Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy (BARI-ERAS)

October 20, 2018 updated by: GEM Hospital & Research Center

Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy

The aim of this study is to compare two postoperative recovery pathways namely, enhanced recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and other postoperative outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Enhanced recovery after surgery (ERAS) pathway, initially introduced for colorectal surgery, is an evidence based perioperative pathway which has resulted in earlier recovery, less pain, and lower complication rates. Bariatric surgical patients, without severe co-morbidities, are good candidates for ERAS pathway, but the application of ERAS concepts has been limited in this field, specially, in Asia.

Although the current literature shows that 2 randomized clinical trials (RCT) have been performed for application of ERAS in bariatric surgery, data is still scarce as per outcomes with respect to postoperative pain and analgesic usage. One of the RCTs has compared with historical controls and both the RCTs have not clearly defined their conventional standard pathways. In this study, the investigators have clearly defined both ERAS pathway and standard pathway leaving no ambiguity.

This study is a prospective, randomized, parallel group trial comparing ERAS pathway and standard pathway after laparoscopic sleeve gastrectomy in relation to the hospital stay, postoperative pain, complications and other perioperative parameters.

This is a single institute based trial, being conducted at GEM hospital and research centre, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

In this trial, the investigators are planning to enroll participants with morbid obesity planned to undergo laparoscopic sleeve gastrectomy. After full assessment, informed consent, these participants will be randomised using computer generated random numbers either into ERAS pathway group or into Standard pathway group.

All the intraoperative and perioperative details with respect to anaesthetic drugs usage, intravenous fluid requirement, time to ambulation, time to oral liquids, postoperative pain score, analgesic requirement and hospital stay will be recorded in the proforma.

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
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641045
        • Gem Hospital and Research Centre

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing laparoscopic sleeve gastrectomy during this study period

Exclusion Criteria:

  • 1. Redo procedures 2. ASA III and above status 3. Previous major upper abdominal surgeries 4. Not willing to participate

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ERAS pathway
Laparoscopic sleeve gastrectomy with ERAS pathway
Other: ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
Other Names:
  • Fast track pathway
Active Comparator: Standard pathway
Laparoscopic sleeve gastrectomy with standard pathway
Other: Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy
Other Names:
  • Coventional pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 7 days
Postoperative hospital stay of patients
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Within 72 hours of surgery
Postoperative pain score
Within 72 hours of surgery
Operative time
Time Frame: Within 24 hours, in minutes
Time taken to perform surgery
Within 24 hours, in minutes
Analgesic requirement
Time Frame: Within 72 hours
Post operative cumulative analgesic requirement
Within 72 hours
Complication rate
Time Frame: Within 30 days
Post operative complications rate
Within 30 days

Collaborators and Investigators

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

Sponsor

GEM Hospital & Research Center

Investigators

  • Study Chair: C Palanivelu, MS, MCh, GEM Hospital & Research centre
  • Study Director: P Praveen Raj, MS, DNB, Gem Hospital and Research Centre
  • Principal Investigator: M S Prabhakaran, DA, GEM Hospital & Research centre
  • Principal Investigator: Siddhartha Bhattacharya, MS, DNB, FNB, GEM Hospital & Research centre

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)

September 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 20, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BARI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It may be obtained by request

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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