- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536818
Outcomes After Laparotomy for Penetrating Abdominal Trauma
August 27, 2020 updated by: Andreas Älgå, Karolinska Institutet
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
196
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Western Cape Province
-
Cape Town, Western Cape Province, South Africa
- Tygerberg Academic Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Time to surgery ≤12 hours
Waiting time to surgery ≤12 hours from hospital presentation.
|
Exploratory laparotomy.
|
Time to surgery >12 hours
Waiting time to surgery >12 hours from hospital presentation.
|
Exploratory laparotomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: Through study completion, an average of 2 weeks
|
In-hospital death.
|
Through study completion, an average of 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: Through study completion, an average of 2 weeks
|
Complications according to the Clavien-Dindo classification.
|
Through study completion, an average of 2 weeks
|
Length of stay
Time Frame: Through study completion, an average of 2 weeks
|
Length of hospital stay.
|
Through study completion, an average of 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 27, 2020
First Posted (Actual)
September 3, 2020
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TraumaLapCohort
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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