Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
39 participants
INTERVENTIONAL
2024-05-28
2027-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety
NCT06035211
3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
NCT03738488
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
NCT03943771
Impact of Preemptive Living Donor Renal Transplantation on Quality of Life , Occupational Rehabilitation and Societal Participation of Transplant Recipients
NCT02893475
Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.
NCT06819345
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy. The patient's understanding of his pathology and of the surgery was thus facilitated, leading to greater satisfaction during treatment.
For personalized medicine, it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship. Measuring health literacy help to identify and describe this heterogeneity in patient profiles. Patients with low literacy levels have higher levels of anxiety, particularly regarding surgery, and poorer post-operative recovery. Some studies highlight the importance of improving patient understanding with strategies to improve patients' health literacy and information provided by carers.
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool, all along the care pathway, on patients' experience and their interactions with carers, before and after partial nephrectomy.
To achieve this aim, 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized, in a 1:1 ratio, between the use of a personalized 3D kidney model and a generic 3D kidney model.
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation. All patients will complete questionnaires about their health literacy level, their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools. Semi-structured interviews will be conducted at three different times: between the first consultation with the surgeon and the preoperative education consultation, between this second consultation and the surgery and after the post-operative consultation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
personalized 3D kidney model
exchange time with the personalized 3D model of the kidney to be operated on as information support
personalized 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a personalized 3D models will be presented to the patients according to the allocated study group
generic 3D kidney model
exchange time with the generic 3D model of the kidney to be operated on as information support
generic 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a generic 3D models will be presented to the patients according to the allocated study group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
personalized 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a personalized 3D models will be presented to the patients according to the allocated study group
generic 3D model pré-opérative education
Before surgery, during a preoperative therapeutic education consultation, a generic 3D models will be presented to the patients according to the allocated study group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult patients (≥ 18 years of age)
* Scheduled for surgical management by laparoscopic robotic-assisted partial nephrectomy (1st management for a unilateral or bilateral kidney tumor)
* Expressed consent for integration in the UroCCR database
* Expressed consent for participation in the Rein-3D Personalize study
* Patients affiliated or benefiting from social security system
Professionals:
* Professionals working with patients treated in the Urology, Andrology and Renal Transplant - Department of the Bordeaux University Hospital for at least two months prior to the implementation of 3D models
* Free, informed and signed consent
Exclusion Criteria
* Metastatic at inclusion
* Previous renal cancer(s)
* Single kidney at time of inclusion
* No preoperative CT scan, or poor-quality CT scan unable to provide reliable 3D modeling
* Person under legal protection (safeguard of justice, guardianship or curatorship)
* Difficulty understanding and expressing oneself in French
Professionals
* Professionals on internship lasting less than 6 months
* Professionals with no contact with patients
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Bordeaux
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gaëlle MARGUE, Docteur
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Bordeaux
Bordeaux, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gaëlle MARGUE, Docteur
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Pattou M, Masanet S, Jutand MA, Hoarau H, Sarrazin J, Pitout A, Richert L, Larribere H, Rubat Baleuri F, Jaffredo M, Ricard S, Faessel M, Sabatier J, Bernhard JC, Margue G. Effects of a personalized or generic three-dimensional tumoral kidney model on patient experience and caregiver-patient interactions, before and after partial nephrectomy, a randomized trial (Rein 3D Print Personalize-UroCCR 114). PLoS One. 2025 Aug 18;20(8):e0323515. doi: 10.1371/journal.pone.0323515. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2023/78
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.