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| Name | Class |
|---|---|
| Ospedale San Raffaele | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Experimental | Patients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter. |
|
| Standard perioperative care (Control) | Active Comparator | Patients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Braga, MD | Università Vita-Salute San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | MI | 20129 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18844251 | Background | 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. | |
| 22956014 | Background | Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer 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(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available. |
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|
| 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. |
|
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| 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 |
|
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| Pre-anesthetic medication with diazepam | Drug | Premedication before general anesthesia |
|
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| 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 |
|
|
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D015360 | Analgesia, Epidural |
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| D003975 | Diazepam |
| C018279 | sodium phosphate |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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