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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

U

University of Cape Town (UCT)

Status

Completed

Conditions

Diaphragm Injury

Treatments

Other: Clinical follow up
Procedure: Laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01044550
mlhgid004

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

Treatment
Other group
Description:
Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Treatment:
Procedure: Laparoscopy
Control
Active Comparator group
Description:
Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
Treatment:
Other: Clinical follow up

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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