About this trial
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.
Eligibility criteria
Qualifiers
Patient undergoing open cystectomy (for all reasons)
Age ≥18 years
Ability and willingness to provide informed consent documented by signature
Disqualifiers
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
Trial design
Treatments tested in this trial
- Immunonutrition
Treatment groups
Sponsors and collaborators
Centre Hospitalier Universitaire Vaudois
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborator
Hôpital Riviera-Chablais, Vaud-Valais
Collaborator
University Hospital, Geneva
Collaborator