Feasibility of in vivo image-guided navigation during robotic sentinel node removal

Recruiting

Conditions: surgical and medical procedures - sentinel node dissection
Sentinel node metastasis

Registration Number: NL-OMON54304

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 55

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the feasibility of electromagnetic navigation during<br /><br>robot-assisted sentinel node dissection.<br /><br>Electromagnetic navigation is considered feasible if in 75% of the sentinel<br /><br>node procedures the technology can be applied successfully.<br /><br>In order to quantify the primary study parameter the percentage of successfully<br /><br>removed sentinel nodes will be taken into account. Success is defined when a<br /><br>sentinel node is correctly localized with navigation and perioperative<br /><br>validated with the gamma probe. Failure of using the navigation per sentinel<br /><br>node would be either not removing a target sentinel node or removing<br /><br>per-operatively incorrectly identified target sentinel node.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The first secondary study parameter is the time to localize and remove the<br /><br>sentinel node, together with the added time to surgery due to deploying<br /><br>navigation. The SUS-score will be used to evaluate the usability of the<br /><br>navigation within the surgery. The last study parameter will be the evaluation<br /><br>of the sentinel node size versus the success rate.</p><br>