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Enhanced Recovery After Trauma Surgery (ERATS)

Primary Purpose

Penetrating Abdominal Trauma

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Enhanced Recovery Measures
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penetrating Abdominal Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years
  • Penetrating abdominal trauma
  • Require emergency laparotomy
  • Alert ( Glasgow Coma Scale - 15/15)
  • Able to consent
  • Hemodynamically stable

Exclusion Criteria:

  • Additional extra-abdominal injuries
  • Spinal cord injuries
  • Requiring damage control surgery from initial assessment (hemodynamically unstable )
  • Do not consent to the study
  • Need for ICU admission from initial surgery
  • Pregnant patients
  • All Duodenal injuries
  • All Bladder injuries
  • Previous laparotomies

Sites / Locations

  • Groote Schuur Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

ERATS

Arm Description

Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care

Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .

Outcomes

Primary Outcome Measures

Length of hospital stay
Duration of admission to the hospital

Secondary Outcome Measures

Early feeding post explorative laparotomy
Days to tolerating full ward diet
Early removal of Nasogastric tubes, urinary catheters ,drains
Days to complete ambulation
Comparative mortality between the control and ERATS group
30 day mortality
Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively
Comparative daily pain score evaluation with Visual Analogue Score between control and ERATS group
Benefit of early mobilization post exploratory laparotomy
Time taken to return to normal activities of daily living, complete ambulation
Cost comparative between the 2 groups
Average cost between the 2 groups based on days in hospital , medication and consumables used
Morbidity in control group compared to ERATS group
Post operative surgical complications will be graded according to the extended Clavien-Dindo scoring system

Full Information

First Posted
April 5, 2019
Last Updated
December 8, 2022
Sponsor
University of Cape Town
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1. Study Identification

Unique Protocol Identification Number
NCT03920163
Brief Title
Enhanced Recovery After Trauma Surgery
Acronym
ERATS
Official Title
Enhanced Recovery After Trauma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ERAS IN TRAUMA Enhanced recovery after surgery (ERAS) or enhanced recovery protocols (ERP) is a concept first described by Kehlet in the early 1990s .Since its introduction, ERAS protocols have been successfully used in elective gastrointestinal surgery (colorectal, hepatobiliary and gastric), and there has been widespread acceptance and implementation in other surgical disciplines including urology, vascular , thoracic surgery and orthopaedics. The approach employs a multimodal perioperative care pathway designed to attenuate the surgical stress response and accelerate postoperative recovery . These benefits should be easily transferrable to the trauma patient population, if not greater, since trauma patients are generally younger, fitter and metabolically stable. Trauma centres in developing countries constantly battle with reduced bed availability and restricted health care budgets. Optimization of health care practice is therefore urgent, particularly in trauma surgery. Penetrating abdominal trauma is a major cause of morbidity and mortality in large urban trauma centres. It accounts for a significant number of hospital admissions and consumes a large portion of the health care budget. In the trauma patient, the aim is to maintain the 'pre- injury' physiological status. Improving patient outcomes with reduced morbidity and early hospital discharge reduces the cost of treating these patients . The small pilot study by Moydien et al., showed that ERPS can be successfully implemented with significant shorter hospital stays without any increase in postoperative complications in a select group of trauma patients undergoing emergency laparotomy for isolated penetrating abdominal trauma. Furthermore, the study showed that ERPS can also be applied to patients undergoing emergency surgery. Given the fact that penetrating abdominal trauma remains a substantial burden of disease, especially in developing countries such as South Africa, this proven approach to patient care in elective surgery can now be safely employed in the trauma and emergency setting. Penetrating abdominal trauma remains a substantial burden of disease, especially in developing countries such as South Africa, and especially the Western Cape, where we have seen an increase in the number of trauma patients being treated for penetrating injuries at our level 1 centre. This has in turn led to severe constraints on the available resources, with the trauma ward often at maximum capacity with delayed discharges due to poor ambulation, post operative complications, and delay in return to enteral feeding. Currently there is no randomized controlled study in the trauma literature, evaluating enhanced recovery after trauma procedures .It is our hypothesis to that implementing an "ERATS" protocol , will lead to a reduction in morbidity, reduction in hospital stay , with a subsequent decrease in costs. This will allow us to implement this as a new standard protocol , and thus change the current practice in stable penetrating trauma patients undergoing explorative laparotomy in our unit, nationally and worldwide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penetrating Abdominal Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care
Arm Title
ERATS
Arm Type
Experimental
Arm Description
Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .
Intervention Type
Other
Intervention Name(s)
Enhanced Recovery Measures
Intervention Description
Perioperative measures
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Duration of admission to the hospital
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Early feeding post explorative laparotomy
Description
Days to tolerating full ward diet
Time Frame
7 days
Title
Early removal of Nasogastric tubes, urinary catheters ,drains
Description
Days to complete ambulation
Time Frame
7 days
Title
Comparative mortality between the control and ERATS group
Description
30 day mortality
Time Frame
30 days
Title
Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively
Description
Comparative daily pain score evaluation with Visual Analogue Score between control and ERATS group
Time Frame
7 days
Title
Benefit of early mobilization post exploratory laparotomy
Description
Time taken to return to normal activities of daily living, complete ambulation
Time Frame
7 days
Title
Cost comparative between the 2 groups
Description
Average cost between the 2 groups based on days in hospital , medication and consumables used
Time Frame
30 days
Title
Morbidity in control group compared to ERATS group
Description
Post operative surgical complications will be graded according to the extended Clavien-Dindo scoring system
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years Penetrating abdominal trauma Require emergency laparotomy Alert ( Glasgow Coma Scale - 15/15) Able to consent Hemodynamically stable Exclusion Criteria: Additional extra-abdominal injuries Spinal cord injuries Requiring damage control surgery from initial assessment (hemodynamically unstable ) Do not consent to the study Need for ICU admission from initial surgery Pregnant patients All Duodenal injuries All Bladder injuries Previous laparotomies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Nicol, FCS(SA)
Organizational Affiliation
University of Cape Town
Official's Role
Study Director
Facility Information:
Facility Name
Groote Schuur Hospital
City
Cape Town
State/Province
Western Vape
ZIP/Postal Code
7925
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhanced Recovery After Trauma Surgery

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