Back to resultsImpact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
ERAS protocol
Standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- General Hospital ElcheRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ERAS protocol
Standard care
Arm Description
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)
Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs
Outcomes
Primary Outcome Measures
Postoperative pain
Evaluated by Visual Analogic Scale
Secondary Outcome Measures
Hospital stay
Days
Full Information
NCT ID
NCT03212573
First Posted
June 29, 2017
Last Updated
July 7, 2017
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT03212573
Brief Title
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
Official Title
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Nurse evaluating postoperative pain is blinded to the protocol applied
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ERAS protocol
Arm Type
Experimental
Arm Description
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)
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Oral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs
Intervention Type
Combination Product
Intervention Name(s)
ERAS protocol
Intervention Description
ERAS protocol includes early oral intake and deambulation and multimodal analgesia
Intervention Type
Combination Product
Intervention Name(s)
Standard care
Intervention Description
Oral intake and deambulation 24h after surgery and only intravenous analgesia.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Evaluated by Visual Analogic Scale
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Days
Time Frame
Days until patients´discharge: 2 days or more than 2 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ruiz-Tovar
Phone
0034630534808
Email
jruiztovar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Garcia
Phone
0034656431921
Email
alegarmuna@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Duran
Organizational Affiliation
Hospital Rey Juan carlos
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Phone
(0034)630534808
Email
jruiztovar@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
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