Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Università Vita-Salute San Raffaele

Status: Completed

Conditions: Pancreatic Neoplasms

Treatments: Drug: Epidural analgesia with naropin + sufentanil; Drug: Pre-anesthetic medication with diazepam; Procedure: Standard perioperative care; Drug: PONV prophylaxis with Ondansetron + Dexamethasone; Behavioral: Preadmission counselling; Behavioral: Enhanced recovery after surgery protocol; Other: Postoperative mobilization program; Drug: Preoperative bowel preparation with sodium phosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT01759706

ERAS_PANCREAS 01

Details and patient eligibility

About

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).

Full description

A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.

Enrollment: 123 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing elective pancreaticoduodenectomy

Exclusion criteria

• Intraoperative detection of metastatic disease (non-operability)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Enhanced Recovery After Surgery (ERAS)

Experimental group

Description:

Patients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.

Treatment:

Drug: PONV prophylaxis with Ondansetron + Dexamethasone

Behavioral: Preadmission counselling

Behavioral: Enhanced recovery after surgery protocol

Drug: Epidural analgesia with naropin + sufentanil

Other: Postoperative mobilization program

Standard perioperative care (Control)

Active Comparator group

Description:

Patients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4

Treatment:

Drug: Preoperative bowel preparation with sodium phosphate

Drug: Pre-anesthetic medication with diazepam

Procedure: Standard perioperative care

Drug: Epidural analgesia with naropin + sufentanil