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

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.

Study Overview

• Status: Withdrawn
• Conditions: Kidney Neoplasms; Carcinoma, Renal Cell
• Intervention / Treatment: Other: Anxiety, renal anatomy and surgery questionnaires

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual modelization group; Patients having their kidney modelized in three dimensions on a software	Other: Anxiety, renal anatomy and surgery questionnaires; 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.
Experimental: Printed modelization group; Patients having their kidney modelized and printed in three dimensions	Other: Anxiety, renal anatomy and surgery questionnaires; 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.
Sham Comparator: Control group; No kidney model	Other: Anxiety, renal anatomy and surgery questionnaires; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety; Kidney Neoplasms; Carcinoma, Renal Cell; Nephron-Sparing Surgery; 3D Modeling; 3D Printing; Personalized Medicine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: CHUBX 2017/58

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No