Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy - Full Text View

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:

Drug Information available for: Dexamethasone Diazepam Dexamethasone acetate Dexamethasone sodium phosphate Sodium phosphate Sodium phosphate, dibasic Sufentanil citrate Ropivacaine monohydrochloride Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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

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

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:

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.

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. Guidelines for Perioperative Care for Pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(®)) Society Recommendations. World J Surg. 2012 Sep 7. [Epub ahead of print]

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:

Sodium phosphate
Anesthetics
Diazepam
Ropivacaine
Sufentanil
Dexamethasone acetate
Dexamethasone
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013