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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Enhanced Recovery After Trauma Surgery

Clinicaltrials.gov identifier NCT03920163

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted May 29, 2020

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.

  • Condition or Disease:Penetrating Abdominal Trauma
  • Intervention/Treatment: Other: Enhanced Recovery Measures
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
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
  • 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
  • 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
Contacts

Contact: Deidré E McPherson, FCS(SA) +27720620196 drdeidremcpherson@gmail.com

Contact: Sorin Edu, FCS(SA) +274044490 sorinedu@yahoo.com

Locations

South Africa, Western Vape
Groote Schuur Hospital
Cape Town

Sponsors and Collaborators

University of Cape Town

Investigators

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

More Information
  • Responsible Party: University of Cape Town
  • ClinicalTrials.gov Identifier: NCT03920163 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Wounds and Injuries Abdominal Injuries