The role of preoperative immunonutrition on morbidity and immune response after cystectomy: protocol of a multicenter randomized controlled trial (INCyst Trial).
Humans
Cystectomy
/ adverse effects
Preoperative Care
/ methods
Postoperative Complications
/ prevention & control
Gastrointestinal Microbiome
Multicenter Studies as Topic
Nutritional Status
Pragmatic Clinical Trials as Topic
Treatment Outcome
Urinary Bladder Neoplasms
/ surgery
Switzerland
Time Factors
Malnutrition
/ immunology
Immunonutrition Diet
Bladder cancer
Complications
Cystectomy
Immune cells
Immunonutrition
Infection
Microbiota
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 Oct 2024
17 Oct 2024
Historique:
received:
20
03
2024
accepted:
07
10
2024
medline:
17
10
2024
pubmed:
17
10
2024
entrez:
16
10
2024
Statut:
epublish
Résumé
Cancer, malnutrition, and surgery negatively impact patient's immune system. Despite standardized surgical technique and the development of new perioperative care protocols, morbidity after cystectomy remains a serious challenge for urologists. Most common postoperative complications, such as infections and ileus, often lead to longer length of stay and worse survival. The immune system and its interaction with the gut microbiota play a pivotal role in cancer immunosurveillance and in patient's response to surgical stress. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. Immunonutrition (IN) may improve the nutritional status, immunological function, and clinical outcome of surgical patients. Aims of the study are (1) to evaluate the impact of IN on morbidity and mortality at 30 and 90 days after cystectomy and (2) to determine immune and microbiota signature that would predict IN effect. This is a randomized, multicentric, controlled, pragmatic, parallel-group comparative study, supported by the Swiss National Science Foundation. A total of 232 patients is planned to be enrolled between April 2023 and June 2026. Three participating centers (Lausanne, Bern, and Riviera-Chablais) have been selected. All patients undergoing elective radical and simple cystectomy will be randomly assigned to receive 7 days of preoperative IN (Oral Impact Strengths of the INCyst study include the randomized, multicenter, prospective design, the large number of patients studied, and the translational investigation. This study will challenge the added value of preoperative IN in patients undergoing cystectomy, assessing the clinical effect of IN on the onset of postoperative morbidity and mortality after cystectomy. Furthermore, it will provide invaluable data on the host immune response and microbiota composition. ClinicalTrials.gov NCT05726786. Registered on March 9, 2023.
Identifiants
pubmed: 39415282
doi: 10.1186/s13063-024-08536-5
pii: 10.1186/s13063-024-08536-5
doi:
Banques de données
ClinicalTrials.gov
['NCT05726786']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
687Informations de copyright
© 2024. The Author(s).
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