Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379698
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-19
Brief Title:
Rein 3D PRINT PERSONALIZE
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions Before and After Partial Nephrectomy
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R3DP-P
Brief Summary:
The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients tumoral kidney before and after nephron-sparing surgery The main outcome measure will be based on semi-structured interviews with the patient and the carers
Detailed Description:
The 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
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy The patients understanding of his pathology and of the surgery was thus facilitated leading to greater satisfaction during treatment
For personalized medicine it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship Measuring health literacy help to identify and describe this heterogeneity in patient profiles Patients with low literacy levels have higher levels of anxiety particularly regarding surgery and poorer post-operative recovery Some studies highlight the importance of improving patient understanding with strategies to improve patients health literacy and information provided by carers
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool all along the care pathway on patients experience and their interactions with carers before and after partial nephrectomy
To achieve this aim 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized in a 11 ratio between the use of a personalized 3D kidney model and a generic 3D kidney model
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation All patients will complete questionnaires about their health literacy level their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools Semi-structured interviews will be conducted at three different times between the first consultation with the surgeon and the preoperative education consultation between this second consultation and the surgery and after the post-operative consultation
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy The patients understanding of his pathology and of the surgery was thus facilitated leading to greater satisfaction during treatment
For personalized medicine it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship Measuring health literacy help to identify and describe this heterogeneity in patient profiles Patients with low literacy levels have higher levels of anxiety particularly regarding surgery and poorer post-operative recovery Some studies highlight the importance of improving patient understanding with strategies to improve patients health literacy and information provided by carers
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool all along the care pathway on patients experience and their interactions with carers before and after partial nephrectomy
To achieve this aim 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized in a 11 ratio between the use of a personalized 3D kidney model and a generic 3D kidney model
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation All patients will complete questionnaires about their health literacy level their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools Semi-structured interviews will be conducted at three different times between the first consultation with the surgeon and the preoperative education consultation between this second consultation and the surgery and after the post-operative consultation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None