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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

This study is currently recruiting participants.
Verified September 2012 by University of Cape Town
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by (Responsible Party):
PH NAVSARIA, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01044550
First received: January 7, 2010
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  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 Blind (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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044550

Contacts
Contact: Pradeep Navsaria, FCS (SA) +2721404 4117 pradeep.navsaria@uct.ac.za

Locations
South Africa
University of Cape Town Recruiting
Cape Town, Western Cape, South Africa
Principal Investigator: Pradeep Navsaria, FCS(SA)            
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

No publications provided

Responsible Party: PH NAVSARIA, Assoc Professor, University of Cape Town
ClinicalTrials.gov Identifier: NCT01044550     History of Changes
Other Study ID Numbers: mlhgid004
Study First Received: January 7, 2010
Last Updated: September 17, 2012
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:
Diaphragm injury
Herniation

ClinicalTrials.gov processed this record on June 17, 2013