Using personalized 3D kidney models to improve patient experience before surgery
Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions, Before and After Partial Nephrectomy
This study is testing whether using personalized 3D kidney models can help patients feel more informed and less anxious before their kidney surgery compared to using standard models.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06379698 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of personalized versus generic 3D printed models of patients' tumoral kidneys in enhancing preoperative education and reducing anxiety before nephron-sparing surgery. The study will involve 60 adult patients scheduled for robot-assisted laparoscopic partial nephrectomy, who will be randomized to receive either a personalized or generic 3D model. The primary outcome will be assessed through semi-structured interviews with patients and their caregivers, focusing on their understanding and satisfaction with the surgical process. The trial seeks to address the importance of health literacy and personalized care in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for laparoscopic robotic-assisted partial nephrectomy for unilateral or bilateral kidney tumors.
Not a fit: Patients with metastatic disease, previous renal cancers, or those with a single kidney may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient understanding and satisfaction, leading to better surgical outcomes and recovery.
How similar studies have performed: Previous pilot studies have shown positive outcomes using personalized 3D-printed models in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients: * 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: Patients * 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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Gaëlle MARGUE, Docteur — University Hospital, Bordeaux
- Study coordinator: Gaëlle MARGUE, Dr
- Email: gaelle.margue@chu-bordeaux.fr
- Phone: 00335 57 82 17 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.