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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Other: ERAS pathway; Other: Standard pathway

• Registration Number: NCT03191318
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2017-09-01
• Primary Completion: 2018-07-01
• Study Completion: 2018-08-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-20
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS pathway	ERAS pathway	Laparoscopic sleeve gastrectomy with ERAS pathway
Standard pathway	Standard pathway	Laparoscopic sleeve gastrectomy with standard pathway

Primary Outcome Measures

Name	Time	Method
Hospital stay	7 days	Postoperative hospital stay of patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gem Hospital and Research Centre; 🇮🇳 Coimbatore, Tamil Nadu, India