Enhanced Recovery After Trauma Surgery

NCT03920163 | Unknown DMC

• 1 other identifier: ERATS
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Penetrating Abdominal Trauma

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Duration of admission to the hospital

  7 days

Secondary Outcomes (7)

• Early feeding post explorative laparotomy

  7 days

• Early removal of Nasogastric tubes, urinary catheters ,drains

  7 days

• Comparative mortality between the control and ERATS group

  30 days

• Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively

  7 days

• Benefit of early mobilization post exploratory laparotomy

  7 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Enhanced Recovery Measures

ERATS

EXPERIMENTAL

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

Other: Enhanced Recovery Measures

Interventions

Enhanced Recovery Measures OTHER

Perioperative measures

Control; ERATS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Vape, 7925, South Africa

Location

Study Officials

• Andrew Nicol, FCS(SA)

  University of Cape Town

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 18, 2019
• Study Start: March 29, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)