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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences, Bhubaneswar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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