Evidence map›Paper›PMID 39415282›Full record

ArticleTrials2024

The role of preoperative immunonutrition on morbidity and immune response after cystectomy: protocol of a multicenter randomized controlled trial (INCyst Trial).

Laurent Derré, François Crettenand, Nuno Grilo, Kevin Stritt, Bernhard Kiss, Thomas Tawadros, Sonia Domingos-Pereira, Beat Roth, Yannick Cerantola, Ilaria Lucca

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05726786 (The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05726786 phase3recruitingnot on this map

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)

TypeinterventionalSponsorCentre Hospitalier Universitaire VaudoisRan2023 to 2026Enrolled232ConditionsBladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic BladderArmsImmunonutrition
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Laurent DerréDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
François CrettenandDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Nuno GriloDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Kevin StrittDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Bernhard KissDepartment of Urology, University Hospital of Bern, University of Bern, Bern, Switzerland.
Thomas TawadrosDepartment of Urology, Hospital of Riviera-Chablais, Rennaz, Switzerland.
Sonia Domingos-PereiraDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Beat RothDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Yannick CerantolaDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.
Ilaria LuccaDepartment of Urology, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland. ilaria.lucca@chuv.ch.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCancer, 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.

methodsThis 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 DISCUSSION AND

conclusionStrengths 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.

trial registrationClinicalTrials.gov NCT05726786. Registered on March 9, 2023.

Indexed as

CystectomyGastrointestinal MicrobiomeMulticenter Studies as TopicPostoperative ComplicationsPreoperative CareHumansImmunonutrition DietMalnutritionNutritional StatusPragmatic Clinical Trials as TopicSwitzerlandTime FactorsTreatment OutcomeUrinary Bladder NeoplasmsBladder cancerComplicationsCystectomyImmune cellsImmunonutritionInfectionMicrobiota

Identifiers

PMID39415282
PMCPMC11483975

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.