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
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