diaphragm if injury found

Other:Clinical follow upControl group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TreatmentLaparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury

ControlAssess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.

Study Status

Completed

Start Date: September 2009

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Pradeep Navsaria, FCS (SA)

Lead Sponsor: University of Cape Town

Collaborator: Medical Research Council, South Africa

More information:https://clinicaltrials.gov/show/NCT01044550

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