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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Primary Purpose

Diaphragm Injury

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Laparoscopy
Clinical follow up
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diaphragm Injury focused on measuring Diaphragm injury, Herniation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Cape Town

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Treatment

Control

Arm Description

Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury

Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2010
Last Updated
January 21, 2015
Sponsor
University of Cape Town
Collaborators
Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT01044550
Brief Title
Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
Medical Research Council, South Africa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Injury
Keywords
Diaphragm injury, Herniation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy
Intervention Description
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
Intervention Type
Other
Intervention Name(s)
Clinical follow up
Intervention Description
Control group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Navsaria, FCS (SA)
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cape Town
City
Cape Town
State/Province
Western Cape
Country
South Africa

12. IPD Sharing Statement

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Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

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