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

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain

Treatments: Combination Product: Standard care; Combination Product: ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03212573

HRJC17/18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

ERAS protocol

Experimental group

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)

Treatment:

Combination Product: ERAS protocol

Standard care

Active Comparator group

Description:

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

Treatment:

Combination Product: Standard care