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Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Università Vita-Salute San Raffaele
Sponsor:
Collaborator:
Ospedale San Raffaele
Information provided by (Responsible Party):
Marco Braga, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01759706
First received: December 21, 2012
Last updated: January 2, 2013
Last verified: December 2012
  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
Pancreaticoduodenectomy (E04.210.760)
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.

Resource links provided by NLM:


Further study details as provided by 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.


Estimated Enrollment: 150
Study Start Date: October 2010
Primary Completion Date: October 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

  • Intraoperative detection of metastatic disease (non-operability)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759706

Contacts
Contact: Marco Braga, MD +390226432146 braga.marco@hsr.it
Contact: Nicolo' Pecorelli, MD +390226432639 pecorelli.nicolo@hsr.it

Locations
Italy
San Raffaele Hospital Recruiting
Milan, MI, Italy, 20129
Contact: Marco Braga, MD       braga.marco@hsr.it   
Principal Investigator: Marco Braga, MD         
Sub-Investigator: Nicolo' Pecorelli, MD         
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
Study First Received: December 21, 2012
Last Updated: January 2, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Anesthetics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Diazepam
Ondansetron
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anti-Inflammatory Agents
Anticonvulsants
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Enzyme Inhibitors
GABA Agents
GABA Modulators
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2014