Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
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ClinicalTrials.gov Identifier: NCT01759706 |
Recruitment Status
:
Completed
First Posted
: January 3, 2013
Last Update Posted
: December 5, 2014
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Condition or disease | Intervention/treatment | Phase |
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 123 participants |
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. |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | January 2013 |
Arm | Intervention/treatment |
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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.
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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.
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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
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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
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All patients undergoing elective pancreaticoduodenectomy
Exclusion Criteria:
- Intraoperative detection of metastatic disease (non-operability)

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
Italy | |
San Raffaele Hospital | |
Milan, MI, Italy, 20129 |
Principal Investigator: | Marco Braga, MD | Università Vita-Salute San Raffaele |
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 Posted: | January 3, 2013 Key Record Dates |
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 Sufentanil Ropivacaine BB 1101 |
Anesthetics 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 |