RecruitingBladder CancerInterstitial CystitisPainful Bladder Syndrome
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Centre Hospitalier Universitaire Vaudois
You may qualify if…
- ✓ Patient undergoing open cystectomy (for all reasons)
- ✓ Age ≥18 years
- ✓ Ability and willingness to provide informed consent documented by signature
You may not qualify if…
- ✕ 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
Source: ClinicalTrials.gov · NCT05726786 · last updated 2025-12-09