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Completed

NCT Number: NCT01759706

Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy

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).

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Key information

Conditions

Pancreatic Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, MI, 20129, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing elective pancreaticoduodenectomy

Exclusion criteria

  • Intraoperative detection of metastatic disease (non-operability)

Treatment and study plan

Enhanced recovery after surgery protocol

Behavioral

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.

Standard perioperative care

Procedure

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

PONV prophylaxis with Ondansetron + Dexamethasone

Drug

Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.

Other names: Zofran + Decadron

Postoperative mobilization program

Other

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

Epidural analgesia with naropin + sufentanil

Drug

Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL

Other names: Disufen

Pre-anesthetic medication with diazepam

Drug

Premedication before general anesthesia

Other names: Valium

Preadmission counselling

Behavioral

Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.

Preoperative bowel preparation with sodium phosphate

Drug

Preoperative bowel preparation with oral assumption of sodium phosphate

Other names: Phospho-Lax

Primary outcomes

  1. Adherence to the pathway

    Time frame: 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.

    Adherence to single items of the pathway.

Secondary outcomes

  1. Postoperative outcome

    Time frame: The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge

    Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

  • Ospedale San Raffaele

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jan 3, 2013
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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