Outcomes After Laparotomy for Penetrating Abdominal Trauma

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT04536818
• Collaborator: University of Stellenbosch (Other)
• Enrollment: 196
• Location: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 32.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Penetrating Abdominal Trauma	Procedure: Laparotomy

Study Design

• Study Type: Observational
• Actual Enrollment: 196 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Outcomes After Laparotomy for Penetrating Abdominal Trauma: A Cohort Study From a Tertiary Trauma Hospital in South Africa
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Time to surgery ≤12 hours Waiting time to surgery ≤12 hours from hospital presentation.	Procedure: Laparotomy; Exploratory laparotomy.
Time to surgery >12 hours Waiting time to surgery >12 hours from hospital presentation.	Procedure: Laparotomy; Exploratory laparotomy.

Outcome Measures

Primary Outcome Measures

1. Death [Through study completion, an average of 2 weeks]

   In-hospital death.

Secondary Outcome Measures

1. Complications [Through study completion, an average of 2 weeks]

   Complications according to the Clavien-Dindo classification.

2. Length of stay [Through study completion, an average of 2 weeks]

   Length of hospital stay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tygerberg Academic Hospital	Cape Town	Western Cape Province	South Africa

Sponsors and Collaborators

• Karolinska Institutet
• University of Stellenbosch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andreas Älgå, Principal Investigator, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04536818
• Other Study ID Numbers: TraumaLapCohort
• First Posted: Sep 3, 2020
• Last Update Posted: Sep 3, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries; Abdominal Injuries

Study Results

No Results Posted as of Sep 3, 2020