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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Other: ERAS pathway
* Other: Standard pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERAS pathway<br>Laparoscopic sleeve gastrectomy with ERAS pathway | Other: ERAS pathway<br>* ERAS pathway after laparoscopic sleeve gastrectomy<br>* Other names: Fast track pathway;|
| Active Comparator: Standard pathway<br>Laparoscopic sleeve gastrectomy with standard pathway | Other: Standard pathway<br>* Standard pathway after laparoscopic sleeve gastrectomy<br>* Other names: Coventional pathway;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Enhanced recovery after sugery in bariatric surgery, sleeve gastrectomy