Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
1 other identifier
interventional
123
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 21, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedDecember 5, 2014
December 1, 2014
2.2 years
December 21, 2012
December 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to the pathway
Adherence to single items of the pathway.
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.
Secondary Outcomes (1)
Postoperative outcome
The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge
Study Arms (2)
Enhanced Recovery After Surgery (ERAS)
EXPERIMENTALPatients 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.
Standard perioperative care (Control)
ACTIVE COMPARATORPatients 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
Interventions
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.
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
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
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
Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Premedication before general anesthesia
Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
Preoperative bowel preparation with oral assumption of sodium phosphate
Eligibility Criteria
You may qualify if:
- All patients undergoing elective pancreaticoduodenectomy
You may not qualify if:
- Intraoperative detection of metastatic disease (non-operability)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università Vita-Salute San Raffaelelead
- Ospedale San Raffaelecollaborator
Study Sites (1)
San Raffaele Hospital
Milan, MI, 20129, Italy
Related Publications (2)
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.
PMID: 18844251BACKGROUNDLassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer 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(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.
PMID: 22956014BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Braga, MD
Università Vita-Salute San Raffaele
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Surgery
Study Record Dates
First Submitted
December 21, 2012
First Posted
January 3, 2013
Study Start
October 1, 2010
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
December 5, 2014
Record last verified: 2014-12