Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstructio
- Conditions
- head and neck cancer surgery patients with free flaps reconstruction
- Registration Number
- JPRN-UMIN000013158
- Lead Sponsor
- Tokyo Medical University Hachioji Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1.Pregnancy or lactation 2.Less than 20 years of age 3.Very short vital prognosis (expected to live less than 28 days due to uncontrolled cancer or other chronic or incurable terminal diseases) 4.Recent stroke or subarachnoid hemorrhage 5.Non-functioning ileus or intestinal tract 6.Significant immunosuppression (leukocytes<1000 cells/mm3) 7.Infection with human immunodeficiency virus 8.Hyperlipidemia (TG>500, T-cho>300) 9.Unsuitability for enteral nutrition 10.Recent gastrointestinal hemorrhage 11.Poorly controlled diarrhea 12.Congenital metabolism disorder 13.Milk protein intolerance 14.Acute nephritis, nephrosis, end-stage renal disease requiring strict limitation of protein, electrolytes 15.Cardiac failure accompanied by nausea, vomiting, diarrhea 16.Participation in another trial within 30 days prior to registration for present trial 17.Judged unsuitable by principal or sub-investigator for other reasons
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method