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

Phase 3

• Conditions: Postoperative Pain
• Interventions: Combination Product: ERAS protocol; Combination Product: Standard care

• 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

Arm && Interventions

Group	Intervention	Description
ERAS protocol	ERAS protocol	ERAS protocol includes early oral intake (6 hours after surgery), early deambulation (6h after surgery) and multimodal analgesia (port-sites infiltration with Bupivacain 0.5% combined with postoperative intravenous analgesia)
Standard care	Standard care	Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs

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