NCT01759706

Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2013-01-03
• Last updated: 2014-12-05

Locations

1 site across 1 country: Italy