Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Summary

The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).

Conditions

• Pancreatic Neoplasms

Interventions

BEHAVIORAL

Enhanced recovery after surgery protocol

ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.

PROCEDURE

Standard perioperative care

Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4

DRUG

PONV prophylaxis with Ondansetron + Dexamethasone

Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.

OTHER

Postoperative mobilization program

Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward

DRUG

Epidural analgesia with naropin + sufentanil

Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL

DRUG

Pre-anesthetic medication with diazepam

Premedication before general anesthesia

BEHAVIORAL

Preadmission counselling

Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.

DRUG

Preoperative bowel preparation with sodium phosphate

Preoperative bowel preparation with oral assumption of sodium phosphate

Sponsors & Collaborators

• Ospedale San Raffaele

  collaborator OTHER

• Università Vita-Salute San Raffaele

  lead OTHER

Principal Investigators

• Marco Braga, MD · Università Vita-Salute San Raffaele

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2012-12-31

Completion

2013-01-31

Countries

• Italy

Study Locations