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Trial record 3 of 5911 for:    PATHway

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03191318
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
GEM Hospital & Research Center

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Other: ERAS pathway Other: Standard pathway Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ERAS pathway
Laparoscopic sleeve gastrectomy with ERAS pathway
Other: ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
Other Name: Fast track pathway

Active Comparator: Standard pathway
Laparoscopic sleeve gastrectomy with standard pathway
Other: Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy
Other Name: Coventional pathway




Primary Outcome Measures :
  1. Hospital stay [ Time Frame: 7 days ]
    Postoperative hospital stay of patients


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Within 72 hours of surgery ]
    Postoperative pain score

  2. Operative time [ Time Frame: Within 24 hours, in minutes ]
    Time taken to perform surgery

  3. Analgesic requirement [ Time Frame: Within 72 hours ]
    Post operative cumulative analgesic requirement

  4. Complication rate [ Time Frame: Within 30 days ]
    Post operative complications rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191318


Locations
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India
Gem Hospital and Research Centre
Coimbatore, Tamil Nadu, India, 641045
Sponsors and Collaborators
GEM Hospital & Research Center
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GEM Hospital & Research Center
ClinicalTrials.gov Identifier: NCT03191318    
Other Study ID Numbers: BARI-01
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It may be obtained by request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GEM Hospital & Research Center:
ERAS
Enhanced recovery after sugery in bariatric surgery
sleeve gastrectomy
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms