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

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.

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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