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Pancreatic Neoplasms | Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Pancreatic Neoplasms research study

What is the primary objective of this study?

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).

Who is eligible to participate?

Inclusion Criteria: - All patients undergoing elective pancreaticoduodenectomy Exclusion Criteria: - Intraoperative detection of metastatic disease (non-operability)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pancreatic Neoplasms

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Enhanced recovery after surgery protocolERAS 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.

Procedure:Standard perioperative careEpidural 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:PONV prophylaxis with Ondansetron + DexamethasonePostoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.

Other:Postoperative mobilization programPatient 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 + sufentanilMidthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL

Drug:Pre-anesthetic medication with diazepamPremedication before general anesthesia

Behavioral:Preadmission counsellingPatient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.

Drug:Preoperative bowel preparation with sodium phosphatePreoperative bowel preparation with oral assumption of sodium phosphate

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

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

Study Status

Completed

Start Date: October 2010

Completed Date: January 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Adherence to the pathway

Secondary Outcome: Postoperative outcome

Study sponsors, principal investigator, and references

Principal Investigator: Marco Braga, MD

Lead Sponsor: Università Vita-Salute San Raffaele

Collaborator: Ospedale San Raffaele

More information:https://clinicaltrials.gov/show/NCT01759706

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.

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