Preoperative immunonutrition and its role in complications and immune response after cystectomy.
Descrizione riassuntiva dello studio
This is a multicenter study conducted exclusively in Switzerland. The study is open to patients who will be operated on in three Swiss hospitals (CHUV in Lausanne, Inselspital in Bern, and HRC in Rennaz). There will be two groups of participants. The first group will receive immunonutrition before the cystectomy. The second group, called the control group, will not receive it. Patient assignment will be done by randomization. The planned duration of the study is 4 years. The main objective of the study is to investigate infectious complications within 30 days after the surgical intervention.
(BASEC)
Intervento studiato
Cystectomy (surgical removal of the bladder)
(BASEC)
Malattie studiate
Our research project aims to study the benefits of immunonutrition before a cystectomy (surgical removal of the bladder), particularly its impact on postoperative complications.
(BASEC)
- Ability and willingness to provide informed consent documented by a signature. - Patient undergoing open cystectomy (for any reason) and adhering to prophylactic antibiotic treatment. - Age ≥18 years (BASEC)
Criteri di esclusione
- Contraindications to IN, such as hypersensitivity or known allergy to lactose, fish oil, or soy lecithin. - Other clinically significant comorbidities affecting immunity (e.g., severe renal failure, HIV, lupus erythematosus, transplant, etc.) - Inability to follow study procedures, for example due to language issues, psychological disorders, dementia, etc. (BASEC)
Luogo dello studio
Berna, Ginevra, Losanna, Altro
(BASEC)
HRC Rennaz
(BASEC)
Sponsor
Dr. Ilaria Lucca, University Hospital of Lausanne (CHUV)
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Ilaria Lucca
+41(0)213142981
ilaria.lucca@clutterchuv.chUniversity Hospital of Lausanne (CHUV)
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
09.03.2023
(BASEC)
ID di studio ICTRP
NCT05726786 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
The role of preoperative immunonutrition on morbidity and immune response after cystectomy - A multicenter randomized controlled trial (INCyst Trial) (BASEC)
Titolo accademico
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial) (ICTRP)
Titolo pubblico
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) (ICTRP)
Malattie studiate
Bladder CancerInterstitial CystitisPainful Bladder SyndromeNeurogenic BladderHemorrhagic CystitisEndometriosisBladder Disease (ICTRP)
Intervento studiato
Drug: Immunonutrition (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Patient undergoing open cystectomy (for all reasons)
- Age =18 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) (ICTRP)
non disponibile
Endpoint primari e secondari
Infectious complication after cystectomy (ICTRP)
Comprehensive Complication Index (CCI);Mortality rate;Complication-free survival rate;Treatment compliance rate (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Insel Gruppe AG, University Hospital Bern;H�pital Riviera-Chablais, Vaud-Valais;University Hospital, Geneva (ICTRP)
Contatti aggiuntivi
Ilaria Lucca, MD, ilaria.lucca@chuv.ch, +41213142980 (ICTRP)
ID secondari
INCyst (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05726786 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile