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Status unknownNCT03920163ERATSUpdated Dec 9, 2022

Enhanced Recovery After Trauma Surgery

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

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Penetrating Abdominal Trauma
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In context

Wounds and Injuries

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 →

Lead sponsor

University of Cape Town is the lead sponsor of 109 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    Control

    Stable , penetrating trauma patients undergoing laparotomy who receive standard post operative care

    Other: Enhanced Recovery Measures

  • Experimental
    ERATS

    Stable penetrating trauma patients undergoing laparotomy who receive enhanced recovery measures post operatively .

    Other: Enhanced Recovery Measures

Interventions

  • OtherEnhanced Recovery Measures

    Perioperative measures

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What researchers measure

Primary outcomes

  1. Length of hospital stay

    Duration of admission to the hospital

    Time frame: 7 days

Secondary outcomes

  1. Early feeding post explorative laparotomy

    Days to tolerating full ward diet

    Time frame: 7 days

  2. Early removal of Nasogastric tubes, urinary catheters ,drains

    Days to complete ambulation

    Time frame: 7 days

  3. Comparative mortality between the control and ERATS group

    30 day mortality

    Time frame: 30 days

  4. 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

  5. Benefit of early mobilization post exploratory laparotomy

    Time taken to return to normal activities of daily living, complete ambulation

    Time frame: 7 days

  6. 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

  7. 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

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Study locations

1 site
  • Groote Schuur Hospital
    Cape Town, Western Vape 7925, South Africa
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03920163
Lead sponsor
University of Cape Town
Responsible party
Dr DEK McPherson (Principal Investigator, University of Cape Town) — Principal investigator
First posted
Apr 18, 2019
Start date
Mar 29, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Dec 9, 2022

Study contacts

Andrew Nicol, FCS(SA)
study director · University of Cape Town

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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