Accuracy and usability of the navigation setup during rectal surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
rectum tumor chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determine the accuracy of the navigation setup.
Secondary outcome
To evaluate the usability of the system using post-operative questionnaires for
the surgeons.
Background summary
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.
Study objective
Accuracy and usability of the navigation setup during rectal surgery.
Study design
Before the start of the surgery, the patient will undergo a rectoscopy during
which two commercially available medical navigation sensors (Beacon®
Transponders) will be implanted inside the mesorectal fat adjacent to the
tumor. After implementation of the Beacon® Transponders, a standard
pre-operative CT-scan of the pelvic area is acquired in the OR, to determine
the location of the Beacon® Transponders with respect to the tumor.
During surgery, an in-house developed surgical navigation setup is placed close
to the patient, i.e. location of the tumor. The surgeon will have a pointer
that allows to determine the location of this pointer with respect to the
implanted transponders and thus tumor. 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 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.
All included patients are already scheduled for rectal surgery. The
programmed surgical procedure will not in any way be influenced by the
measurements, other than an extension of total operating time by a maximum of
20 minutes.
Study burden and risks
Burden low: marker implantation and CT scan
Risc low: Based on the HFMEA light, the potential risk was classified as *low*,
since the maximum risk-score was only 18 (on a scale 0-100).
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
• 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
Exclusion criteria
• Patients with a pacemaker
• Patients with metal implants in the pelvic area
• Patients for which it is impossible to do a rectal examination
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75929.031.20 |