The purpose of the study is to test the feasibility of image-guided navigation during robot-assisted sentinel node dissection.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
surgical and medical procedures - sentinel node dissection
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the feasibility of electromagnetic navigation during
robot-assisted sentinel node dissection.
Electromagnetic navigation is considered feasible if in 75% of the sentinel
node procedures the technology can be applied successfully.
In order to quantify the primary study parameter the percentage of successfully
removed sentinel nodes will be taken into account. Success is defined when a
sentinel node is correctly localized with navigation and perioperative
validated with the gamma probe. Failure of using the navigation per sentinel
node would be either not removing a target sentinel node or removing
per-operatively incorrectly identified target sentinel node.
Secondary outcome
The first secondary study parameter is the time to localize and remove the
sentinel node, together with the added time to surgery due to deploying
navigation. The SUS-score will be used to evaluate the usability of the
navigation within the surgery. The last study parameter will be the evaluation
of the sentinel node size versus the success rate.
Background summary
Image-guided navigation surgery allows for full utilization of pre-operative
imaging during open surgery, and has the potential of reducing both irradical
resections and morbidity. Rapid extension of robot-assisted surgery has
increased the need for robot-compliant image-guided techniques. This is the
first feasibility study towards clinical implementation of the navigation setup
into robot-assisted image-guided navigation surgery.
Study objective
The purpose of the study is to test the feasibility of image-guided navigation
during robot-assisted sentinel node dissection.
Study design
Investigator initiated, prospective, non-randomized, feasibility study
Study burden and risks
The burden due to participation in the study is limited to an intra-operative
CBCT scan, an US scan and prolonged surgery time (about 15 minutes for the CBCT
or 5 minutes for the US). Only for the first 25 patients, due to the CBCT scan
the patient will be exposed to some radiation (4 mSv). The risks associated
with the extended operation time are considered limited, taking into account
the duration of the operation.
No extra visits or interventions are associated with inclusion in the study.
The surgical intervention will not be different from a routine robot-assisted
sentinel node dissection.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for abdominal robotic sentinel node resection
- >= 18 years old
- Provided written *informed consent*
- SN should be fixed relative to retroperitoneal structures or major vessels
Exclusion criteria
- Metal hip implants / implants in the pelvic area
- Pacemaker, defibrillator
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 | NL77462.031.21 |