Clinical Trials Directory

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UnknownNCT03212573

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

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Hospital General Universitario Elche · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTERAS protocolERAS protocol includes early oral intake and deambulation and multimodal analgesia
COMBINATION_PRODUCTStandard careOral intake and deambulation 24h after surgery and only intravenous analgesia.

Timeline

Start date
2016-03-01
Primary completion
2017-12-01
Completion
2017-12-01
First posted
2017-07-11
Last updated
2017-07-11

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03212573. Inclusion in this directory is not an endorsement.