MedTrace Logo

ERAS vs Conventional Approach in Peptic Perforation-RCT

NCT04194060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-18

No results posted yet for this study

Summary

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.

Conditions

  • Peptic Ulcer Perforation
  • Perforated Bowel
  • Post-Op Complication
  • Emergencies
  • Perioperative Complication

Interventions

COMBINATION_PRODUCT

Enhanced Recovery after Surgery group

* Tracheal intubation and with General anesthesia * 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.

COMBINATION_PRODUCT

Conventional

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • TUSHAR S MISHRA, MBBS,MS · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-05-15
Completion
2021-06-15

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04194060 on ClinicalTrials.gov