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

Carcinoma, Renal Cell Clinical Trial

— R3DP-A  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03943771
• Other study ID #: CHUBX 2017/58
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: April 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Anxiolytics prescription before surgery		The day before renal surgery, up to 1 month after inclusion
Secondary	Pain numeric scale score	Min : 0 = no pain Max : 10 = maximum pain	The day after renal surgery, up to 1 month after inclusion