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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

Studienbeginn:
April 2023

Letztes Update:
05.09.2023

Wirkstoff:
Immunonutrition

Indikation (Clinical Trials):
Urinary Bladder, Neurogenic, Endometriosis, Cystitis, Cystitis, Interstitial, Urinary Bladder Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Centre Hospitalier Universitaire Vaudois

Collaborator:
Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais,

Kontakt

Ilaria Lucca, MD
Kontakt:
Phone: +41213142981
E-Mail: ilaria.lucca@chuv.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Centre Hospitalier Universitaire Vaudois, CHUV
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Ilaria Lucca, MD
E-Mail: ilaria.lucca@chuv.ch

François Crettenand, MD
E-Mail: francois.crettenand@chuv.ch» Ansprechpartner anzeigen

University Hospital of Bern
Bern
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Bernhard Kiss, MD
E-Mail: bernhard.kiss@insel.ch» Ansprechpartner anzeigen

Hospital of Riviera-Chablais
Rennaz
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Thomas Tawadros, PhD
E-Mail: thomas.tawadros@rivierachablais.ch» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Despite standardized surgical technique and the development of new perioperative care

protocols, cystectomy morbidity remains a serious challenge for urologists. Most common

postoperative complications, such as infections, often lead to longer length of stay and

worse survival. Malnutrition has been identified as an independent and modifiable risk factor

for both mortality and morbidity. Immunonutrition (IN), containing arginine, ribonucleic acid

and omega-3 polyunsaturated fatty acids, aims to improve the nutritional status,

immunological function and clinical outcome of surgical patients. Meta-analyses have

demonstrated that preoperative IN reduces complications and length of hospital stay after

major bowel surgery. Evidence-based data on preoperative oral IN support for cystectomy

patients are lacking, which does not allow this treatment to be widely accepted, recommended,

or reimbursed by health insurances in most European countries. Uncertainties also remain

about the exact mechanism by which IN modulates the host immune response.

Complication rates after cystectomy range from 40-75%. Malnutrition has been identified as an

independent and modifiable risk factor for both mortality and morbidity. To date, and in the

last 20 years, no single intervention has allowed for a significant reduction in morbidity

after cystectomy, which remains one of the highest in surgery. The present adequately powered

multicenter RCT has the potential of changing current practice by recommending preoperative

IN before cystectomy in case of positive results. If the present RCT demonstrates a benefit

in administrating IN prior to cystectomy, urological guidelines will be modified accordingly

to this new evidence. IN will then be recommended before cystectomy for the patient's

benefit. The investigators truly believe that the proposed study is of high clinical

importance with potential impact on perioperative urology guidelines.

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)

Studien-Rationale

Primary outcome:

1. Infectious complication after cystectomy (Time Frame - 30-days afetr surgery):
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).

Secondary outcome:

1. Comprehensive Complication Index (CCI) (Time Frame - 30 and 90 days after surgery):
Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).

2. Mortality rate (Time Frame - 30 and 90 days after surgery):
Determination of the mortality rate at 30 and 90 days after surgery

3. Complication-free survival rate (Time Frame - 90-days after surgery):
Determination of the post-operative complication-free survival

4. Treatment compliance rate (Time Frame - Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)):
Serum arginine levels will be assessed at enrolment (between Day -30 and Day -10) and at preoperative admission after intake of the allocated nutrition (Day -1) in all patients treated at Lausanne, CHUV.

Studien-Arme

Experimental: Immunonutrition
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
No Intervention: No immunonutrition (control)
Standard of care

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

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