Clinical trial NCT03943771: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Neoplasms
Carcinoma, Renal Cell
Keywords: Kidney Neoplasms
Carcinoma, Renal Cell
Nephron-Sparing Surgery
3D Modeling
3D Printing
Anxiety
Personalized Medicine
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
timeFrame: The day before renal surgery, up to 1 month after inclusion
measure: Visual Analog Scale (VAS) score for anxiety
timeFrame: The day before renal surgery, up to 1 month after inclusion
Secondary outcomes:
measure: Renal anatomy and surgical strategies questionnaire score
timeFrame: The day before renal surgery, up to 1 month after inclusion
measure: Anxiolytics prescription before surgery
timeFrame: The day before renal surgery, up to 1 month after inclusion
measure: Pain numeric scale score
timeFrame: The day after renal surgery, up to 1 month after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: