Rein 3D PRINT PERSONALIZE (R3DP-P)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Tumoral Kidney

Treatments: Other: personalized 3D model pré-opérative education; Other: generic 3D model pré-opérative education

Study type: Interventional

Funder types: Other

Identifiers

NCT06379698

CHUBX 2023/78

Details and patient eligibility

About

The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers.

Full description

The use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now.

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

personalized 3D kidney model

Active Comparator group

Description:

exchange time with the personalized 3D model of the kidney to be operated on as information support

Treatment:

Other: personalized 3D model pré-opérative education

generic 3D kidney model

Active Comparator group

Description:

exchange time with the generic 3D model of the kidney to be operated on as information support

Treatment:

Other: generic 3D model pré-opérative education