Comparison of adapted Enhanced Recovery After Surgery (ERAS) pathway versus standard care in patients undergoing emergency abdominal surgery – a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Length of hospitalization.
研究概览
简要总结
Bowel surgeries, particularly needing intestinal anastomosis have conventionally been managed by prolonged abstinence from oral intake, usage of opioid analgesics, insertion of nasogastric tube and urinary catheter etc.Enhanced Recovery AfterSurgery (ERAS) pathway, is an integrated multidisciplinary pathway whichutilizes multimodal evidence-based approach to decrease perioperative surgicalstress, sustain postoperative physiological function and facilitate recovery insurgical patients.
The applicability ofERAS pathways has been tested in numerous elective procedures but there is adearth in the studies conducted in an emergency setting.The ERAS pathway hasbeen successfully implemented and has been found to be safe and effective inpatients undergoing emergency small bowel surgeries and perforated duodenalulcer surgeries in our Institute.But there are very fewreports evaluating the role of ERAS in emergency laparotomies for all cases ofabdominal surgeries.
Hence, this study isbeing carried out to investigate the feasibility and efficacy of ERAS pathwaysin patients undergoing emergency abdominal surgery.If found feasible andsafe with shorter length of hospitalization (LOH), the adapted ERAS pathway may be uniformly implemented inall emergency abdominal surgeries.
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, who present to the emergency surgi-cal team for emergency abdominal surgery, diagnosed based on clinical examination and adjunct investigations and planned for emergency laparotomy after volume resuscitation.
排除标准
- •1.Age<18 years 2.Uncontrolled comorbid diseases.
- •3.Localized peritonitis 4.Duodenal ulcer perforation 5.American Society of Anesthesiologists physical status class 4E 6.Patients with coagulopathy (INR more than 1.5 and platelet count < 1 lakh) 7.Patients on vasopressor or ventilator support 8.Septic shock 9.Associated psychiatric or neurological illnesses 10.Pregnant patients 11.Polytrauma patients with associated non abdominal in-juries.
- •12.Patients undergoing multi visceral resection.
结局指标
主要结局
Length of hospitalization.
时间窗: 4 days to 2-3 weeks
次要结局
- time to first fluid diet and first solid diet(oral sips by 6 hrs and escalation to clear liquids by 12 hrs and liquid diet by 24 hrs in ERAS (study arm))
- Time of drain removal(The abdominal drain, if any, will be withdrawn when the drainage is less than 100 ml/day irrespective of resumption of oral feeds.)
- Time of nasogastric tube removal(when the drain is less than 300ml/day)
- duration of ileus and time to first bowel sound(6 hrs in ERAS (study) arm vs more than 6 hrs in Control arm)
- Time of removal of urinary catheter(when urine output is adequate for 24 hrs)
- Time for mobilization(day 1 to 2-3 weeks)