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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03920163
Other study ID # ERATS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 29, 2019
Est. completion date December 31, 2022

Study information

Verified date December 2022
Source University of Cape Town
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 102
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Enhanced Recovery Measures
Perioperative measures

Locations

Country Name City State
South Africa Groote Schuur Hospital Cape Town Western Vape

Sponsors (1)

Lead Sponsor Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay Duration of admission to the hospital 7 days
Secondary Early feeding post explorative laparotomy Days to tolerating full ward diet 7 days
Secondary Early removal of Nasogastric tubes, urinary catheters ,drains Days to complete ambulation 7 days
Secondary Comparative mortality between the control and ERATS group 30 day mortality 30 days
Secondary 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
Secondary Benefit of early mobilization post exploratory laparotomy Time taken to return to normal activities of daily living, complete ambulation 7 days
Secondary Cost comparative between the 2 groups Average cost between the 2 groups based on days in hospital , medication and consumables used 30 days
Secondary 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
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