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Effect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety – UroCCR 113)

dc.rights.licenseopenen_US
hal.structure.identifierBoRdeaux Institute in onCology [Inserm U1312 - BRIC]
dc.contributor.authorPITOUT, Alice
hal.structure.identifierBoRdeaux Institute in onCology [Inserm U1312 - BRIC]
dc.contributor.authorMARGUE, Gaelle
dc.contributor.authorSARRAZIN, Joffrey
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorLARRIBERE, Hugo
hal.structure.identifierCultures et Diffusion des Savoirs [CeDS]
dc.contributor.authorMASANET, Sarah
dc.contributor.authorWAECKEL, Thibaut
dc.contributor.authorBIGOT, Pierre
dc.contributor.authorBOISSIER, Romain
dc.contributor.authorPARIER, Bastien
dc.contributor.authorDE VERGIE, Stephane
hal.structure.identifierBoRdeaux Institute in onCology [Inserm U1312 - BRIC]
dc.contributor.authorJAFFREDO, Manon
hal.structure.identifierBoRdeaux Institute in onCology [Inserm U1312 - BRIC]
dc.contributor.authorRICARD, Solene
dc.contributor.authorHOARAU, Helene
hal.structure.identifierCultures et Diffusion des Savoirs [CeDS]
dc.contributor.authorJUTAND, Marthe-Aline
dc.contributor.authorFAESSEL, Matthieu
dc.contributor.authorSABATIER, Jocelyn
hal.structure.identifierBoRdeaux Institute in onCology [Inserm U1312 - BRIC]
dc.contributor.authorBERNHARD, Jean-Christophe
dc.date.accessioned2025-07-08T12:30:52Z
dc.date.available2025-07-08T12:30:52Z
dc.date.issued2025-04-04
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/207269
dc.description.abstractEnBackground The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery has proved its worth as a surgical aid but it could also help patients to manage their own care, by reducing their anxiety and increasing their understanding of the disease and its treatment. We aim to test this hypothesis with a prospective multicenter trial. Methods R3DP-A (Rein 3D – Anxiety) is an unblinded, multicenter, randomized, prospective, superiority-controlled trial. Participants are patients with kidney tumors treated by robot-assisted partial laparoscopic nephrectomy. The 234 patients (78x3 groups) from 6 French centers will undergo a pre-operative consultation dedicated to a personalized explanation of the surgical management and its risks. They will be randomized into three (1:1:1) groups corresponding to three types of support for consultation: use of a virtual 3D model of the kidney and its tumor; a printed 3D model; or the standard information sheet from the French Association of Urology (control group). Several self-questionnaires will be sent by the UroConnect® application and completed at different times during the study. The primary endpoint will be pre-operative anxiety (STAI-state questionnaire completed the day before surgery D-1). Secondary endpoints will be changes in anxiety levels between the pre-operative and post-operative consultations (between inclusion and D15 post-op), changes in health literacy and quality of life (HLSEU-Q16 and EQ-5D-5L questionnaires at inclusion and D15), feelings of understanding of the disease and its treatment at pre-operative period (Wake questionnaire at D-1), and consultation times. Discussion We aim to highlight a benefit of using a personalized 3D model on the anxiety level of patients undergoing partial nephrectomy surgery, as well as on their level of understanding of their pathology and its surgical treatment. The use of these models could be incorporated into current practice to improve patient experience throughout care. © 2025 Pitout et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
dc.description.sponsorshipEnhanced surgical kidney cancer care through digital and 3D technologiesen_US
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enEffect on preoperative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor: study protocol for a randomized controlled trial (Rein 3D Print-Anxiety – UroCCR 113)
dc.title.alternativePLoS Oneen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1371/journal.pone.0321747en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40273160en_US
bordeaux.journalPLoS ONEen_US
bordeaux.pagee0321747en_US
bordeaux.volume20en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue4en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.institutionSciences Po Bordeaux
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
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hal.popularnonen_US
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dc.rights.ccPas de Licence CCen_US
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