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OpenTrials
Completed

NCT Number: NCT04536818

Outcomes After Laparotomy for Penetrating Abdominal Trauma

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.

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Key information

Conditions

Penetrating Abdominal Trauma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tygerberg Academic Hospital

Cape Town, Western Cape, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparotomy

Procedure

Exploratory laparotomy.

Primary outcomes

  1. Death

    Time frame: Through study completion, an average of 2 weeks

    In-hospital death.

Secondary outcomes

  1. Complications

    Time frame: Through study completion, an average of 2 weeks

    Complications according to the Clavien-Dindo classification.

  2. Length of stay

    Time frame: Through study completion, an average of 2 weeks

    Length of hospital stay.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • University of Stellenbosch

Registry information

Official study title

Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2020
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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