Targeted Abdominal Lymph nodE dissections randomized for surgical NavigaTion (TALENT)
Completed
- Conditions
- Abdominal pathologic lymph nodes1002747610025309
- Registration Number
- NL-OMON50713
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
Age * 18
Scheduled for open abdominal surgery
Planned removal of at least 1 extra-regional lymph node suspect on imaging, as
assessed by the specialist who will perform the operation
Informed consent
Exclusion Criteria
Metal implants in the pelvic area which could influence the 3D modelling or
navigation accuracy
Contra-indication for contrast enhanced CT scanning
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary:<br /><br>The main study parameter is the percentage of successful procedures, in which<br /><br>failure is defined as :<br /><br>Presence of residual target lymph nodes on follow-up imaging</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary:<br /><br>* Time to localization and removal of the lymph node<br /><br>* Overall surgery time<br /><br>* Number of individual retreived lymph nodes<br /><br>* Blood loss<br /><br>* Operator satisfaction<br /><br>* Health related quality of life (EQ-5D-5L, QLQ-C30, and QLQ-CR29 or QLQ-PR25)</p><br>