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

NCT05726786 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Immunonutrition

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • Hôpital Riviera-Chablais, Vaud-Valais

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2026-08-31
Completion
2026-10-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726786 on ClinicalTrials.gov