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NCT03212573 Clinical Trial

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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03212573
Other study ID # HRJC17/18
Secondary ID
Status Recruiting
Phase Phase 3
First received June 29, 2017
Last updated July 7, 2017
Start date March 1, 2016
Est. completion date December 2017

Study information
Verified date July 2017
Source Hospital General Universitario Elche
Contact Jaime Ruiz-Tovar
Phone 0034630534808
Email jruiztovar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• ERAS protocol
ERAS protocol includes early oral intake and deambulation and multimodal analgesia
• Standard care
Oral intake and deambulation 24h after surgery and only intravenous analgesia.

Locations
Country Name City State
Spain General Hospital Elche Elche Alicante

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain Evaluated by Visual Analogic Scale 24 hours after surgery
Secondary Hospital stay Days Days until patients´discharge: 2 days or more than 2 days
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