Randomized clinical trial of an enhanced recovery after surgery protocol in patients undergoing pancreaticoduodenectomy
Not Applicable
- Conditions
- Patients to require pancreaticoduodenectomy
- Registration Number
- JPRN-UMIN000014068
- Lead Sponsor
- Okayama University Graduate School of Medicine and Dentistry, Department of Gastroenterological Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
(1)failure to obtain consent (2)severe respiratory dysfunction (arterial PaO2 < 70 mmHg) (3)severe cardiac dysfunction (NYHA > 2) (4)severe hepatic dysfunction (Child Pugh class C) (5)severe renal dysfunction (hemodialysis) (6)pregnancy (7)preoperative chemotherapy and/or radiation therapy (8)acute bacterial or viral infections (9)severe psychiatric disorder (10)immunocompromised status (11)advanced malignancy (12)palliative surgery (13)emergency surgery (14)investigator not available
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method median length of postoperative hospital stay
- Secondary Outcome Measures
Name Time Method (1)postoperative morbidity/mortality (2)immune and metabolism response (3)Compliance with components of the enhanced recovery after surgery (ERAS) protocol (4)mean medical cost (5)Safety