NCT05726786Recrutement en cours
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Résumé
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.
Critères d'inclusion
• Patient undergoing open cystectomy (for all reasons) • Age ≥18 years • Ability and willingness to provide informed consent documented by signature
Critères d'exclusion
• 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)
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- Centre Hospitalier Universitaire Vaudois(Autre)
- N° de protocole
- INCyst
- Pathologies
- Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis, Bladder Disease
- Interventions
- Médicament
Traitements évalués
- Immunonutrition
Collaborateurs
Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais, University Hospital, Geneva
Lieux · 4
- Lausanne, SuisseCentre Hospitalier Universitaire Vaudois, CHUVRecrute dans ce centre
- Bern, SuisseUniversity Hospital of BernRecrute dans ce centre
- Geneva, SuisseUniversity Hospital of GenevaRecrute dans ce centre
- Rennaz, SuisseHospital of Riviera-ChablaisRecrute dans ce centre
Au total, dans le monde, les 4 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 9 décembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.