Image-guided navigation surgery allows the optimal use and full integration of pre-operative images during surgical procedure. This feasibility study investigates the potential of this technique in surgery of robot assisted sentinel node procedures…
ID
Bron
Verkorte titel
Aandoening
Prostate Cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The percentage of successful image-guide assisted sentinel node procedures, in which success is defined as removing all the pre-operatively identified SN.Failure of using the navigation would be either not removing a target SN or removing per-operatively incorrectly identified target SN.
Achtergrond van het onderzoek
Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area. Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.
Doel van het onderzoek
Image-guided navigation surgery allows the optimal use and full integration of pre-operative images during surgical procedure. This feasibility study investigates the potential of this technique in surgery of robot assisted sentinel node procedures. The hypothesis is that with navigation surgeons have a better insight in the anatomy of the patient and can more easily find the lymph nodes. This will improve the decision making, and can potentially also speed up the procedures.
Onderzoeksopzet
Primary outcome: extracted SN will be validated ex-vivo.
Secondary outcomes: after surgery questionnaires will be given to the surgeons for feedback; the rest of the outcomes will be annotated during surgery.
Onderzoeksproduct en/of interventie
Use of an electromagnetic navigation system to improve insight and orientation during pelvic surgery.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Scheduled for abdominal robotic sentinel node resection
• ≥ 18 years old
• Provided written ‘informed consent’
• Sentinel nodes should be fixed relative to retroperitoneal structures or major vessels
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Metal hip implants/ implants in the pelvic area
• Pacemaker, defibrillator
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9865 |
| Ander register | METC AvL : METC21.0657/N21LND |