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

Not Applicable

Withdrawn

• Conditions: Carcinoma, Renal Cell; Kidney Neoplasms
• Interventions: Other: Anxiety, renal anatomy and surgery questionnaires

• Registration Number: NCT03943771
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2019-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Printed modelization group	Anxiety, renal anatomy and surgery questionnaires	Patients having their kidney modelized and printed in three dimensions
Control group	Anxiety, renal anatomy and surgery questionnaires	No kidney model
Virtual modelization group	Anxiety, renal anatomy and surgery questionnaires	Patients having their kidney modelized in three dimensions on a software

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France