search
Back to results

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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ERAS pathway
Standard pathway
Sponsored by
GEM Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring ERAS, Enhanced recovery after sugery in bariatric surgery, sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gem Hospital and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ERAS pathway

Standard pathway

Arm Description

Laparoscopic sleeve gastrectomy with ERAS pathway

Laparoscopic sleeve gastrectomy with standard pathway

Outcomes

Primary Outcome Measures

Hospital stay
Postoperative hospital stay of patients

Secondary Outcome Measures

Pain score
Postoperative pain score
Operative time
Time taken to perform surgery
Analgesic requirement
Post operative cumulative analgesic requirement
Complication rate
Post operative complications rate

Full Information

First Posted
June 15, 2017
Last Updated
October 20, 2018
Sponsor
GEM Hospital & Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03191318
Brief Title
Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
Acronym
BARI-ERAS
Official Title
Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GEM Hospital & Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
ERAS, Enhanced recovery after sugery in bariatric surgery, sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS pathway
Arm Type
Active Comparator
Arm Description
Laparoscopic sleeve gastrectomy with ERAS pathway
Arm Title
Standard pathway
Arm Type
Active Comparator
Arm Description
Laparoscopic sleeve gastrectomy with standard pathway
Intervention Type
Other
Intervention Name(s)
ERAS pathway
Other Intervention Name(s)
Fast track pathway
Intervention Description
ERAS pathway after laparoscopic sleeve gastrectomy
Intervention Type
Other
Intervention Name(s)
Standard pathway
Other Intervention Name(s)
Coventional pathway
Intervention Description
Standard pathway after laparoscopic sleeve gastrectomy
Primary Outcome Measure Information:
Title
Hospital stay
Description
Postoperative hospital stay of patients
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pain score
Description
Postoperative pain score
Time Frame
Within 72 hours of surgery
Title
Operative time
Description
Time taken to perform surgery
Time Frame
Within 24 hours, in minutes
Title
Analgesic requirement
Description
Post operative cumulative analgesic requirement
Time Frame
Within 72 hours
Title
Complication rate
Description
Post operative complications rate
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Palanivelu, MS, MCh
Organizational Affiliation
GEM Hospital & Research centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
P Praveen Raj, MS, DNB
Organizational Affiliation
GEM Hospital and Research centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
M S Prabhakaran, DA
Organizational Affiliation
GEM Hospital & Research centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Siddhartha Bhattacharya, MS, DNB, FNB
Organizational Affiliation
GEM Hospital & Research centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gem Hospital and Research Centre
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641045
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It may be obtained by request
Citations:
PubMed Identifier
25670530
Citation
Pimenta GP, Capellan DA, de Aguilar-Nascimento JE. Sleeve Gastrectomy With or Without a Multimodal Perioperative Care. A Randomized Pilot Study. Obes Surg. 2015 Sep;25(9):1639-46. doi: 10.1007/s11695-015-1573-2.
Results Reference
background
PubMed Identifier
23339040
Citation
Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
Results Reference
background
PubMed Identifier
32291702
Citation
Prabhakaran S, Misra S, Magila M, Kumar SS, Kasthuri S, Palanivelu C, Raj PP. Randomized Controlled Trial Comparing the Outcomes of Enhanced Recovery After Surgery and Standard Recovery Pathways in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Sep;30(9):3273-3279. doi: 10.1007/s11695-020-04585-2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs