The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy.
As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.
This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.
Patient undergoing open cystectomy (for all reasons)
Age ≥18 years
Ability and willingness to provide informed consent documented by signature
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
Parallel
Immunonutrition
DrugImmunonutrition: Oral Impact®, Nestlé Health Science, Switzerland. IN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact® is a powdered oral feed that provides 309 kcal/bag
Infectious complication after cystectomy
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
Comprehensive Complication Index (CCI)
Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).
Mortality rate
Determination of the mortality rate at 30 and 90 days after surgery
Complication-free survival rate
Determination of the post-operative complication-free survival
Treatment compliance rate
Serum arginine levels will be assessed at enrolment (between Day -30 and Day -10) and at preoperative admission after intake of the allocated nutrition (Day -1) in all patients treated at Lausanne, CHUV.
Cancer-specific survival rate
Long term overall and cancer-specific survival for bladder cancer patients
Quality of life assessment
Assessment of the quality of life after surgery through a questionnaire (EORTC QLQ-C30)
Identification of biomarkers predictive of postoperative complications
Identification of biomarkers predictive of postoperative complications studying the patient's immune and microbiome signature: analysis of immune cells in the blood, analysis of the polyfunctionality of blood T cells, analysis of immune-related proteins in the urine and serum, microbiota analysis, expression of Argininosuccinate synthetase 1
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Centre Hospitalier Universitaire Vaudois
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
Hôpital Riviera-Chablais, Vaud-Valais
Collaborator
University Hospital, Geneva
Collaborator
