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 new technique in surgery of pelvic malignancies. The…
ID
Bron
Verkorte titel
Aandoening
Open surgery for one of the following:
Locally advanced rectal tumors invading the pelvic wall
Local recurrences (of any origin) within the pelvic space
Extramesorectal pathologic lymph nodes in the pelvic space
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Safety and feasibility: number of procedures where the system was used, and the additional surgery time due to use of the system.
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. This is the first pilot study of a novel navigation system evaluated in surgery of malignancies within the pelvis
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 new technique in surgery of pelvic malignancies.
The hypothesis is that with navigation surgeons have a better insight in the anatomy of the patient. This will improve the decision making, and can potentially also speed up the procedures. Ultimately, sugical outcome in terms of radicality and morbidity can be improved.
Onderzoeksopzet
N/A
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)
≥ 18 years
A signed informed consent
Suitable for contrast enhanced CT scanning
abdominal surgery by laparotomy
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Metal hip implants
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6994 |
| NTR-old | NTR7184 |
| CCMO | NL43553.031.13 |
| OMON | NL-OMON47658 |