Rectal cancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: * Patients with metal implants in the pelvic area * Patients for which it is impossible to do a rectal examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study we aim to evaluate feasibility of the navigation system during real-time tumour tracking in rectal surgery. Feasibility will be primarily evaluated by judging the successful delivery of interpretable navigation data per procedure. In addition, we will record the extra time needed; the easiness to glue the sensor to the tumour and the satisfactory scores of the surgeons on the additional value of tumour tracking with respect to rigid navigation (N13NAV). | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy of the navigation towards anatomical landmarks: Optical identification of anatomical landmarks are used to validate this accuracy. By hovering the blunt tip probe over the landmarks, post processing can determine the error of the navigated probe tip and the segmented landmarks. Correlation of navigation with echography: The outcome measure will be a difference in distance (mm) where the navigation system measures the location of the distal tumour border from the sutures/clips on the excised rectum specimen and the same distance is measured with ultrasound. | — |
Countries
Netherlands
Outcome results
None listed