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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03943771

Recruitment Status Withdrawn (Schedule issue)

First Posted May 9, 2019

Last update posted January 27, 2020

Study Description

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.

  • Condition or Disease:Kidney Neoplasms
    Carcinoma, Renal Cell
  • Intervention/Treatment: Other: Anxiety, renal anatomy and surgery questionnaires
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Basic Science
  • Official Title: Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
  • Estimated Study Start Date: July 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
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.
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: The day before renal surgery, up to 1 month after inclusion ]
    Min : 20 = few anxiety Max : 80 = severe anxiety
  • 2. Visual Analog Scale (VAS) score for anxiety [ Time Frame: The day before renal surgery, up to 1 month after inclusion ]
    Min : 0 = no anxiety Max : 10 = maximum anxiety
  • Secondary Outcome Measures: 1. Renal anatomy and surgical strategies questionnaire score [ Time Frame: 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
  • 2. Anxiolytics prescription before surgery [ Time Frame: The day before renal surgery, up to 1 month after inclusion ]
  • 3. Pain numeric scale score [ Time Frame: The day after renal surgery, up to 1 month after inclusion ]
    Min : 0 = no pain Max : 10 = maximum pain
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

France
CHU de Bordeaux
Bordeaux

Sponsors and Collaborators

University Hospital, Bordeaux

More Information
  • Responsible Party: University Hospital, Bordeaux
  • ClinicalTrials.gov Identifier: NCT03943771 History of Changes
  • Other Study ID Numbers: CHUBX 2017/58
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: January 27, 2020
  • Last Verified: January 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University Hospital, Bordeaux: Kidney Neoplasms
    Carcinoma, Renal Cell
    Nephron-Sparing Surgery
    3D Modeling
    3D Printing
    Anxiety
    Personalized Medicine
  • Additional relevant MeSH terms: Carcinoma, Renal Cell Kidney Neoplasms