Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Neoplasms

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing elective pancreaticoduodenectomy Exclusion Criteria: Intraoperative detection of metastatic disease (non-operability)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Recovery After Surgery (ERAS)<br>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. | Behavioral: Enhanced recovery after surgery protocol<br>* 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.<br>Drug: PONV prophylaxis with Ondansetron + Dexamethasone<br>* Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.<br>* Other names: Zofran + Decadron;Other: Postoperative mobilization program<br>* 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<br>Drug: Epidural analgesia with naropin + sufentanil<br>* Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL<br>* Other names: Disufen;Behavioral: Preadmission counselling<br>* Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.<br>|
| Active Comparator: Standard perioperative care (Control)<br>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 | Procedure: Standard perioperative care<br>* 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<br>Drug: Epidural analgesia with naropin + sufentanil<br>* Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL<br>* Other names: Disufen;Drug: Pre-anesthetic medication with diazepam<br>* Premedication before general anesthesia<br>* Other names: Valium;Drug: Preoperative bowel preparation with sodium phosphate<br>* Preoperative bowel preparation with oral assumption of sodium phosphate<br>* Other names: Phospho-Lax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the pathway | Adherence to single items of 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative outcome | Comparison of postoperative morbidity and mortality, length of hospital stay, readmission. | The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge |