Penetrating Abdominal TraumaNCT04536818
Outcomes After Laparotomy for Penetrating Abdominal Trauma
An observational study of Penetrating Abdominal Trauma, run by Karolinska Institutet at 1 site in South Africa.
Trial summary
The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penetrating Abdominal Trauma
- What is being tested?
- Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 196 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Apr 2019to 30 Sep 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.
Who may be able to join
- Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment.
- Patients that are treated with laparotomy.
Who cannot join
- Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma.
- Patients who are dead on arrival.
- Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa
The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.
- Conditions
- Penetrating Abdominal Trauma
- Being tested
- Laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
Exploratory laparotomy.
| Study group | Role | What they receive |
|---|---|---|
| Time to surgery ≤12 hours | Waiting time to surgery ≤12 hours from hospital presentation. Receives: Procedure: Laparotomy | |
| Time to surgery >12 hours | Waiting time to surgery >12 hours from hospital presentation. Receives: Procedure: Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
In-hospital death.
Measured: Through study completion, an average of 2 weeks
Secondary outcomes (2)
Complications
Complications according to the Clavien-Dindo classification.
Measured: Through study completion, an average of 2 weeks
Length of stay
Length of hospital stay.
Measured: Through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Apr 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Abdominal TraumaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch
- Responsible party
- Principal investigator, Andreas Älgå, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536818
- Sponsor's protocol ID
- TraumaLapCohort
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa
- ClinicalTrials.gov ID
- NCT04536818
- Acronym / sponsor ID
- TraumaLapCohort
- Conditions
- Penetrating Abdominal Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- University of Stellenbosch
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 3 Sep 2020 (actual)
- 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.
The purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in South Africa. Our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time to surgery ≤12 hours | – | Procedure: LaparotomyWaiting time to surgery ≤12 hours from hospital presentation. |
| Time to surgery >12 hours | – | Procedure: LaparotomyWaiting time to surgery >12 hours from hospital presentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.
Key inclusion criteria (2 listed)
- Patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment.
- Patients that are treated with laparotomy.
Key exclusion criteria (3 listed)
- Patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma.
- Patients who are dead on arrival.
- Patients that are only re-admitted during the study period, i.e. patients that received primary treatment by TBH before study initiation.
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 |
|---|---|---|
| LaparotomyExploratory laparotomy. | Procedure or surgery | Time to surgery >12 hours, Time to surgery ≤12 hours |
Primary outcome
Death
Time frame: Through study completion, an average of 2 weeks
In-hospital death.
2 secondary outcomes
Complications
Time frame: Through study completion, an average of 2 weeks
Length of stay
Time frame: Through study completion, an average of 2 weeks
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 3 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penetrating Abdominal Trauma, run by Karolinska Institutet 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 2 inclusion and 3 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 3 Sep 2020. 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?
Death (time frame: Through study completion, an average of 2 weeks). 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 3 Sep 2020.