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

Targeted Abdominal Lymph nodE dissections randomized for surgical NavigaTion (TALENT) - Navigated abdominal lymph node dissections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50713

Enrollment

Registered

2016-10-27

Start date

2017-01-24

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal pathologic lymph nodes

Interventions

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 sy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Metal implants in the pelvic area which could influence the 3D modelling or navigation accuracy Contra-indication for contrast enhanced CT scanning

Design outcomes

Primary

Measure	Time frame
Primary: The main study parameter is the percentage of successful procedures, in which failure is defined as : Presence of residual target lymph nodes on follow-up imaging	—

Secondary

Measure	Time frame
Secondary: • Time to localization and removal of the lymph node • Overall surgery time • Number of individual retreived lymph nodes • Blood loss • Operator satisfaction • Health related quality of life (EQ-5D-5L, QLQ-C30, and QLQ-CR29 or QLQ-PR25)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)