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Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

Information source: Università Vita-Salute San Raffaele
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pancreatic Neoplasms

Intervention: Enhanced recovery after surgery protocol (Behavioral); Standard perioperative care (Procedure); PONV prophylaxis with Ondansetron + Dexamethasone (Drug); Postoperative mobilization program (Other); Epidural analgesia with naropin + sufentanil (Drug); Pre-anesthetic medication with diazepam (Drug); Preadmission counselling (Behavioral); Preoperative bowel preparation with sodium phosphate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Università Vita-Salute San Raffaele

Official(s) and/or principal investigator(s):
Marco Braga, MD, Principal Investigator, Affiliation: Università Vita-Salute San Raffaele

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).

Clinical Details

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

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

Primary outcome: Adherence to the pathway

Secondary outcome: Postoperative outcome

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients undergoing elective pancreaticoduodenectomy

Exclusion Criteria:

- Intraoperative detection of metastatic disease (non-operability)

Locations and Contacts

San Raffaele Hospital, Milan, MI 20129, Italy
Additional Information

Related 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.

Starting date: October 2010
Last updated: December 3, 2014

Page last updated: August 23, 2015

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