Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Diaphragm Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044550
• Other study ID #: mlhgid004
• Status: Completed
• Phase: N/A
• First received: January 7, 2010
• Last updated: January 21, 2015
• Start date: September 2009
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diaphragm Injury

Intervention

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.

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No