Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation | Experimental | Patients will get the standard of care in the Netherlands with the addition of surgical navigation |
|
| Conventional | Other | Patients will get the standard of care in the Netherlands |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical navigation | Procedure | Patients will be operated with assistance of a navigation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of failed procedures | Failed procedure is defined as: presence of any residual target lymph node on follow-up imaging | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time to remove lymph node | time from having the surgical field prepared for lymph node localization to actual removal of the lymph node, overall surgical time, | After surgery |
| LN success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | North Holland | 1066 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39737148 | Derived | Groen HC, Wit EMK, Heerink WJ, Kuhlmann KFD, Nijkamp JA, van Veen R, Schoots IG, Balduzzi S, Zijlmans HJMAA, van Leeuwen PJ, van der Poel HG, Ruers TJM. Surgical navigation for targeted retroperitoneal lymph-node removal: a randomised, controlled, phase 3 trial. EClinicalMedicine. 2024 Jul 26;74:102754. doi: 10.1016/j.eclinm.2024.102754. eCollection 2024 Aug. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional | Procedure | Patients will be operated using the conventional technique |
|
individual LN retrieval rate
| 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |