Image-guide Surgery, Lymph Node Metastasis
Conditions
Brief summary
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
Detailed description
In the study patients will be randomized between the use of a surgical navigation system or not. The operation itself will be performed according to current clinical practice, and the navigation system will be used for better localization and orientation during the procedure.
Interventions
PROCEDURESurgical navigation
Patients will be operated with assistance of a navigation system
PROCEDUREConventional
Patients will be operated using the conventional technique
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for open abdominal surgery in which targeted removal of one or more pathological lymph nodes is part of the surgical plan
Exclusion criteria
* Metal implants in the pelvic area * Contra-indication for contrast enhanced CT scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of failed procedures | 3 months | Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical time to remove lymph node | After surgery | time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time, |
| LN success | 3 months | individual LN retrieval rate |
Countries
Netherlands
Outcome results
None listed