Impact of preoperative immunonutrition on recovery after bladder surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of preoperative oral immunonutrition on postoperative complications in patients undergoing cystectomy for bladder-related conditions. It is a multicentric, prospective, controlled study that aims to determine whether immunonutrition can reduce morbidity and improve immune response after surgery. The study will also seek to identify which patients are most likely to benefit from this nutritional intervention. By comparing outcomes across different centers, the trial aims to provide robust evidence on the efficacy of immunonutrition in this surgical context.

Why it matters

Who can join: the full rules

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's running

• Centre Hospitalier Universitaire Vaudois, CHUV
  Lausanne, Canton of Vaud, Switzerland Recruiting
• University Hospital of Bern
  Bern, Switzerland Recruiting
• University Hospital of Geneva
  Geneva, Switzerland Recruiting
• Hospital of Riviera-Chablais
  Rennaz, Switzerland Recruiting

Study contacts

• Study coordinator: Ilaria Lucca, MD
• Email: ilaria.lucca@chuv.ch
• Phone: +41213142980

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.