Outcomes After Laparotomy for Penetrating Abdominal Trauma

NCT ID: NCT04536818

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Penetrating Abdominal Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Time to surgery ≤12 hours

Waiting time to surgery ≤12 hours from hospital presentation.

Laparotomy

Intervention Type PROCEDURE

Exploratory laparotomy.

Time to surgery >12 hours

Waiting time to surgery \>12 hours from hospital presentation.

Laparotomy

Intervention Type PROCEDURE

Exploratory laparotomy.

Interventions

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Laparotomy

Exploratory laparotomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Stellenbosch

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Andreas Älgå

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tygerberg Academic Hospital

Cape Town, Western Cape, South Africa

Site Status

Countries

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South Africa

Other Identifiers

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TraumaLapCohort

Identifier Type: -

Identifier Source: org_study_id

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