Diaphragm InjuryNCT01044550
Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury
A study testing Laparoscopy and Clinical follow up in people with Diaphragm Injury, run by University of Cape Town at 1 site in South Africa.
Trial summary
Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diaphragm Injury
- What is being tested?
- Laparoscopy and Clinical follow up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2009to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Laparoscopy, Clinical follow up
- Keywords
- Diaphragm injury, Herniation
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Treatment group will undergo a laparoscopy, with repair of the diaphragm if injury found
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury Receives: Procedure: Laparoscopy |
| Control | Active comparator | Assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group. Receives: Other: Clinical follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Principal investigator, PH NAVSARIA, University of Cape Town
- Investigators
- Pradeep Navsaria, FCS (SA), Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044550
- Sponsor's protocol ID
- mlhgid004
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2010
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01044550
- Acronym / sponsor ID
- mlhgid004
- Conditions
- Diaphragm Injury
- Keywords
- Diaphragm injury, Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- Sep 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Procedure: LaparoscopyLaparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury |
| Control | Active comparator | Other: Clinical follow upAssess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyTreatment group will undergo a laparoscopy, with repair of the diaphragm if injury found | Procedure or surgery | Treatment |
| Clinical follow upControl group will undergo no treatment except suturing of wounds and drainage of the hemo-pneumothorax, if present. Then clinical follow up. | Other | Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Navsaria, FCS (SA) principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy and Clinical follow up in people with Diaphragm Injury, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.