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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

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE March 29, 2019
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
Length of hospital stay [ Time Frame: 7 days ]
Duration of admission to the hospital
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Early feeding post explorative laparotomy [ Time Frame: 7 days ]
    Days to tolerating full ward diet
  • Early removal of Nasogastric tubes, urinary catheters ,drains [ Time Frame: 7 days ]
    Days to complete ambulation
  • Comparative mortality between the control and ERATS group [ Time Frame: 30 days ]
    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 [ Time Frame: 7 days ]
    Comparative daily pain score evaluation with Visual Analogue Score between control and ERATS group
  • Benefit of early mobilization post exploratory laparotomy [ Time Frame: 7 days ]
    Time taken to return to normal activities of daily living, complete ambulation
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Recovery After Trauma Surgery
Official Title  ICMJE Enhanced Recovery After Trauma Surgery
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Penetrating Abdominal Trauma
Intervention  ICMJE Other: Enhanced Recovery Measures
Perioperative measures
Study Arms  ICMJE
  • Active Comparator: Control
    Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care
    Intervention: Other: Enhanced Recovery Measures
  • Experimental: ERATS
    Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .
    Intervention: Other: Enhanced Recovery Measures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Deidré E McPherson, FCS(SA) +27720620196 drdeidremcpherson@gmail.com
Contact: Sorin Edu, FCS(SA) +274044490 sorinedu@yahoo.com
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920163
Other Study ID Numbers  ICMJE ERATS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr DEK McPherson, University of Cape Town
Study Sponsor  ICMJE University of Cape Town
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Nicol, FCS(SA) University of Cape Town
PRS Account University of Cape Town
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP