Navigated Abdominal Lymph Node Dissections (N16LND)

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Image-guide Surgery; Lymph Node Metastasis

Treatments: Procedure: Surgical navigation; Procedure: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT05867095

N16LND

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Navigation

Experimental group

Description:

Patients will get the standard of care in the Netherlands with the addition of surgical navigation

Treatment:

Procedure: Surgical navigation

Conventional

Other group

Description:

Patients will get the standard of care in the Netherlands

Treatment:

Procedure: Conventional