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Completed

NCT Number: NCT01044550

Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

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.

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Key information

Conditions

Diaphragm Injury Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cape Town

Cape Town, Western Cape, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopy

Procedure

Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found

Clinical follow up

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • Medical Research Council, South Africa

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2010
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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