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Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Enhanced recovery after surgery protocol
Standard perioperative care
PONV prophylaxis with Ondansetron + Dexamethasone
Postoperative mobilization program
Epidural analgesia with naropin + sufentanil
Pre-anesthetic medication with diazepam
Preadmission counselling
Preoperative bowel preparation with sodium phosphate
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

  • Intraoperative detection of metastatic disease (non-operability)

Sites / Locations

  • San Raffaele Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Recovery After Surgery (ERAS)

Standard perioperative care (Control)

Arm 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.

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

Outcomes

Primary Outcome Measures

Adherence to the pathway
Adherence to single items of the pathway.

Secondary Outcome Measures

Postoperative outcome
Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.

Full Information

First Posted
December 21, 2012
Last Updated
December 3, 2014
Sponsor
Università Vita-Salute San Raffaele
Collaborators
Ospedale San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01759706
Brief Title
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
Official Title
Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele
Collaborators
Ospedale San Raffaele

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Recovery After Surgery (ERAS)
Arm Type
Experimental
Arm 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.
Arm Title
Standard perioperative care (Control)
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Enhanced recovery after surgery protocol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard perioperative care
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PONV prophylaxis with Ondansetron + Dexamethasone
Other Intervention Name(s)
Zofran + Decadron
Intervention Description
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
Intervention Type
Other
Intervention Name(s)
Postoperative mobilization program
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Epidural analgesia with naropin + sufentanil
Other Intervention Name(s)
Disufen
Intervention Description
Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Intervention Type
Drug
Intervention Name(s)
Pre-anesthetic medication with diazepam
Other Intervention Name(s)
Valium
Intervention Description
Premedication before general anesthesia
Intervention Type
Behavioral
Intervention Name(s)
Preadmission counselling
Intervention Description
Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
Intervention Type
Drug
Intervention Name(s)
Preoperative bowel preparation with sodium phosphate
Other Intervention Name(s)
Phospho-Lax
Intervention Description
Preoperative bowel preparation with oral assumption of sodium phosphate
Primary Outcome Measure Information:
Title
Adherence to the pathway
Description
Adherence to single items of the pathway.
Time Frame
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 Measure Information:
Title
Postoperative outcome
Description
Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.
Time Frame
The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing elective pancreaticoduodenectomy Exclusion Criteria: Intraoperative detection of metastatic disease (non-operability)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Braga, MD
Organizational Affiliation
Università Vita-Salute San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Hospital
City
Milan
State/Province
MI
ZIP/Postal Code
20129
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18844251
Citation
Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
Results Reference
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PubMed Identifier
22956014
Citation
Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.
Results Reference
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Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

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