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 in rectal surgery. The hypothesis is…
ID
Bron
Verkorte titel
Aandoening
Open or laparoscopic surgery for rectal cancer patients
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of this study was feasibility. Feasibility was defined as successful completion of the whole investigational workflow resulting in continuous delivery of interpretable navigation data for rectal surgery.
Achtergrond van het onderzoek
Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery. It has the potential of reducing irradical resection margins and reducing morbidity caused by damaged surrounding structures. We have developed a navigation system that can take positional changes of the tumour into account by using a tracking sensor fixed to the tumour or its surrounding tissue. This is a feasibility pilot study towards clinical implementation of this new navigation system.
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 in rectal surgery.
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 rectal tumour within 10 cm of the anal verge (based on preoperative imaging)
A signed informed consent
Suitable for contrast enhanced CT scanning
Planned for low anterior resection (LAR) or abdominoperineal resection (APR)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Metal implants in the pelvic area
Patients for which it is impossible to do a rectal examination
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7666 |
| CCMO | NL57251.031.16 |
| OMON | NL-OMON47238 |