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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Feb 3, 2023

Keywords

ClinConnect Summary

The INCyst Trial is a clinical study aimed at understanding how a special type of nutrition, known as immunonutrition, given before surgery can affect recovery in patients undergoing a cystectomy, which is a surgical procedure to remove the bladder. The main goal is to see if taking this nutrition can help reduce complications after surgery and improve the body's immune response. Additionally, the study will try to find out which patients might benefit the most from this type of nutrition.

To be eligible for this trial, participants need to be at least 18 years old and scheduled for an open cystectomy for any reason. They should be able to give their consent to participate. However, certain individuals may not qualify, such as those with allergies to ingredients used in immunonutrition or those currently on medications that suppress the immune system. If you join the study, you will receive either the immunonutrition or standard care, and your progress will be monitored during the recovery period. This trial is currently looking for participants across three centers in Switzerland, and it’s an important opportunity to contribute to research that could improve outcomes for future patients facing similar surgeries.

Gender

ALL

Eligibility 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)