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Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759706
First Posted: January 3, 2013
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ospedale San Raffaele
Information provided by (Responsible Party):
Marco Braga, Università Vita-Salute San Raffaele
  Purpose
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).

Condition Intervention
Pancreatic Neoplasms 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.

Further study details as provided by Marco Braga, Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Adherence to 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. ]
    Adherence to single items of the pathway.


Secondary Outcome Measures:
  • Postoperative outcome [ Time Frame: 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.


Enrollment: 123
Study Start Date: October 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Recovery After Surgery (ERAS)
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
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.
Drug: PONV prophylaxis with Ondansetron + Dexamethasone
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
Other Name: Zofran + Decadron
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
Other Name: Disufen
Behavioral: Preadmission counselling
Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
Active Comparator: Standard perioperative care (Control)
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
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: Epidural analgesia with naropin + sufentanil
Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Other Name: Disufen
Drug: Pre-anesthetic medication with diazepam
Premedication before general anesthesia
Other Name: Valium
Drug: Preoperative bowel preparation with sodium phosphate
Preoperative bowel preparation with oral assumption of sodium phosphate
Other Name: Phospho-Lax

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

  • Intraoperative detection of metastatic disease (non-operability)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759706


Locations
Italy
San Raffaele Hospital
Milan, MI, Italy, 20129
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Ospedale San Raffaele
Investigators
Principal Investigator: Marco Braga, MD Università Vita-Salute San Raffaele
  More Information

Publications:
Responsible Party: Marco Braga, Professor in Surgery, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01759706     History of Changes
Other Study ID Numbers: ERAS_PANCREAS 01
First Submitted: December 21, 2012
First Posted: January 3, 2013
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Dexamethasone acetate
Dexamethasone
Ondansetron
Diazepam
BB 1101
Anesthetics
Sufentanil
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action