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临床试验/CTRI/2019/02/017537
CTRI/2019/02/017537尚未招募不适用

Comparison of adapted enhanced recovery after surgery pathway vs. standard care in patients undergoing emergency laparotomy for perforation peritonitis- A Randomized controlled trial

Jawaharlal Institute of Postgraduate Medical Education Research Government of India1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Lenth of hospital stay

研究概览

简要总结

Emergency laparotomies constitute majority of the

emergency surgical operations amongst which surgeries done for small bowel

pathologies account for 22 % to 33 % of the cases.Postoperative mortality rates

of 10-14 % have been reported following emergency procedures for small

bowel pathology in India.This indicates the dire need for revising the

perioperative care practices in the emergency setting. Enhanced Recovery After Surgery (ERAS) pathway, is an integrated

care pathway that utilizes multimodal evidence based approach to optimize patient’s

recovery.The purpose of these pathways is to use current evidence in a streamlined

multidisciplinary manner with the aim of minimizing surgical pain and enhancing

recovery, leading to fewer complications, more rapid hospital discharge and improved

overall outcomes.

The applicability of ERAS pathways has been tested in numerous elective procedures

but there is a dearth in the studies conducted in an emergency setting. Hence this study is planned to assess the feasibility of ERAS in patients undergoing

emergency surgery for perforation peritonitis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •All consecutive patients above 18 years of age, who present to the emergency surgical team with perforation peritonitis, diagnosed based on clinical examination and adjunct investigations and planned for emergency laparotomy after volume resuscitation.

排除标准

  • •1.Age less than 18 years
  • •Uncontrolled comorbid diseases.
  • •Localized peritonitis
  • •American Society of Anesthesiologists physical status class 4E
  • •Patients with coagulopathy (INR .1.5 and platelet count < 1 lakh)
  • •Patients on vasopressor or ventilator support
  • •Septic shock
  • •Associated psychiatric or neurological illnesses
  • •Pregnant patients
  • •Polytrauma patients with associated other intraabdominal organ injury.

结局指标

主要结局

Lenth of hospital stay

时间窗: from 4 days upto 2-3 weeks

次要结局

  • To identify risk factors which are responsible for delayed discharge/ failure of(ERAS)
  • Time elapsed until resumption of oral feeding(ï‚· Time for removal of nasogastric tube, drains and catheter)

研究者

发起方
Jawaharlal Institute of Postgraduate Medical Education Research Government of India
申办方类型
Research institution and hospital

研究点 (1)

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