Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass

Phase 3

• Conditions: Postoperative Pain

• Registration Number: NCT03212573
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol.

Postoperative pain 24 hours after surgery and hospital stay will be assessed.

Detailed Description

A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia).

Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-06-29
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Body Mass Index (BMI) >40 Kg/m2
• BMI >35 Kg/m2 with obesity-associated comorbidities

Exclusion Criteria

• Patients undergoing other bariatric procedures
• Patients undergoing bariatric revisional surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours after surgery	Evaluated by Visual Analogic Scale

Secondary Outcome Measures

Name	Time	Method
Hospital stay	Days until patients´discharge: 2 days or more than 2 days	Days

Trial Locations

Locations (1)

General Hospital Elche; 🇪🇸 Elche, Alicante, Spain