Targeted Abdominal Lymph nodE Dissections Randomized for Surgical NavigaTion (TALENT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Number of failed procedures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Navigation
Patients will get the standard of care in the Netherlands with the addition of surgical navigation
Intervention: Surgical navigation (Procedure)
Conventional
Patients will get the standard of care in the Netherlands
Intervention: Conventional (Procedure)
Outcomes
Primary Outcomes
Number of failed procedures
Time Frame: 3 months
Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging
Secondary Outcomes
- Surgical time to remove lymph node(After surgery)
- LN success(3 months)