Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-13
Brief Title:
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
3D-PEDSURG
Brief Summary:
This studys purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation based on the Dice precision index It is implemented by making parents patients surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patients tumor
Detailed Description:
The investigator will inform the child and his parents during the pre-surgical consultation and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan Patients requiring emergency imaging will not be included
Pelvic tumors will benefit from MRI imaging and renal tumors from MRI andor CT scan
A CT scan will be carried out for retroperitoneal tumors other than renal tumors mainly neuroblastomas
All of the above examinations are carried out as part of the usual treatment in the month preceding the surgery
Pre-operatively After the imaging has been carried out the 2D images will be presented to the patient and his family before surgery as it is done routinely The 3D image will be showed afterwards The family will have the opportunity to ask questions which the surgeon will answer as usually done
The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team
Once the patient is included and the examinations have been carried out the operating surgeons and their assistants help No 1 and 2 will look at the 2D images followed by the 3D images secondly a few days before surgery They will complete the specific questionnaire and give it to the research team
Once the patient is included and the imaging examinations have been carried out surgeons external to the service will be contacted by the research team to organize a remote review session The 2D images will be presented to them first followed by the 3D images on the visualization software via a remote communication system with screen sharing They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post
Intraoperatively
The 3D model of the patient will be displayed in the operating room andor integrated into the robots display console for robot-assisted surgeries during the surgical procedure At the end of the surgery the operating surgeon and his assistants will complete independently a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model
Pelvic tumors will benefit from MRI imaging and renal tumors from MRI andor CT scan
A CT scan will be carried out for retroperitoneal tumors other than renal tumors mainly neuroblastomas
All of the above examinations are carried out as part of the usual treatment in the month preceding the surgery
Pre-operatively After the imaging has been carried out the 2D images will be presented to the patient and his family before surgery as it is done routinely The 3D image will be showed afterwards The family will have the opportunity to ask questions which the surgeon will answer as usually done
The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team
Once the patient is included and the examinations have been carried out the operating surgeons and their assistants help No 1 and 2 will look at the 2D images followed by the 3D images secondly a few days before surgery They will complete the specific questionnaire and give it to the research team
Once the patient is included and the imaging examinations have been carried out surgeons external to the service will be contacted by the research team to organize a remote review session The 2D images will be presented to them first followed by the 3D images on the visualization software via a remote communication system with screen sharing They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post
Intraoperatively
The 3D model of the patient will be displayed in the operating room andor integrated into the robots display console for robot-assisted surgeries during the surgical procedure At the end of the surgery the operating surgeon and his assistants will complete independently a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02070-45 | OTHER | ID-RCB | None |