Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
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

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer 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®) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1.

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
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