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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special nutritional drink taken before bladder removal surgery (cystectomy) can reduce complications and support the immune system's recovery. This kind of nutrition is called immunonutrition, and it contains ingredients like fish oil and amino acids. **You may be eligible if...** - You are 18 or older - You are scheduled for open cystectomy (bladder removal surgery) for any reason **You may NOT be eligible if...** - You have allergies to fish oil, soy lecithin, or lactose - You have severe malnutrition or a significant eating disorder - You have conditions that prevent oral supplementation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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