Health TrialsbyHealthPanel

ERAS Program Implementation for MIPD

ConditionsPancreaticoduodenectomyERASMinimally Invasive Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional

    Procedure/Surgery

    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.

  • ERAS

    Procedure/Surgery

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ConventionalActive comparator 1 intervention
Group B: ERASExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon

Time frame
Up to the afternoon of Post-operative Day 5

Secondary outcomes

1

Length of Post-operative Hospital Stay (Days)

Time frame
Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)
2

Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days

Time frame
Post-operative Day 0 to Day 30
3

Total Direct Medical Costs per Participant (KRW) During Index Hospitalization

Time frame
Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Seoul National University Hospital Status unavailable 03080, Daehak-ro, Jongno-gu, SeoulSouth Korea

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

SMG-SNU Boramae Medical Center

Collaborator

Korea University Anam Hospital

Collaborator

Source ClinicalTrials.gov

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