Feasibility of in Vivo Image-guided Navigation During Robotic Sentinel Node Removal
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- The Netherlands Cancer Institute
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Feasibility of image-guide assisted sentinel node removal
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery, and has the potential of reducing both irradical resections and morbidity. It has successfully been applied in the AvL for open abdominal surgery, however more and more surgeries are being performed less invasive using robot surgery. Rapid extension of robot-assisted surgery has increased the need for robot-compliant image-guided techniques. Unfortunately, tactile feedback is lacking in these robotic surgeries, which increases the additional value of image-guided navigation. In this study, patients will undergo an abdominal sentinel node dissection in order to evaluate the actual technical benefit of robotic navigation. This is the first feasibility study towards clinical implementation of the navigation setup into robot-assisted image-guided navigation surgery. The results of this study will be the base for new studies, evaluating the clinical benefit of image-guided navigation for robot surgeries.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Feasibility of image-guide assisted sentinel node removal
Time Frame: One day
The percentage of successful image-guide assisted sentinel nodes removed, in which failure is defined as sentinel nodes which are per-operatively incorrectly identified as target SN by the navigation.
Secondary Outcomes
- Usability of image-guided navigation(One day)
- Time(One day)