Enhanced Recovery After Trauma Surgery (ERATS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Penetrating Abdominal Trauma
• Intervention / Treatment: Other: Enhanced Recovery Measures

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Vape
    • Cape Town, Western Vape, South Africa, 7925
      • Groote Schuur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care	Other: Enhanced Recovery Measures; Perioperative measures
Experimental: ERATS; Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .	Other: Enhanced Recovery Measures; Perioperative measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Duration of admission to the hospital	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early feeding post explorative laparotomy	Days to tolerating full ward diet	7 days
Early removal of Nasogastric tubes, urinary catheters ,drains	Days to complete ambulation	7 days
Comparative mortality between the control and ERATS group	30 day mortality	30 days
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	7 days
Benefit of early mobilization post exploratory laparotomy	Time taken to return to normal activities of daily living, complete ambulation	7 days
Cost comparative between the 2 groups	Average cost between the 2 groups based on days in hospital , medication and consumables used	30 days
Morbidity in control group compared to ERATS group	Post operative surgical complications will be graded according to the extended Clavien-Dindo scoring system	30 days

Collaborators and Investigators

• Sponsor: University of Cape Town
• Investigators: Study Director: Andrew Nicol, FCS(SA), University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: ERATS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No