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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044550
First Posted: January 8, 2010
Last Update Posted: January 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Council, South Africa
Information provided by (Responsible Party):
PH NAVSARIA, University of Cape Town
  Purpose

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.

Condition Intervention
Diaphragm Injury Procedure: Laparoscopy Other: Clinical follow up

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by PH NAVSARIA, University of Cape Town:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ]

Enrollment: 66
Study Start Date: September 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Procedure: Laparoscopy
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
Active Comparator: Control
Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044550


Locations
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
University of Cape Town
Medical Research Council, South Africa
Investigators
Principal Investigator: Pradeep Navsaria, FCS (SA) University of Cape Town
  More Information

Responsible Party: PH NAVSARIA, Assoc Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT01044550     History of Changes
Other Study ID Numbers: mlhgid004
First Submitted: January 7, 2010
First Posted: January 8, 2010
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by PH NAVSARIA, University of Cape Town:
Diaphragm injury
Herniation

Additional relevant MeSH terms:
Wounds and Injuries