The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCys… (NCT05726786) | Clinical Trial Compass
RecruitingPhase 3
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Switzerland232 participantsStarted 2023-04-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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)