Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Not Applicable

Completed

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

• Registration Number: NCT01759706
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-12
• Study First Submitted: 2012-12-21
• Study Completion: 2013-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria

• Intraoperative detection of metastatic disease (non-operability)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard perioperative care (Control)	Pre-anesthetic medication with diazepam	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
Enhanced Recovery After Surgery (ERAS)	Enhanced recovery after surgery protocol	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.
Enhanced Recovery After Surgery (ERAS)	Epidural analgesia with naropin + sufentanil	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.
Enhanced Recovery After Surgery (ERAS)	Preadmission counselling	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.
Standard perioperative care (Control)	Preoperative bowel preparation with sodium phosphate	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
Enhanced Recovery After Surgery (ERAS)	PONV prophylaxis with Ondansetron + Dexamethasone	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.
Standard perioperative care (Control)	Epidural analgesia with naropin + sufentanil	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
Enhanced Recovery After Surgery (ERAS)	Postoperative mobilization program	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.
Standard perioperative care (Control)	Standard perioperative care	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

Primary Outcome Measures

Name	Time	Method
Adherence to the pathway	Participants will be followed from two weeks before surgery, for the duration of hospital stay, and for 30 days after discharge, an expected average of 8 weeks.	Adherence to single items of the pathway.

Secondary Outcome Measures

Name	Time	Method
Postoperative outcome	The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge	Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, MI, Italy