No registrations found.
ID
Source
Brief title
Health condition
Rectal tumor
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
Feasibility pilot study towards clinical implementation of a new navigation setup in which we can track the tumor within the rectum during surgery.
Study design
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
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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9432 |
| Other | METC : METC20.1194 |