Determine the feasibility, safety and efficacy of electromagnetic-based image guided navigation system during soft tissue (robot assisted) laparoscopic surgery.
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Renal disorders (excl nephropathies)
Synonym
Health condition
lymfeklieren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility, safety and efficacy of the image-guided navigation system during
soft tissue surgery, first in open procedures (safety phase) and secondly in
laparoscopic and robot assisted procedures (efficacy phase).
Fefasibility will be monitord through successful implementation of the
navigation technology during laparoscopic and robot-assisted surgery.
Safety will be monitored through registration of complications during surgery
related to the use of the technology
Efficacy will be monitored throug clinical outcome parameters (I) target(s)
removed, (II) radicality of tumor removed, (III) operative morbidity and time
to regain functionality of clinically relevant indicators.
Secondary outcome
Evaluation of the total time needed to perform image guided surgery.
To be (additionally) registered en montoring times are (I) time needed to
prepare the set-up and perform CBCT-scan, (II) time needed to remove target,
(III) total operating time.
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 study is a feasibility, safety and efficacy
registration study towards clinical implementation of laparoscopic and robotic
image-guided navigation surgery.
Previous work in the Antoni van Leeuwenhoek (AvL) hospital already showed
safety and feasibility with a similar setup during open procedures. The first
phase of this study is to verify that the system and workflow will work within
the Rijnstate hospital due to differences in OR setup, workflow, hybrid OR
systems and prior experience with navigation systems. During the second phase
of this study the focus will shift from open to laparoscopic and robot assisted
laparoscopic surgery. It is the aim of the second phase to determine
feasibility, safety and efficacy of robotic image guided surgery.
Study objective
Determine the feasibility, safety and efficacy of electromagnetic-based image
guided navigation system during soft tissue (robot assisted) laparoscopic
surgery.
Study design
An feasibility, safety and efficacy pilot study. Patients are part of the study
until the end of the surgical procedure.
Study burden and risks
In the week prior to surgery, a CT-scan (radiation dose of 10 mSv) will be made
in order to create a patient specific 3D model. This model will be used to
perform the image guided surgery. Before surgery a CBCT-scan (radiation dose of
3 mSv) is performed to register the model with the patient.
This will pronlonge the total operation time, and therewith the anesthetics,
with 20 minutes on average.
This study aims to determine the accuracy and practical usability of the
navigation system in the OR and to determine the efficacy of using this
technology during robotic soft tissue surgery. The potential advantage - which
is part of the study design to be determined - is improved total removal of the
tumor and potentially affected lymph nodes.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
· Patients who are scheduled for open (phase 1) or (robot assisted)
laparoscopic (phase 2) soft tissue surgery,
· Locally advanced T3 or T4 tumor, local recurrent tumor or lymph node
metastasis,
· Patients should be suitable for contrast enhanced CT scanning,
· A signed informed consent
· Patients * 18 years old
Exclusion criteria
- patients with metal implants in the area that needs to be scanned
- patients with a pacemaker
- pregnancy
Design
Recruitment
Medical products/devices used
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 | NL73120.091.20 |