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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03212573

Enrollment

180

Registered

2017-07-11

Start date

2016-03-01

Completion date

2017-12-31

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

COMBINATION_PRODUCTERAS protocol

ERAS protocol includes early oral intake and deambulation and multimodal analgesia

COMBINATION_PRODUCTStandard care

Oral intake and deambulation 24h after surgery and only intravenous analgesia.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Masking description

Nurse evaluating postoperative pain is blinded to the protocol applied

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain	24 hours after surgery	Evaluated by Visual Analogic Scale

Secondary

Measure	Time frame	Description
Hospital stay	Days until patients´discharge: 2 days or more than 2 days	Days

Countries

Spain

Contacts

Primary ContactJaime Ruiz-Tovar

jruiztovar@gmail.com0034630534808

Backup ContactAlejandro Garcia

alegarmuna@gmail.com0034656431921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026