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

March 16, 2022 updated by: Tushar Subhadarshan Mishra, All India Institute of Medical Sciences, Bhubaneswar

Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Tushar S Mishra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Enhanced recovery after surgery group

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.
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.
ACTIVE_COMPARATOR: Conventional group

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Post operative period up-to one month.
Duration from the time of operation to time of discharge
Post operative period up-to one month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of functional parameters
Time Frame: Post operative period up-to one month.
  • Time of withdrawal of nasogastric tube (hours)
  • Time to first bowel sound (hours)
  • Time to first flatus (hours)
  • Time to first stool (hours)
  • Time to removal of drain(hours)
  • Time to first fluid diet (hours)
  • Time to first solid diet (hours)
  • Time to stoppage of IV fluids(hours)
  • Time of removal of urinary catheter (hours)
  • Time to ambulation(hours)
Post operative period up-to one month.
Post operative complications
Time Frame: Post operative period up-to three months.
  • Anastomotic leakage
  • Pneumonia
  • Ileus
  • Obstruction
  • Wound infection
  • Abdominal sepsis
  • Burst Abdomen
  • Need for reinsertion of nasogastric tube
  • Need for reinsertion of urinary catheter
  • Need for drainage of abdominal collection
  • Readmission
  • Re operation
  • Mortality
Post operative period up-to three months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life scoring and assessment
Time Frame: Post operative period - at day of discharge, at one month follow up and at third month follow up.
Quality of life assessment will be done using EQ-5D-5L questionnaire (Euroqol 5 dimensions and 5 levels). It has 2 components, descriptive and objective. Descriptive component comprises of 5 dimensions which are mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, namely no problem, slight problems, moderate problems, severe problems and extreme problems. Objective component is also called Euroqol visual analog scale. Score ranges from zero to hundred.The endpoints are labelled as 'the best health participant can imagine' and 'the worst health participant can imagine'. It will be assessed on the day of discharge, follow up at one month and follow up at third month in the post operative period.
Post operative period - at day of discharge, at one month follow up and at third month follow up.
Intra-abdominal collection
Time Frame: Post operative period-at one month and at third month in post operative period.
Ultrasonography abdomen will be done at one month to look for any intra-abdominal collection and if any collection is found, will be repeated at third month follow up.
Post operative period-at one month and at third month in post operative period.
Hematological parameter
Time Frame: Post-operative period up-at one month and at third month.
Total leukocyte count will be measured at follow up at one month.If the value is more than 11,000 cells/mm cube or less than 4000 cells/mm cube, then it will be measured again at third month of follow up.
Post-operative period up-at one month and at third month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Principal Investigator: TUSHAR S MISHRA, MBBS,MS, All India Institute of Medical Sciences, New Delhi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

May 15, 2021

Study Completion (ACTUAL)

June 15, 2021

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

December 7, 2019

First Posted (ACTUAL)

December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMS BBSR/PGT/2019-20/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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