Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 postoperative-pain
Started Mar 2016
Typical duration for phase_3 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 11, 2017
July 1, 2017
1.8 years
June 29, 2017
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Evaluated by Visual Analogic Scale
24 hours after surgery
Secondary Outcomes (1)
Hospital stay
Days until patients´discharge: 2 days or more than 2 days
Study Arms (2)
ERAS protocol
EXPERIMENTALERAS 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
ACTIVE COMPARATOROral intake and early deambulation begins 24h after surgery and analgesia consists in only intravenous drugs
Interventions
ERAS protocol includes early oral intake and deambulation and multimodal analgesia
Oral intake and deambulation 24h after surgery and only intravenous analgesia.
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) \>40 Kg/m2
- BMI \>35 Kg/m2 with obesity-associated comorbidities
You may not qualify if:
- Patients undergoing other bariatric procedures
- Patients undergoing bariatric revisional surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital Elche
Elche, Alicante, 03203, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Manuel Duran
Hospital Rey Juan carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Nurse evaluating postoperative pain is blinded to the protocol applied
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Department
Study Record Dates
First Submitted
June 29, 2017
First Posted
July 11, 2017
Study Start
March 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
July 11, 2017
Record last verified: 2017-07