No registrations found.
ID
Source
Brief title
Health condition
Prostate Cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of successful image-guide assisted sentinel node procedures, in which success is defined as removing all the pre-operatively identified SN.Failure of using the navigation would be either not removing a target SN or removing per-operatively incorrectly identified target SN.
Secondary outcome
• SUS-Score
• Time to localization and removal of the sentinel node
• Surgery time
• LN size vs success rate
Background summary
Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area. Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.
Study objective
Image-guided navigation surgery allows the optimal use and full integration of pre-operative images during surgical procedure. This feasibility study investigates the potential of this technique in surgery of robot assisted sentinel node procedures. The hypothesis is that with navigation surgeons have a better insight in the anatomy of the patient and can more easily find the lymph nodes. This will improve the decision making, and can potentially also speed up the procedures.
Study design
Primary outcome: extracted SN will be validated ex-vivo.
Secondary outcomes: after surgery questionnaires will be given to the surgeons for feedback; the rest of the outcomes will be annotated during surgery.
Intervention
Use of an electromagnetic navigation system to improve insight and orientation during pelvic surgery.
Inclusion criteria
• Scheduled for abdominal robotic sentinel node resection
• ≥ 18 years old
• Provided written ‘informed consent’
• Sentinel nodes should be fixed relative to retroperitoneal structures or major vessels
Exclusion criteria
• Metal hip implants/ implants in the pelvic area
• Pacemaker, defibrillator
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9865 |
| Other | METC AvL : METC21.0657/N21LND |