Preoperative immunonutrition and its role in complications and immune response after cystectomy.
Zusammenfassung der Studie
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)
Untersuchte Intervention
Cystectomy (surgical removal of the bladder)
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Bern, Genf, Lausanne, Andere
(BASEC)
HRC Rennaz
(BASEC)
Sponsor
Dr. Ilaria Lucca, University Hospital of Lausanne (CHUV)
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Ilaria Lucca
+41(0)213142981
ilaria.lucca@clutterchuv.chUniversity Hospital of Lausanne (CHUV)
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.03.2023
(BASEC)
ICTRP Studien-ID
NCT05726786 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The role of preoperative immunonutrition on morbidity and immune response after cystectomy - A multicenter randomized controlled trial (INCyst Trial) (BASEC)
Wissenschaftlicher Titel
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial) (ICTRP)
Öffentlicher Titel
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) (ICTRP)
Untersuchte Krankheit(en)
Bladder CancerInterstitial CystitisPainful Bladder SyndromeNeurogenic BladderHemorrhagic CystitisEndometriosisBladder Disease (ICTRP)
Untersuchte Intervention
Drug: Immunonutrition (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Infectious complication after cystectomy (ICTRP)
Comprehensive Complication Index (CCI);Mortality rate;Complication-free survival rate;Treatment compliance rate (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Insel Gruppe AG, University Hospital Bern;H�pital Riviera-Chablais, Vaud-Valais;University Hospital, Geneva (ICTRP)
Weitere Kontakte
Ilaria Lucca, MD, ilaria.lucca@chuv.ch, +41213142980 (ICTRP)
Sekundäre IDs
INCyst (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05726786 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar