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NOT YET RECRUITING
NCT07017361
NA

ERAS Program Implementation for MIPD

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-07-15

Completion Date

2027-12-31

Last Updated

2025-06-17

Healthy Volunteers

No

Interventions

PROCEDURE

Conventional

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.

PROCEDURE

ERAS

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.

Locations (1)

Seoul National University Hospital

Daehak-ro, Jongno-gu, Seoul, South Korea