Targeted Abdominal Lymph nodE dissections randomized for surgical NavigaTion (TALENT)

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. In this study we will randomize patients
which will undergo an abdominal lymph node dissection in order to evaluate the
actual technical and clinical benefit of navigation

To evaluate if navigation assistance results in more successful localization
and removal of extra-regional abdominal lymph nodes compared to standard
surgery. Extra regional lymph nodes are defined as suspect target lymph nodes
outside the standard resection area.

Randomized controlled trial with stratification for surgical specialism
(surgery, urology, gynaecology)

In the study patients will be randomized between the use of a surgical
navigation system or not. The operation itself will be perforemed according to
current clinical practice, and the navigation system will be used for better
localization and orientation during the procedure.

All included patients will undergo one pre-operative planning CT scan with
intravenous contrast (10 min). Participation in the study might involve an
additional visit to the hospital for the included patients due to challenging
CT scheduling. Patients in the experimental arm will also undergo one
intra-operative CT scan just before the start of surgery without intravenous
contrast (10 min). This will be done with the patient anesthesized, which means
an extension of anesthesia by 10 minutes.

Because of the nature of this study we do not expect any adverse events to
occur due to the study related procedures. The navigation system is there to
enhance the anatomical insight without any negative impact on standard surgery.