Real-time in vivo sensor tracking of rectal tumours during colorectal cancer surgery
Completed
- Conditions
- Rectal cancer1001799110017998
- Registration Number
- NL-OMON47238
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
* The patient is planned for rectal surgery by laparotomy or laparoscopy
* The tumour should be within 10 cm of the anal verge
* Signed informed consent
* Patients * 18 years old
Exclusion Criteria
* Patients with metal implants in the pelvic area
* Patients for which it is impossible to do a rectal examination
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In this study we aim to evaluate feasibility of the navigation system during<br /><br>real-time tumour tracking in rectal surgery.<br /><br>Feasibility will be primarily evaluated by judging the successful delivery of<br /><br>interpretable navigation data per procedure. In addition, we will record the<br /><br>extra time needed; the easiness to glue the sensor to the tumour and the<br /><br>satisfactory scores of the surgeons on the additional value of tumour tracking<br /><br>with respect to rigid navigation (N13NAV).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Accuracy of the navigation towards anatomical landmarks:<br /><br>Optical identification of anatomical landmarks are used to validate this<br /><br>accuracy. By hovering the blunt tip probe over the landmarks, post processing<br /><br>can determine the error of the navigated probe tip and the segmented landmarks.<br /><br><br /><br>Correlation of navigation with echography:<br /><br>The outcome measure will be a difference in distance (mm) where the navigation<br /><br>system measures the location of the distal tumour border from the sutures/clips<br /><br>on the excised rectum specimen and the same distance is measured with<br /><br>ultrasound.</p><br>