RecruitingPhase 3NCT05726786

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

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)

Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

232 participants

Start Date

Apr 10, 2023

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer Endometriosis Interstitial Cystitis Bladder Disease Painful Bladder Syndrome Neurogenic Bladder Hemorrhagic Cystitis

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

Min Age: 18 Years

Inclusion Criteria3

Patient undergoing open cystectomy (for all reasons)
Age ≥18 years
Ability and willingness to provide informed consent documented by signature

Exclusion Criteria11

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)

Interventions

DRUGImmunonutrition

Immunonutrition: Oral Impact®, Nestlé Health Science, Switzerland. IN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact® is a powdered oral feed that provides 309 kcal/bag