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

NCT ID: NCT03212573

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Nurse evaluating postoperative pain is blinded to the protocol applied

Study Groups

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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)

Group Type EXPERIMENTAL

ERAS protocol

Intervention Type COMBINATION_PRODUCT

ERAS protocol includes early oral intake and deambulation and multimodal analgesia

Standard care

Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type COMBINATION_PRODUCT

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

Interventions

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ERAS protocol

ERAS protocol includes early oral intake and deambulation and multimodal analgesia

Intervention Type COMBINATION_PRODUCT

Standard care

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Duran

Role: STUDY_CHAIR

Hospital Rey Juan carlos

Locations

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General Hospital Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jaime Ruiz-Tovar

Role: CONTACT

0034630534808

Alejandro Garcia

Role: CONTACT

0034656431921

Facility Contacts

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Jaime Ruiz-Tovar

Role: primary

(0034)630534808

Other Identifiers

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HRJC17/18

Identifier Type: -

Identifier Source: org_study_id

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