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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

NCT01044550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-01-22

No results posted yet for this study

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.

Conditions

  • Diaphragm Injury

Interventions

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.

Sponsors & Collaborators

  • Medical Research Council, South Africa

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Pradeep Navsaria, FCS (SA) · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01044550 on ClinicalTrials.gov