Penetrating Abdominal TraumaERATSNCT03920163
Enhanced Recovery After Trauma Surgery
A study testing Enhanced Recovery Measures in people with Penetrating Abdominal Trauma, run by University of Cape Town at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Penetrating Abdominal Trauma
- What is being tested?
- Enhanced Recovery Measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSouth Africa
- Study dates
- 29 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years
- Penetrating abdominal trauma
- Require emergency laparotomy
- Alert ( Glasgow Coma Scale - 15/15)
- Able to consent
- Hemodynamically stable
Who cannot join
- 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
Show all 9Show fewer
- All Duodenal injuries
- All Bladder injuries
- Previous laparotomies
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read more
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
- Being tested
- Enhanced Recovery Measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery MeasuresOther
Perioperative measures
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care Receives: Other: Enhanced Recovery Measures |
| ERATS | Experimental | Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively . Receives: Other: Enhanced Recovery Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration of admission to the hospital
Measured: 7 days
Secondary outcomes (7)
Early feeding post explorative laparotomy
Days to tolerating full ward diet
Measured: 7 days
Early removal of Nasogastric tubes, urinary catheters ,drains
Days to complete ambulation
Measured: 7 days
Comparative mortality between the control and ERATS group
30 day mortality
Measured: 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
Measured: 7 days
Benefit of early mobilization post exploratory laparotomy
Time taken to return to normal activities of daily living, complete ambulation
Measured: 7 days
Cost comparative between the 2 groups
Average cost between the 2 groups based on days in hospital , medication and consumables used
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start29 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Abdominal TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr DEK McPherson, University of Cape Town
- Investigators
- Andrew Nicol, FCS(SA), Study director, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920163
- Sponsor's protocol ID
- ERATS
- Acronym
- ERATS
- Status last verified
- Dec 2022
- First submitted
- 5 Apr 2019
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Trauma Surgery
- ClinicalTrials.gov ID
- NCT03920163
- Acronym / sponsor ID
- ERATS / ERATS
- Conditions
- Penetrating Abdominal Trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Enhanced Recovery MeasuresStable , penetrating trauma patients undergoing laparotomy who receive standard post operative care |
| ERATS | Experimental | Other: Enhanced Recovery MeasuresStable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years
- Penetrating abdominal trauma
- Require emergency laparotomy
- Alert ( Glasgow Coma Scale - 15/15)
- Able to consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery MeasuresPerioperative measures | Other | Control, ERATS |
Primary outcome
Length of hospital stay
Time frame: 7 days
Duration of admission to the hospital
7 secondary outcomes
Early feeding post explorative laparotomy
Time frame: 7 days
Early removal of Nasogastric tubes, urinary catheters ,drains
Time frame: 7 days
Comparative mortality between the control and ERATS group
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
Time frame: 7 days
Benefit of early mobilization post exploratory laparotomy
Time frame: 7 days
Cost comparative between the 2 groups
Time frame: 30 days
Morbidity in control group compared to ERATS group
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Nicol, FCS(SA) study director
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery Measures in people with Penetrating Abdominal Trauma, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.