Outcomes After Laparotomy for Penetrating Abdominal Trauma

Penetrating Abdominal Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536818
• Other study ID #: TraumaLapCohort
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 normotensive patients treated with laparotomy for penetrating abdominal trauma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Injuries
• Penetrating Abdominal Trauma
• Wounds and Injuries

Intervention

Procedure:
• Laparotomy
Exploratory laparotomy.

Locations

Country	Name	City	State
South Africa	Tygerberg Academic Hospital	Cape Town	Western Cape Province

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	In-hospital death.	Through study completion, an average of 2 weeks
Secondary	Complications	Complications according to the Clavien-Dindo classification.	Through study completion, an average of 2 weeks
Secondary	Length of stay	Length of hospital stay.	Through study completion, an average of 2 weeks