None listed
Conditions
Interventions
Others(Enhanced Recovery After Surgery (ERAS) perioperative management) : Enhanced Recovery After Surgery (ERAS) perioperative protocol for pancreaticoduodenectomy
Target population/timeline: Patients
perioperative management from pre-admission to postoperative day (POD) 5.
1) Preoperative management
(1) Fasting/Carbohydrate loading
• ERAS group: Solid diet restricted after midnight
water allowed until 3 hours before surgery
1 can of carbohydrate drink administered orally (PO) 2–4 hours before surgery.
• Control group: Nil per os (NPO) after midnight, including water
no carbohydrate drink provided.
(2) Preemptive analgesia
• ERAS group: Acetaminophen 650 mg (1 tablet) + Zaltoprofen 80 mg (1 tablet) administered orally (PO) 2–4 hours before surgery.
• Control group
approximately 1 hour before the end of surgery, Acetaminophen 1 g IV + Ibuprofen 300 mg IV + Nefopam 20 mg IV administered.
• Control group: Dexamethasone 5 mg IV at induction
approximately 1 hour before the end of surgery, Acetaminophen 1 g IV only.
3) Postoperative diet
• Common starting point: Small amount of water or soft fluid diet (SOW) from the morning of POD1.
• Pr
if POD4 percutaneous biliary-pancreatic (PBP) CT shows no abnormality, start soft bland diet (SBD) from POD4 lunch.
o ERAS group: If abdominal erect X-ray on POD2 morning shows no abnormality, start S
if POD3 PBP CT shows
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for enrollment: - Patients aged =70 years who have undergone pancreaticoduodenectomy for periampullary neoplasms. - Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of enrollment. - Ability to provide written informed consent, understand the trial procedures, and appropriately complete patient-reported questionnaires. - Patients classified as American Society of Anesthesiologists (ASA) physical status class I–III.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the trial: - Known hypersensitivity or allergic reaction to fentanyl or ropivacaine used for pain management. - Requirement for concomitant surgery involving other organs. - Cognitive impairment that prevents the patient from properly using a patient-controlled analgesia (PCA) device or completing questionnaires (i.e., inability to follow general medical instructions). A history of simple dementia diagnosis or treatment alone is not considered exclusionary. - Presence of major comorbid conditions that may influence treatment outcomes, including: diagnosis or treatment of another malignancy within the past 3 years, history of heart failure or coronary artery disease within the past 1 year, history of organ transplantation, or uncontrolled medical illness at the time of surgery. - Severe hepatic or renal disease. - Any condition deemed inappropriate for participation in this clinical trial by the investigator or study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients meeting all discharge criteria on postoperative day 5 (Discharge criteria: Tolerance of soft blended diet for 24h, Safe ambulation without assistance, Adequate pain control (NRS =3) with only oral non-opioid analgesics, Afebrile status of <37.2? without major complications, No clinically concerning lab findings (WBC, CRP)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance rate for ERAS protocol;length of hospital stay;Incidence rate of clinically relevant Postoperative pancreatic fistula (POPF);Postoperative mortality;Postoperative pain score (NRS score);Readmission within 30 days after discharge | — |
Countries
Korea, Republic of
Contacts
Public ContactHye-Sol Jung
Seoul National University Hospital
Outcome results
None listed