Pancreatic Neoplasms
Conditions
Brief 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).
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.
Interventions
BEHAVIORALEnhanced 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.
PROCEDUREStandard 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
DRUGPONV prophylaxis with Ondansetron + Dexamethasone
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
OTHERPostoperative 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
DRUGEpidural analgesia with naropin + sufentanil
Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
DRUGPre-anesthetic medication with diazepam
Premedication before general anesthesia
BEHAVIORALPreadmission counselling
Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
DRUGPreoperative bowel preparation with sodium phosphate
Preoperative bowel preparation with oral assumption of sodium phosphate
Sponsors
Ospedale San Raffaele
Università Vita-Salute San Raffaele
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing elective pancreaticoduodenectomy
Exclusion criteria
* Intraoperative detection of metastatic disease (non-operability)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to 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. | Adherence to single items of the pathway. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative outcome | 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. |
Countries
Italy
Outcome results
None listed