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临床试验/NCT03920163
NCT03920163进行中(未招募)不适用

Enhanced Recovery After Trauma Surgery

University of Cape Town2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
102
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Penetrating abdominal trauma
  • Require emergency laparotomy
  • Alert ( Glasgow Coma Scale - 15/15)
  • Able to consent
  • Hemodynamically stable

排除标准

  • 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

结局指标

主要结局

Length of hospital stay

时间窗: 7 days

Duration of admission to the hospital

次要结局

  • Early feeding post explorative laparotomy(7 days)
  • Local aneasthetic wound infusion catheter system inserted in the laparotomy wound post procedure compared to standard opiate intravenous infusions used post operatively(7 days)
  • Benefit of early mobilization post exploratory laparotomy(7 days)
  • Early removal of Nasogastric tubes, urinary catheters ,drains(7 days)
  • Comparative mortality between the control and ERATS group(30 days)
  • Cost comparative between the 2 groups(30 days)
  • Morbidity in control group compared to ERATS group(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr DEK McPherson

Principal Investigator

University of Cape Town

研究点 (2)

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