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Enhanced Recovery After Trauma Surgery

Enhanced Recovery After Trauma Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03920163
Acronym
ERATS
Enrollment
102
Registered
2019-04-18
Start date
2019-03-29
Completion date
2022-12-31
Last updated
2022-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penetrating Abdominal Trauma

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.

Interventions

OTHEREnhanced Recovery Measures

Perioperative measures

Sponsors

University of Cape Town
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay7 daysDuration of admission to the hospital

Secondary

MeasureTime frameDescription
Early removal of Nasogastric tubes, urinary catheters ,drains7 daysDays to complete ambulation
Comparative mortality between the control and ERATS group30 days30 day mortality
Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively7 daysComparative daily pain score evaluation with Visual Analogue Score between control and ERATS group
Early feeding post explorative laparotomy7 daysDays to tolerating full ward diet
Cost comparative between the 2 groups30 daysAverage cost between the 2 groups based on days in hospital , medication and consumables used
Morbidity in control group compared to ERATS group30 daysPost operative surgical complications will be graded according to the extended Clavien-Dindo scoring system
Benefit of early mobilization post exploratory laparotomy7 daysTime taken to return to normal activities of daily living, complete ambulation

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026