ERAS vs Conventional Approach in Peptic Perforation-RCT (ERASE)

All India Institute of Medical Sciences, Bhubaneswar

Status: Completed

Conditions: Perioperative Complication; Emergencies; Post-Op Complication; Perforated Bowel; Peptic Ulcer Perforation

Treatments: Combination Product: Enhanced Recovery after Surgery group; Combination Product: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT04194060

AIIMS BBSR/PGT/2019-20/65

Details and patient eligibility

About

This study compares 2 different ways of perioperative management in patients of peptic perforation. Experimental arm is the ERAS arm( Enhanced recovery after surgery) and the comparative arm is Conventional arm.

Full description

While the conventional approach to perioperative management can potentially prolong the post operative hospital stay, ERAS(Enhanced recovery after surgery), a multi-modal and multispeciality approach to perioperative management may reduce the length of hospital stay. In the preoperative period, patients will be counselled regarding the operative procedure and particulars of the perioperative management.In the intra-operative period short acting general anesthetic agents and short acting muscle relaxants will be used.Intravenous fluid administration will be goal directed. After the operative procedure, bilateral rectus sheath block will be administered. Patient will also receive post-operative nausea and vomiting prophylaxis. Nasogastric tube will be removed immediately after the operative procedure. In the post operative period, patients will be encouraged to ambulate early. Enteral nutrition will be initiated as early as possible. Indwelling catheters will be removed in the early post-operative procedure.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patient diagnosed with peptic perforation intra -operatively
2. Perforation of size <=1 cm
3. Patient age more than 18 years
4. American Society of Anesthesiologists score of I or II

Exclusion criteria

1. Refractory septic shock at presentation.

2. Known Chronic kidney disease/ Chronic liver disease patients

3. Pregnant patients.

4. Patients with history of chronic steroid abuse.

5. Intraoperatively

   • Patient with coexistent peptic perforation with bleeding ulcer.
   • Peptic perforation requiring procedure other than Omental patch repair.
   • Sealed perforations.
   • Malignant perforation.

6. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.

7. Patient requiring urinary catheterization for other indications.

8. Coexistent neurological or psychiatric illness or unable to understand the study.

9. Patient refusing for consent.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Enhanced recovery after surgery group

Experimental group

Description:

ERAS GROUP * Tracheal intubation. * Short acting anesthetic agents,avoid opioid agents * Omental patch repair with placement of sub hepatic drain * Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery. * Post operative nausea and vomiting prophylaxis. * Encourage to mobilize out of bed after effect of general anesthesia has weaned off. * Initiation of feeding-Oral sips on day 1, step up day 2 onward * Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube. * Removal of urinary catheter-after weaning from the effect of general anesthesia. * Sub hepatic drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus. * Avoid opiod analgesics.

Treatment:

Combination Product: Enhanced Recovery after Surgery group

Conventional group

Active Comparator group

Description:

CONVENTIONAL GROUP * Tracheal intubation * Short acting anesthetic agents, avoid opiod anesthesia agents. * Omental patch repair along with sub hepatic drain placement. * Post operative nausea and vomiting prophylaxis. * Ambulation-as per patients' own request. * Initiation of oral feed- after passage of 1st flatus. * Nasogastric tube removal-output \<300ml/day with resolution of ileus. * Removal of urinary catheter- when patient sits on bed side/ambulate. * Removal of sub hepatic drain-when patient tolerates unrestricted amount of liquid diet and drain output is less than 200 ml /day. * Patient will receive opiod analgesics. I

Treatment:

Combination Product: Conventional