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

NCT03191318 | Completed DMC

• 1 other identifier: BARI-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

ERAS; Enhanced recovery after sugery in bariatric surgery; sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  Postoperative hospital stay of patients

  7 days

Secondary Outcomes (4)

• Pain score

  Within 72 hours of surgery

• Operative time

  Within 24 hours, in minutes

• Analgesic requirement

  Within 72 hours

• Complication rate

  Within 30 days

Study Arms (2)

ERAS pathway

ACTIVE COMPARATOR

Laparoscopic sleeve gastrectomy with ERAS pathway

Other: ERAS pathway

Standard pathway

ACTIVE COMPARATOR

Laparoscopic sleeve gastrectomy with standard pathway

Other: Standard pathway

Interventions

ERAS pathway OTHER

ERAS pathway after laparoscopic sleeve gastrectomy

Also known as: Fast track pathway

ERAS pathway

Standard pathway OTHER

Standard pathway after laparoscopic sleeve gastrectomy

Also known as: Coventional pathway

Standard pathway

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing laparoscopic sleeve gastrectomy during this study period

You may not qualify if:

• \. Redo procedures 2. ASA III and above status 3. Previous major upper abdominal surgeries 4. Not willing to participate

Sponsors & Collaborators

• GEM Hospital & Research Center: lead

Study Sites (1)

Gem Hospital and Research Centre

Coimbatore, Tamil Nadu, 641045, India

Location

Related Publications (3)

• 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.

  PMID: 25670530 BACKGROUND

• 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.

  PMID: 23339040 BACKGROUND

• 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.

  PMID: 32291702 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• C Palanivelu, MS, MCh

  GEM Hospital & Research centre

  STUDY CHAIR

• P Praveen Raj, MS, DNB

  GEM Hospital and Research centre

  STUDY DIRECTOR

• M S Prabhakaran, DA

  GEM Hospital & Research centre

  PRINCIPAL INVESTIGATOR

• Siddhartha Bhattacharya, MS, DNB, FNB

  GEM Hospital & Research centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: September 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)