Using 3D kidney models to reduce pre-operative anxiety before surgery
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A
This study is testing if using personalized 3D kidney models can help reduce anxiety for patients facing kidney surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT06035211 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of personalized three-dimensional models of patients' tumoral kidneys on pre-operative anxiety before nephron-sparing surgery. Patients will be randomly assigned to one of three groups: one receiving a 3D virtual model, another with a 3D printed model, and a control group receiving standard information. The primary outcome measure is the change in anxiety levels assessed using the STAI state score. The study aims to enhance patient understanding and satisfaction while addressing the psychological impact of surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for laparoscopic partial nephrectomy due to a unilateral kidney tumor.
Not a fit: Patients who do not speak or understand French or those without a preoperative CT scan for modeling may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pre-operative anxiety for patients undergoing kidney surgery.
How similar studies have performed: While there is evidence supporting the use of 3D modeling in surgical planning, this specific approach to reducing anxiety has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years of age) * Scheduled surgical management by laparoscopic partial nephrectomy with robotic assistance for kidney tumor * Unilateral kidney tumor or 1st surgery for bilateral involvement * Consent expressed for integration of the UroCCR cohort, * Expressed consent for participation in the 3D Anxiety study. * Patients affiliated or benefiting from a social security plan Exclusion Criteria: * Refusal of consent or participation * Difficulty understanding and expressing oneself in French * Patient under guardianship or curatorship * No preoperative CT scan available for 3D modeling
Where this trial is running
Angers and 5 other locations
- CHU d'ANGERS — Angers, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CHU de CAEN — Caen, France (Recruiting)
- Hôpital Kremlin-Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
- CHU de La CONCEPTION — Marseille, France (Recruiting)
- CHU de NANTES — Nantes, France (Recruiting)
Study contacts
- Principal investigator: Jean-Christophe BERNHARD, Professeur — University Hospital, Bordeaux
- Study coordinator: Jean-Christophe BERNHARD, Professeur
- Email: jean-christophe.bernhard@chu-bordeaux.fr
- Phone: 05 57 82 03 50
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.