Feasibility pilot study towards clinical implementation of a new navigation setup in which we can track the tumor within the rectum during surgery.
ID
Bron
Verkorte titel
Aandoening
Rectal tumor
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Determine the accuracy of the navigation setup
Achtergrond van het onderzoek
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 caused by damaged surrounding structures. This is a feasibility pilot study towards clinical implementation of a new navigation setup in which we can track the tumor within the rectum during surgery.
Doel van het onderzoek
Feasibility pilot study towards clinical implementation of a new navigation setup in which we can track the tumor within the rectum during surgery.
Onderzoeksopzet
Primary outcome:
The surgeon will place standard surgical clips on the resection plane during surgery. The position of these clips are saved by touching the clips with the navigation pointer tip. After the specimen is excised, it will be probed using the navigation setup to acquire additional ex vivo distance measurements. These distance measurements will be compared to pathology measurements to determine the accuracy of the navigation setup.
Secondary outcome:
The usability of the system is assessed by post-operative questionnaires for the surgeons
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The patient is planned for low anterior resection (LAR) or abdominoperineal resection (APR)
Rectal tumors (based on preoperative imaging)
Signed informed consent
Patients ≥ 18 years old
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with a pacemaker
Patients with metal implants in the pelvic area
Patients for which it is impossible to do a rectal examination
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9432 |
| Ander register | METC : METC20.1194 |