Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.

Study Overview
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Brief Summary
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Investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.

Detailed Description
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Announcement of serious illnesses and especially cancerous diseases 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 our research is to measure the effect of a personalized three-dimensional model of patients' kidney on pre-operative anxiety. For this purpose investigators will randomly assign a total of 66 patients planned to have a nephron-sparing surgery for kidney tumor in 3 different groups. Inside the 2 interventional groups, patients' kidneys will be modelized in three dimensions, one group will then be 3D-printed. The third group will be control with usual preoperative information. The day before surgery, 3D models will be presented to their respective owner. All patients will have to complete a survey evaluating their anxiety level and also their understanding of renal anatomy and surgical procedure.

Official Title
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Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.

Conditions
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Kidney Neoplasms, Carcinoma, Renal Cell

Intervention / Treatment
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* Other: Anxiety, renal anatomy and surgery questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients presenting with renal tumor allowing a nephron-sparing surgery Participating in UroCCR database Having a contrast abdominal scanner prior to surgery Owing social insurance contract Inpatient surgery Exclusion Criteria: Unable to give informed consent No contrast scanner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual modelization group<br>Patients having their kidney modelized in three dimensions on a software | Other: Anxiety, renal anatomy and surgery questionnaires<br>* The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire. A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients. Anxiolytics prescription prior to surgery will be collected inside the medical file.<br>|
| Experimental: Printed modelization group<br>Patients having their kidney modelized and printed in three dimensions | Other: Anxiety, renal anatomy and surgery questionnaires<br>* The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire. A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients. Anxiolytics prescription prior to surgery will be collected inside the medical file.<br>|
| Sham Comparator: Control group<br>No kidney model | Other: Anxiety, renal anatomy and surgery questionnaires<br>* The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire. A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients. Anxiolytics prescription prior to surgery will be collected inside the medical file.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire | Min : 20 = few anxiety Max : 80 = severe anxiety | The day before renal surgery, up to 1 month after inclusion | 
| Visual Analog Scale (VAS) score for anxiety | Min : 0 = no anxiety Max : 10 = maximum anxiety | The day before renal surgery, up to 1 month after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal anatomy and surgical strategies questionnaire score | Renal anatomy : min/max = 0/13, higher values represent a better understanding Surgical strategies : min/max = 0/7, higher values represent a better understanding | The day before renal surgery, up to 1 month after inclusion | 
| Anxiolytics prescription before surgery |  | The day before renal surgery, up to 1 month after inclusion | 
| Pain numeric scale score | Min : 0 = no pain Max : 10 = maximum pain | The day after renal surgery, up to 1 month after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Neoplasms, Carcinoma, Renal Cell, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, Personalized Medicine