No registrations found.
ID
Source
Brief title
Health condition
Open or laparoscopic surgery for rectal cancer patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The secondary outcome was accuracy of the system.
Background summary
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.
Study objective
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.
Study design
N/A
Intervention
Use of an electromagnetic navigation system to improve insight and orientation during pelvic surgery.
Inclusion criteria
≥ 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)
Exclusion criteria
Metal implants in the pelvic area
Patients for which it is impossible to do a rectal examination
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7666 |
| CCMO | NL57251.031.16 |
| OMON | NL-OMON47238 |