Actively Recruiting
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2025-12-09
232
Participants Needed
4
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire Vaudois
Lead Sponsor
I
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient undergoing open cystectomy (for all reasons)
- Age 6518 years
- Ability and willingness to provide informed consent documented by signature
You will not qualify if you...
- Known hypersensitivity or allergy to lactose, fish oil, or soy lecithin
- Severe diarrhoea requiring medical attention
- Current treatment with any immunosuppressive drug
- Pregnant or lactating women
- Clinically significant diseases affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient)
- Inability to follow study procedures due to psychological disorders or dementia
- Participation in another study with investigational drug within 30 days before or during this study
- Previous enrolment in this study
- Use of immunonutrition independently of this study
- Investigator, family members, employees, or dependents enrolled
- Emergency procedure with less than 7 days between screening and surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Centre Hospitalier Universitaire Vaudois, CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
2
University Hospital of Bern
Bern, Switzerland
Actively Recruiting
3
University Hospital of Geneva
Geneva, Switzerland
Actively Recruiting
4
Hospital of Riviera-Chablais
Rennaz, Switzerland
Actively Recruiting
Research Team
I
Ilaria Lucca, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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