Outcomes After Laparotomy for Penetrating Abdominal Trauma | NCT04536818

Studies
Outcomes After Laparotomy for Penetrating Abdominal Trauma

NCT04536818

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Sep 3, 2020Actual

Enrollment

196Actual

Phase

Not provided

Conditions

Penetrating Abdominal Trauma

Interventions

Laparotomy

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Sep 30, 2019Actual

Completion Date

Sep 30, 2019Actual

First Submitted Date

Aug 21, 2020

First Submission Date that Met QC Criteria

Aug 27, 2020

First Posted Date

Sep 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2020

Last Update Posted Date

Sep 3, 2020Actual

Name	Class
University of Stellenbosch	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

196Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laparotomy	Procedure	Exploratory laparotomy.	Time to surgery >12 hours Time to surgery ≤12 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Death	In-hospital death.	Through study completion, an average of 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Complications	Complications according to the Clavien-Dindo classification.	Through study completion, an average of 2 weeks
Length of stay	Length of hospital stay.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tygerberg Academic Hospital		Cape Town	Western Cape		South Africa

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007813	Laparotomy

Ancestor Terms

ID	Term
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided