Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety

Recruiting now · Not applicable

Conditions studied: Tumoral Kidney

In brief

The goal of this clinical trial is to evaluate the impact of showing and handling a three-dimensional modelization of a patient's tumoral kidney the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D printed model, and information) using a randomization.

Key facts

Study ID

NCT06035211

Run by

University Hospital, Bordeaux

People needed

192

Starts

2023-09-19

Expected to finish

2026-01-01

Last updated by the study team

2025-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• CHU d'ANGERS — Angers, France (enrolling)
• CHU de Bordeaux — Bordeaux, France (enrolling)
• CHU de CAEN — Caen, France (enrolling)
• Hôpital Kremlin-Bicêtre — Le Kremlin-Bicêtre, France (enrolling)
• CHU de La CONCEPTION — Marseille, France (enrolling)
• CHU de NANTES — Nantes, France (enrolling)

Full record on ClinicalTrials.gov

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