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

Morbid Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191318
• Other study ID #: BARI-01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2018
• Source: GEM Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Other:
• ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
• Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
India	Gem Hospital and Research Centre	Coimbatore	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
GEM Hospital & Research Center

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital stay	Postoperative hospital stay of patients	7 days
Secondary	Pain score	Postoperative pain score	Within 72 hours of surgery
Secondary	Operative time	Time taken to perform surgery	Within 24 hours, in minutes
Secondary	Analgesic requirement	Post operative cumulative analgesic requirement	Within 72 hours
Secondary	Complication rate	Post operative complications rate	Within 30 days