Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety (R3DP-A)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Tumoral Kidney

Treatments: Other: 3D model pré-operative education

Study type: Interventional

Funder types: Other

Identifiers

NCT06035211

CHUBX 2022/18

Details and patient eligibility

About

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.

Full description

Announcement of serious illnesses and especially cancerous disease has major impacts on one's psychological field. Need of surgery can create even other fears due to its unknown nature. 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. In the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated.

Technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. There is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. Some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. But none of these papers evaluated anxiety.

The goal of this research is to measure the effect of a personalized three-dimensional model of patients' tumoral kidney on peri-operative anxiety.

For this purpose this clinical trial is designed as following: a total of 234 (78*3) patients planned to have a nephron-sparing surgery for kidney tumor are going to be randomly assign in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelled in three dimensions, but in one of the two groups, the model will be 3D-printed. The control group will include patients for whom the pre-operative information will be made based on standardized information letter from the French Urological Association.

Before surgery, during a preoperative therapeutic education consultation, 3D models will be presented to the patients according to the allocated study group. All patients will have to complete questionnaires to assess their anxiety level, their quality of life, their health literacy level and their understanding of disease and surgical procedure.

One month after surgery, during the post-operative consultation, patients will also fill out the different questionnaires to assess their anxiety level, quality of life, and level of litteracy.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Virtual 3D model group

Active Comparator group

Description:

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

Treatment:

Other: 3D model pré-operative education

3D Printed Model Group

Active Comparator group

Description:

eexchange time with the printed three-dimensional model of the kidney to be operated on as information support

Treatment:

Other: 3D model pré-operative education

Control group

No Intervention group

Description:

discussion time with the patient information sheet of the French Association of Urology (AFU) as information support