The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Recruiting · NCT05726786 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire Vaudois
View the official record on ClinicalTrials.gov →Interventions studied
Immunonutrition
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
4 locations listed.
- University Hospital of Bern - Bern, Switzerland
- University Hospital of Geneva - Geneva, Switzerland
- Hospital of Riviera-Chablais - Rennaz, Switzerland
- Centre Hospitalier Universitaire Vaudois, CHUV - Lausanne, Canton of Vaud, Switzerland