NCT01044550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

5.1 years

First QC Date

January 7, 2010

Last Update Submit

January 21, 2015

Conditions

Diaphragm Injury

Keywords

Diaphragm injuryHerniation

Outcome Measures

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.

    2 years

Study Arms (2)

Treatment

OTHER

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

Procedure: Laparoscopy

Control

ACTIVE COMPARATOR

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

Other: Clinical follow up

Interventions

LaparoscopyPROCEDURE

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

Treatment
Clinical follow upOTHER

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

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Hemodynamically unstable patients
  • Patients requiring early surgical exploration for injuries other than diaphragm injuries
  • If a diaphragm injury is detected on imaging
  • A positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

Hernia

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Pradeep Navsaria, FCS (SA)

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Professor

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

September 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

ZA(1)