Comparison of adapted Enhanced Recovery After Surgery (ERAS) pathway versus standard care in patients undergoing emergency abdominal surgery – a randomized controlled trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Length of hospitalization.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Length of hospitalization.
Time Frame: 4 days to 2-3 weeks
Secondary Outcomes
- 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)