Clinical trial · Interventional
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Disease | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Hemorrhagic Cystitis | — | UNRESOLVED | — |
| Interstitial Cystitis | — | UNRESOLVED | — |
| Neurogenic Bladder | — | UNRESOLVED | — |
| Painful Bladder Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunonutrition | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunonutrition
- description
- Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
- interventionNames
- Drug: Immunonutrition
- type
- NO_INTERVENTION
- label
- No immunonutrition (control)
- description
- Standard of care
Primary outcomes (1)
- measure
- Infectious complication after cystectomy
- timeFrame
- 30-days afetr surgery
- description
- Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDDerre L, Crettenand F, Grilo N, Stritt K, Kiss B, Tawadros T, Domingos-Pereira S, Roth B, Cerantola Y, Lucca I. The role of preoperative immunonutrition on morbidity and immune response after cystectomy: protocol of a multicenter randomized controlled trial (INCyst Trial). Trials. 2024 Oct 17;25(1):687. doi: 10.1186/s13063-024-08536-5. PMID 39415282