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Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. (R3DP-A)

Primary Purpose

Kidney Neoplasms, Carcinoma, Renal Cell

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anxiety, renal anatomy and surgery questionnaires
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Neoplasms focused on measuring Kidney Neoplasms, Carcinoma, Renal Cell, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, Personalized Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Virtual modelization group

Printed modelization group

Control group

Arm Description

Patients having their kidney modelized in three dimensions on a software

Patients having their kidney modelized and printed in three dimensions

No kidney model

Outcomes

Primary Outcome Measures

State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
Min : 20 = few anxiety Max : 80 = severe anxiety
Visual Analog Scale (VAS) score for anxiety
Min : 0 = no anxiety Max : 10 = maximum anxiety

Secondary Outcome Measures

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
Anxiolytics prescription before surgery
Pain numeric scale score
Min : 0 = no pain Max : 10 = maximum pain

Full Information

First Posted
May 7, 2019
Last Updated
January 22, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03943771
Brief Title
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
Acronym
R3DP-A
Official Title
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Schedule issue
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms, Carcinoma, Renal Cell
Keywords
Kidney Neoplasms, Carcinoma, Renal Cell, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, Personalized Medicine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual modelization group
Arm Type
Experimental
Arm Description
Patients having their kidney modelized in three dimensions on a software
Arm Title
Printed modelization group
Arm Type
Experimental
Arm Description
Patients having their kidney modelized and printed in three dimensions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No kidney model
Intervention Type
Other
Intervention Name(s)
Anxiety, renal anatomy and surgery questionnaires
Intervention Description
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.
Primary Outcome Measure Information:
Title
State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
Description
Min : 20 = few anxiety Max : 80 = severe anxiety
Time Frame
The day before renal surgery, up to 1 month after inclusion
Title
Visual Analog Scale (VAS) score for anxiety
Description
Min : 0 = no anxiety Max : 10 = maximum anxiety
Time Frame
The day before renal surgery, up to 1 month after inclusion
Secondary Outcome Measure Information:
Title
Renal anatomy and surgical strategies questionnaire score
Description
Renal anatomy : min/max = 0/13, higher values represent a better understanding Surgical strategies : min/max = 0/7, higher values represent a better understanding
Time Frame
The day before renal surgery, up to 1 month after inclusion
Title
Anxiolytics prescription before surgery
Time Frame
The day before renal surgery, up to 1 month after inclusion
Title
Pain numeric scale score
Description
Min : 0 = no pain Max : 10 = maximum pain
Time Frame
The day after renal surgery, up to 1 month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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

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