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临床试验/CTRI/2024/02/062587
CTRI/2024/02/062587尚未招募3 期

Enhanced recovery after surgery(ERAS) vs. standard care in patients undergoing emergency laparotomy following trauma: a randomised control trial

Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月18日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Length of hospitalization

研究概览

简要总结

Trauma is increasing at an alarming rate. In India alone, it is estimated that one million people die and 20 million are hospitalized every year due to injuries4. Besides the burden of disease attributes to prolonged hospital stay and delayed return to routine activities5.

 An institutional study done by Mohammad Gad et al, had shown higher incidence of blunt trauma abdomen among trauma patients of 69.4% with around 28.3 % requiring surgical intervention6. An Indian based study also has shown higher incidence of abdominal trauma of about 73 %7. Added to this the post operative care of trauma patients undergoing surgery is of varied complexity attributed to wide range of pain manifestation and analgesics, complications due to other injuries, bleeding, nutrition, immobilization, high risk of thromboembolic events8.

Patients presenting at emergency department need varied services according to their condition at presentation which may range from hemodynamically stable to patients with failure and shock. Majority of deaths in blunt trauma is as a result of secondary hypovolemic shock due to intraperitoneal bleed which occur in 12% of patients9. Therefore, it is essential to identify trauma quickly.  FAST (focused assessment with sonography in trauma) had evolved as an noninvasive tool in place of diagnostic peritoneal lavage as a preliminary investigative step to assess the intra peritoneal pathology due to trauma especially in unstable patients10. Contrast enhanced CT is more definitive to evaluate blunt trauma, in relatively stable patients11. The objective is rapid identification of those patients who need a laparotomy.

Evaluation of blunt trauma abdomen starts from stabilization of the patients followed by the assessment. Clinical assessment of patients with blunt abdominal trauma is often difficult and can be inaccurate. The most reliable signs and symptoms in alert patients are Pain, Tenderness, Gastrointestinal haemorrhage, hypovolemia, evidence of peritoneal irritation. Besides on physical examination, the following injury patterns predict the potential for intra-abdominal trauma include marks and contusions, ecchymosis, abdominal distension, local or generalised tenderness, guarding and rigidity or rebound tenderness, fullness on palpation, crepitations or instability of lower thoracic cage12.

Patients who are haemodynamically decompensated with a positive Focused Assessment with Sonography for Trauma (FAST) should proceed directly to a trauma laparotomy to stop major abdominal bleeding and, if applicable, other sources of bleeding (e.g., pelvic, or long bone fractures), as well as control spillage of intestinal contents. To emphasise that time is a crucial factor that with every 3 min spent in the emergency department equate to a 1% increased death probability and as a result of which trauma laparotomies tend to be mandated based on quality assessment13.

The various classifications used to grade the severity of the injured organs with the organ injury scale include the American Association for the Surgery of Trauma (A. A. S. T.) 14, World society of emergency surgery (WSES) grading13,

The various surgical procedures commonly performed in abdominal surgery due to trauma include splenectomy, partial resection of the liver, vascular repair, resection and anastomosis of bowel, colostomy, distal pancreatectomy, and nephrectomy. The most frequent postoperative morbidities related to blunt abdominal trauma in the patients who survived the initial operation were prolonged ventilatory support, high dose analgesics including opioids, nil per oral, strict bed rest, prolonged urinary catheterization, central and peripheral vascular access, multiple blood transfusions and associated transfusion reactions, wound infection, pulmonary infection, intra-abdominal abscesses, pancreatitis15.

Various modalities are being under study to improve quality care among patients undergoing trauma surgery. ERAS is one such quality care protocol under wide use in elective surgical procedures and have been shown to lead to a reduction in hospital stay, complications and earlier resumption of normal activities16.

There is well documented evidence in the literature regarding applicability of ERAS pathways in elective bowel surgeries and have been shown to lead to a reduction in hospital stay, complications and earlier resumption of normal activities.

Multiple RCTs and meta-analysis have been done supporting the fact that in patients undergoing elective bowel surgery, early feeding is safe, well tolerated and decreases the hospital stay.

In a study done by V Purushothaman et al have shown that ERAS is safe and feasible in trauma surgery with similar complication rate. There are no other similar studies to the best of our knowledge17. Hence, this study is being done to investigate role of ERAS in emergency abdominal surgeries due to trauma.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA (American Society of Anesthesiologists) physical status I and II
  • Adequate cognitive capacity.

排除标准

  • 未提供

结局指标

主要结局

Length of hospitalization

时间窗: Length of hospitalization

次要结局

  • Time to first flatus and stools(hospitalization)
  • 2. Time to removal of drainage tubes (nasogastric tube, urinary catheter, abdominal drainage tube)(hospitalization)
  • Time to resumption of oral feeds (fluids and solid diet)(hospitalization)
  • Need for Nasogastric tube insertion(hospitalization)
  • Need for additional intravenous opiod analgesics(hospitalization)
  • Complications (Measured by Clavien-Dindo classification)(hospitalization)
  • 30 days Mortality and readmission rates(30days postop)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Deepak Sharma

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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