Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Pancreatic Neoplasms Clinical Trial

Official title:

Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759706
• Other study ID #: ERAS_PANCREAS 01
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: December 3, 2014
• Start date: October 2010
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

• Intraoperative detection of metastatic disease (non-operability)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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.

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:
• PONV prophylaxis with Ondansetron + Dexamethasone
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.

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
• Pre-anesthetic medication with diazepam
Premedication before general anesthesia

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

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

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan	MI

Sponsors (2)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele	Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Postoperative outcome	Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.	The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge	Yes