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

RecruitingPhase 3Ages 18 Years - anyAllCentre Hospitalier Universitaire Vaudois
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patient undergoing open cystectomy (for all reasons) * Age โ‰ฅ18 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)
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What it tests

  • Immunonutrition
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Where

4 sites
Centre Hospitalier Universitaire Vaudois, CHUV
Lausanne, Switzerland
University Hospital of Bern
Bern, Switzerland
University Hospital of Geneva
Geneva, Switzerland
Hospital of Riviera-Chablais
Rennaz, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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