Kidney NeoplasmsR3DP-ANCT03943771
Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
A study testing Anxiety, renal anatomy and surgery questionnaires in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms, Carcinoma, Renal Cell
- What is being tested?
- Anxiety, renal anatomy and surgery questionnaires
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to give informed consent
- No contrast scanner
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Being tested
- Anxiety, renal anatomy and surgery questionnaires
- Keywords
- Kidney Neoplasms, Carcinoma, Renal Cell, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, Personalized Medicine
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety, renal anatomy and surgery questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual modelization group | Experimental | Patients having their kidney modelized in three dimensions on a software Receives: Other: Anxiety, renal anatomy and surgery questionnaires |
| Printed modelization group | Experimental | Patients having their kidney modelized and printed in three dimensions Receives: Other: Anxiety, renal anatomy and surgery questionnaires |
| Control group | Sham comparator | No kidney model Receives: Other: Anxiety, renal anatomy and surgery questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire
Min : 20 = few anxiety Max : 80 = severe anxiety
Measured: 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
Measured: The day before renal surgery, up to 1 month after inclusion
Secondary outcomes (3)
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
Measured: The day before renal surgery, up to 1 month after inclusion
Anxiolytics prescription before surgery
Measured: The day before renal surgery, up to 1 month after inclusion
Pain numeric scale score
Min : 0 = no pain Max : 10 = maximum pain
Measured: The day after renal surgery, up to 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study startJul 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Schedule issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943771
- Sponsor's protocol ID
- CHUBX 2017/58
- Acronym
- R3DP-A
- Status last verified
- Jan 2020
- First submitted
- 7 May 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor.
- ClinicalTrials.gov ID
- NCT03943771
- Acronym / sponsor ID
- R3DP-A / CHUBX 2017/58
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Keywords
- Kidney Neoplasms, Carcinoma, Renal Cell, Nephron-Sparing Surgery, 3D Modeling, 3D Printing, Anxiety, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Schedule issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual modelization group | Experimental | Other: Anxiety, renal anatomy and surgery questionnairesPatients having their kidney modelized in three dimensions on a software |
| Printed modelization group | Experimental | Other: Anxiety, renal anatomy and surgery questionnairesPatients having their kidney modelized and printed in three dimensions |
| Control group | Sham comparator | Other: Anxiety, renal anatomy and surgery questionnairesNo kidney model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to give informed consent
- No contrast scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety, renal anatomy and surgery questionnairesThe 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. | Other | Control group, Printed modelization group, Virtual modelization group |
Primary outcome
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
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
3 secondary outcomes
Renal anatomy and surgical strategies questionnaire score
Time frame: The day before renal surgery, up to 1 month after inclusion
Anxiolytics prescription before surgery
Time frame: The day before renal surgery, up to 1 month after inclusion
Pain numeric scale score
Time frame: The day after renal surgery, up to 1 month after inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety, renal anatomy and surgery questionnaires in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-anxiety score of the State-Trait Anxiety Inventory (STAI) questionnaire (time frame: The day before renal surgery, up to 1 month after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.