Enhanced Recovery After Trauma Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Enhanced Recovery After Trauma Surgery

Conditions
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Penetrating Abdominal Trauma

Intervention / Treatment
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* Other: Enhanced Recovery Measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |