Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01044550

Enrollment

Registered

2010-01-08

Start date

2009-09-30

Completion date

2014-10-31

Last updated

2015-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Injury

Keywords

Diaphragm injury, Herniation

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.

Interventions

PROCEDURELaparoscopy

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

OTHERClinical follow up

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026