ERAS Program Implementation for MIPD

Seoul National University

Status: Not yet enrolling

Conditions: ERAS; Minimally Invasive Surgery; Pancreaticoduodenectomy

Treatments: Procedure: ERAS; Procedure: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT07017361

H-2502-154-1619

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Conventional

Active Comparator group

Treatment:

Procedure: Conventional

ERAS

Experimental group

Treatment:

Procedure: ERAS