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

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.

Eligibility

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)

Conditions8

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