NCT04536818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 21, 2020

Last Update Submit

August 27, 2020

Conditions

Penetrating Abdominal Trauma

Outcome Measures

Primary Outcomes (1)

  • Death

    In-hospital death.

    Through study completion, an average of 2 weeks

Secondary Outcomes (2)

  • Complications

    Through study completion, an average of 2 weeks

  • Length of stay

    Through study completion, an average of 2 weeks

Study Arms (2)

Time to surgery ≤12 hours

Waiting time to surgery ≤12 hours from hospital presentation.

Procedure: Laparotomy

Time to surgery >12 hours

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

Procedure: Laparotomy

Interventions

LaparotomyPROCEDURE

Exploratory laparotomy.

Time to surgery >12 hoursTime to surgery ≤12 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Tygerberg Academic Hospital, Cape Town, South Africa.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tygerberg Academic Hospital

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Interventions

Laparotomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2020

First Posted

September 3, 2020

Study Start

April 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

September 3, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)