The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) (INCyst)
Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome
About this trial
This is an interventional supportive care trial for Bladder Cancer focused on measuring Cystectomy, Immunonutrition, Complication, Malnutrition
Eligibility Criteria
Inclusion Criteria: Patient undergoing open cystectomy (for all reasons) Age ≥18 years Ability and willingness to provide informed consent documented by signature Exclusion Criteria: Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin Severe diarrhoea requiring medical attention Current treatment with any immunosuppressive drug In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...) Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc. Participation in another study with investigational drug within the 30 days preceding and during the present study Previous enrolment into the current study Use of IN independently of the study Enrolment of the investigator, his/her family members, employees and other dependent persons Emergency procedure (less than 7 days between screening and surgery)
Sites / Locations
- Centre Hospitalier Universitaire Vaudois, CHUVRecruiting
- University Hospital of Bern
- Hospital of Riviera-Chablais
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Immunonutrition
No immunonutrition (control)
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
Standard of care