An interventional study of Enhanced Recovery Measures in Penetrating Abdominal Trauma, sponsored by University of Cape Town. Status unknown at 1 site in South Africa. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-09.
Sponsored by University of Cape Town · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 102 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Cape Town is the lead sponsor of 109 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care
Other: Enhanced Recovery Measures
Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .
Other: Enhanced Recovery Measures
Perioperative measures
Length of hospital stay
Duration of admission to the hospital
Time frame: 7 days
Early feeding post explorative laparotomy
Days to tolerating full ward diet
Time frame: 7 days
Early removal of Nasogastric tubes, urinary catheters ,drains
Days to complete ambulation
Time frame: 7 days
Comparative mortality between the control and ERATS group
30 day mortality
Time frame: 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
Time frame: 7 days
Benefit of early mobilization post exploratory laparotomy
Time taken to return to normal activities of daily living, complete ambulation
Time frame: 7 days
Cost comparative between the 2 groups
Average cost between the 2 groups based on days in hospital , medication and consumables used
Time frame: 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
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
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University of Cape Town