Primary: Feasibility of an in-house developed electromagnetic navigation system during real-time tumour tracking in rectal surgery.Secondary: Evaluation of the accuracy of the system. * Determine the accuracy of the navigation system relative to…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study we aim to evaluate feasibility of the navigation system during
real-time tumour tracking in rectal surgery.
Feasibility will be primarily evaluated by judging the successful delivery of
interpretable navigation data per procedure. In addition, we will record the
extra time needed; the easiness to glue the sensor to the tumour and the
satisfactory scores of the surgeons on the additional value of tumour tracking
with respect to rigid navigation (N13NAV).
Secondary outcome
Accuracy of the navigation towards anatomical landmarks:
Optical identification of anatomical landmarks are used to validate this
accuracy. By hovering the blunt tip probe over the landmarks, post processing
can determine the error of the navigated probe tip and the segmented landmarks.
Correlation of navigation with echography:
The outcome measure will be a difference in distance (mm) where the navigation
system measures the location of the distal tumour border from the sutures/clips
on the excised rectum specimen and the same distance is measured with
ultrasound.
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. This is the first study to implement a surgical
image-guided EM navigation system in which traceable sensors are glued on or
near the tumor to provide the surgeons with real-time information on the tumor
location and orientation.
Study objective
Primary:
Feasibility of an in-house developed electromagnetic navigation system during
real-time tumour tracking in rectal surgery.
Secondary:
Evaluation of the accuracy of the system.
* Determine the accuracy of the navigation system relative to anatomical
landmarks during surgery by correlation of probe measurements to visual
inspection.
* Determine the accuracy of the distance from the probe tip to the tumour. To
determine this accuracy we correlate these results with ultrasound of the
excised specimen.
Study design
An observational feasibility study.
Study burden and risks
Because of the nature of this study, we do not expect any adverse events to
occur that are related to the intervention. Implantation of fiducial markers in
or around the rectum tumor has a small risk of bleeding. The patient is
monitored for 30 minutes after implantation. Risks by elongation of the
procedure time and anaesthesia are small. The success or failure of the sensor
placement does not influence the procedure. Measurements shall only be
performed during the scheduled operation under full anaesthesia and physical
monitoring.
Collected data will not be provided to surgical physicians. Moreover, planned
surgical procedure will not be influenced by the measurements and hence patient
treatment will not be influenced by the measurements. Subjects who participate
in the study will not benefit, nor experience unacceptable additional
discomfort.
Participation in the study might involve one or two additional visits to the
hospital for the included patients for marker implantation and due to
challenging CT scheduling. The investigators will try to minimize the
additional visits and plan the scan on the same day as other appointments.
Patients will be informed for the study during the pre-operative outpatient
clinic appointment. Informed consent will be obtained before implantation of
the markers is performed. The total burden for the patient will be one
additional contrast enhanced CT scan, one or two XPerCT scans depending on the
procedure, glueing of the sensor on or near the tumour with a retractor or
proctoscope and an extension of the total surgery procedure with maximally 20
or 30 minutes depending on the amount of XperCT scans.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
* The patient is planned for rectal surgery by laparotomy or laparoscopy
* The tumour should be within 10 cm of the anal verge
* Signed informed consent
* Patients * 18 years old
Exclusion criteria
* 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL57251.031.16 |
| OMON | NL-OMON25173 |