Study Stopped
Schedule issue
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
R3DP-A
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJanuary 27, 2020
January 1, 2020
9 months
May 7, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Renal anatomy and surgical strategies questionnaire score
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
The day after renal surgery, up to 1 month after inclusion
Study Arms (3)
Virtual modelization group
EXPERIMENTALPatients having their kidney modelized in three dimensions on a software
Printed modelization group
EXPERIMENTALPatients having their kidney modelized and printed in three dimensions
Control group
SHAM COMPARATORNo kidney model
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to give informed consent
- No contrast scanner
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux
Bordeaux, 33076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
July 1, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
January 27, 2020
Record last verified: 2020-01