ERAS, Minimally Invasive Surgery, Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, ERAS, Minimally Invasive Surgery
Brief summary
To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)
Interventions
PROCEDUREConventional
Pre-operative fasting: NPO for solids and fluids from 00:00. No pre-emptive oral analgesia. Intra-operative: IV dexamethasone 5 mg at anaesthesia induction; IV acetaminophen 1 g about 1 h before wound closure. Post-operative nutrition: Levin tube removed in OR. POD1 morning-sips of water; POD3 morning upright abdominal X-ray; if normal, start soft fluid diet POD3 evening. POD4 pancreatobiliary CT; if normal, start soft bland diet at lunch. Drain management: two drains at hepaticojejunostomy and pancreaticojejunostomy; drain amylase measured POD1, 3 and 5; if POD4 CT normal, drains removable from POD5 per surgeon discretion (output, fever, pain). Analgesia: IV PCA until ≈POD3, then oral acetaminophen 650 mg every 8 h. No carbohydrate loading or NSAID/nefopam adjuncts.
PROCEDUREERAS
Pre-op fasting: solids NPO from 00:00; clear fluids until 3 h pre-op; 300 mL carbohydrate drink 2-4 h pre-op with oral acetaminophen 650 mg + zaltoprofen 80 mg. Intra-op: IV dexamethasone 8 mg at induction; IV acetaminophen 1 g + ibuprofen 300 mg + nefopam 20 mg 1 h before closure. Post-op nutrition: Levin tube removed in OR. POD1 sips of water; POD2 morning upright abdominal X-ray-if normal, start soft fluid diet POD2 evening. POD3 pancreatobiliary CT-if normal, start soft bland diet at lunch. Drain mgmt: same placement; amylase POD1 & 3; if POD4 CT normal and amylase ≤ 5 000 U/L trending down, remove drains POD4; otherwise per surgeon. Analgesia: IV PCA until ≈POD3; until POD1 morning, IV acetaminophen 1 g + ibuprofen 300 mg q8h; POD1-5, oral acetaminophen 650 mg + zaltoprofen 80 mg q8h.
Sponsors
SMG-SNU Boramae Medical Center
Korea University Anam Hospital
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors * ECOG performance status of 0 or 1 at screening * Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires * ASA physical status classification I-III
Exclusion criteria
* Hypersensitivity to fentanyl or ropivacaine * Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires * Major internal medical or psychiatric disorders affecting treatment response * Severe hepatic or renal dysfunction * Any condition deemed inappropriate for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon | Up to the afternoon of Post-operative Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Length of Post-operative Hospital Stay (Days) | Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30) |
| Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days | Post-operative Day 0 to Day 30 |
| Total Direct Medical Costs per Participant (KRW) During Index Hospitalization | Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30) |
Countries
South Korea
Contacts
Primary ContactYoung Jae Cho, M.D.
Outcome results
None listed