Impact of preoperative immunonutrition on recovery after bladder surgery
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
This study tests if special nutritional drinks before bladder surgery can help patients recover better and have fewer complications afterward.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 4 sites (Lausanne, Canton of Vaud and 3 other locations) |
| Trial ID | NCT05726786 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for open cystectomy.
Not a fit: Patients with contraindications to immunonutrition or those with severe concurrent diseases affecting immunity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for patients undergoing cystectomy.
How similar studies have performed: Previous studies have shown that preoperative immunonutrition can reduce complications in major surgeries, but specific evidence for cystectomy patients is limited, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lausanne, Canton of Vaud and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.