The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: Hôpital Riviera-Chablais, Vaud-Valais; University Hospital Inselspital, Berne

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)