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
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 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 sodium phosphate Sodium phosphate Sodium polystyrene sulfonate Sodium phosphate, dibasic Dexamethasone acetate Sufentanil citrate Ropivacaine monohydrochloride Ondansetron hydrochloride Ondansetron

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

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.


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

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 (Adult, Senior)
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

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:

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
Study First Received:	December 21, 2012
Last Updated:	December 3, 2014
Health Authority:	Italy: Ministry of Health

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 Dexamethasone 21-phosphate 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

ClinicalTrials.gov processed this record on September 23, 2016