Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
| Korea University Anam Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator |
| |
| ERAS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon | Up to the afternoon of Post-operative Day 5 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Jae Cho, M.D. | Contact | +821023783631 | whdudwo85@naver.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Daehak-ro, Jongno-gu | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2025 | Jun 3, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ERAS | Procedure | 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. |
|
| Total Direct Medical Costs per Participant (KRW) During Index Hospitalization | Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30) |