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Enhanced Recovery After Trauma Surgery (ERATS)

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ClinicalTrials.gov Identifier: NCT03920163
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Dr DEK McPherson, University of Cape Town

Study Description
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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.


Condition or disease Intervention/treatment Phase
Penetrating Abdominal Trauma Other: Enhanced Recovery Measures Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Recovery After Trauma Surgery
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 7 days ]
    Duration of admission to the hospital


Secondary Outcome Measures :
  1. Early feeding post explorative laparotomy [ Time Frame: 7 days ]
    Days to tolerating full ward diet

  2. Early removal of Nasogastric tubes, urinary catheters ,drains [ Time Frame: 7 days ]
    Days to complete ambulation

  3. Comparative mortality between the control and ERATS group [ Time Frame: 30 days ]
    30 day mortality

  4. Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively [ Time Frame: 7 days ]
    Comparative daily pain score evaluation with Visual Analogue Score between control and ERATS group

  5. Benefit of early mobilization post exploratory laparotomy [ Time Frame: 7 days ]
    Time taken to return to normal activities of daily living, complete ambulation

  6. Cost comparative between the 2 groups [ Time Frame: 30 days ]
    Average cost between the 2 groups based on days in hospital , medication and consumables used

  7. Morbidity in control group compared to ERATS group [ Time Frame: 30 days ]
    Post operative surgical complications will be graded according to the extended Clavien-Dindo scoring system


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920163


Contacts
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Contact: Deidré E McPherson, FCS(SA) +27720620196 drdeidremcpherson@gmail.com
Contact: Sorin Edu, FCS(SA) +274044490 sorinedu@yahoo.com

Locations
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South Africa
Groote Schuur Hospital Recruiting
Cape Town, Western Vape, South Africa, 7925
Contact: Deidré E McPherson, FCS(SA)    0720620196    drdeidremcpherson@gmail.com   
Contact: Andrew Nicol, FCS(SA)    +274044114    andrew.nicol@uct.ac.za   
Sponsors and Collaborators
University of Cape Town
Investigators
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Study Director: Andrew Nicol, FCS(SA) University of Cape Town
More Information
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Responsible Party: Dr DEK McPherson, Principal Investigator, University of Cape Town
ClinicalTrials.gov Identifier: NCT03920163    
Other Study ID Numbers: ERATS
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Abdominal Injuries