To test the feasibility of image-guided navigation during robot-assisted prostatectomy
ID
Source
Brief title
Condition
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the feasibility of electromagnetic navigation during
RARP. Electromagnetic navigation is considered feasible if in 85% of patients
the technology can be applied successfully.
A successful procedure includes: 1) successful placement of the EM sensors in
the prostate and 2) accurate registration between the pre-operative 3D model of
the patient and intra-operative situation. The registration is considered
accurate if the mean target registration error is 1.0 cm or less. For assessing
the accuracy of the registrations a set of independent positions of pre-defined
anatomical structures and surfaces is used.
Secondary outcome
The first secondary study parameter is the added time to surgery due to
deploying navigation. The second secondary study parameter is the accuracy of
the different registration methods.
Background summary
Incomplete tumor resection or positive surgical margins are observed in up to
29% of specimens during histopathological evaluation of the specimens of
patients treated with robot-assisted radical prostatectomy (RARP). Positive
resection margins are associated with biochemical recurrence of the disease and
require additional treatment post-surgery. Image-guided navigation, using
pre-operative imaging, can help the surgeon with recognizing the border of the
prostate and the tumor thereby avoiding incomplete resection and positive
resection margins. This could lead to improved surgical outcomes.
Study objective
To test the feasibility of image-guided navigation during robot-assisted
prostatectomy
Study design
Investigator initiated, prospective, non-randomized, feasibility study
Study burden and risks
The burden due to participation in the study are limited to a prolonged surgery
time (10-15 minutes). Risks related to the prolonged surgery time are
considered limited taking in consideration the duration of the surgery.
No extra visits or interventions are associated with inclusion in the study.
The surgical intervention will not be different from a routine robot-assisted
radical prostatectomy.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- >= 18 years old
- Scheduled for robot-assisted radical prostatectomy
- Biopsy-proven prostate carcinoma
- Available pre-operative MRI of sufficient quality for making the 3D model
- Written and signed informed consent
Exclusion criteria
- Allergic reaction to contrast agents in the past
- Metal implants in the pelvic area
- Defibrillator or pacemaker implant
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL76713.031.21 |