Image-guided navigation during robotic soft tissue surgery: a pilot study

Conditions: lymfeklieren
lymph node surgery
Tumor surgery
10017990
10038430

Registration Number: NL-OMON49610

Lead Sponsor: Chirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

· Patients who are scheduled for open (phase 1) or (robot assisted)
laparoscopic (phase 2) soft tissue surgery,
· Locally advanced T3 or T4 tumor, local recurrent tumor or lymph node
metastasis,
· Patients should be suitable for contrast enhanced CT scanning,
· A signed informed consent
· Patients * 18 years old

Exclusion Criteria

- patients with metal implants in the area that needs to be scanned
- patients with a pacemaker
- pregnancy

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility, safety and efficacy of the image-guided navigation system during<br /><br>soft tissue surgery, first in open procedures (safety phase) and secondly in<br /><br>laparoscopic and robot assisted procedures (efficacy phase).<br /><br><br /><br>Fefasibility will be monitord through successful implementation of the<br /><br>navigation technology during laparoscopic and robot-assisted surgery.<br /><br><br /><br>Safety will be monitored through registration of complications during surgery<br /><br>related to the use of the technology<br /><br><br /><br>Efficacy will be monitored throug clinical outcome parameters (I) target(s)<br /><br>removed, (II) radicality of tumor removed, (III) operative morbidity and time<br /><br>to regain functionality of clinically relevant indicators.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluation of the total time needed to perform image guided surgery.<br /><br><br /><br>To be (additionally) registered en montoring times are (I) time needed to<br /><br>prepare the set-up and perform CBCT-scan, (II) time needed to remove target,<br /><br>(III) total operating time.</p><br>