The overall objective of this study is to determine whether the use of additional Lapvas-imaging derived visual feedback might influence the choice of surgeons for the optimal location of the anastomosis.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The percentage of operating surgeons that indicated no change in location of
the anastomosis based on the additional Lapvas-Imaging derived visual feedback;
- The percentage of the non-involved surgeons that indicated no change in
location of the anastomosis based on the additional Lapvas-Imaging derived
visual feedback;
- The proportion of the indication of a change in location by operating and
non-involved surgeons between patients with and without AL;
- The homogeneity of the change in location between non-involved surgeons for
individual patients;
- The estimated change in location of the anastomosis proximal/distal in
centimeters by the treating surgeon;
- The estimated change in location of the anastomosis proximal/distal in
centimeters by non-involved surgeons;A change in the location of the
anastomosis by non-involved surgeons in comparison to the operating surgeon);
- Development of anastomotic leakage;
- Extra time taken for imaging during surgery (seconds);
Secondary outcome
N/A
Background summary
For colorectal cancer, the third most commonly occurring malignancy worldwide,
surgery remains the primary therapeutic modality. However, anastomotic leakage
(AL) is a major problem in gastrointestinal surgery A recent large Dutch cohort
study reported an AL incidence of 8.4%. The persistence of this complication
over the last decades is partly caused by its multi-factorial origin. The
general consensus is that an important factor regarding AL is the state of
microcirculation at the site of the anastomosis. It is expected that a better
state of microcirculation contributes to a fast healing process which in term
leads to a lower incidence of AL. Lapvas-Imaging is contactless, dye-free real
time perfusion imaging tool that gives insight in the state of perfusion of
live tissue during laparoscopic surgery. The investigation medical device is
based on a technique called laser speckle contrast imaging (LSCI). It uses the
current standard of care laparoscopic video equipment.
Study objective
The overall objective of this study is to determine whether the use of
additional Lapvas-imaging derived visual feedback might influence the choice of
surgeons for the optimal location of the anastomosis.
Study design
The current study is a prospective, observational study. A total of 67
patients undergoing an oncological colorectal resection will be included.
2D-perfusion maps will be generated from images taken with Lapvas-Imaging
(LIMIS Development BV, Leeuwarden, The Netherlands) in combination with a
standard surgical laparoscope and video system (EndoEye, Olympus Medical,
Hamburg, Germany) during surgery at the moment before the creation of the
proximal and distal anastomosis. The images will be shown to the surgeon
postoperatively.
Study burden and risks
Time during surgery: The surgery will take up around 2 minutes more. There are
no known risks to study participants. Patients will have no benefit from this
study directly. Surgery will be planned as usual. During surgery, no decisions
will be made based on Lapvas-Imaging.
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Confirmed diagnosis of colorectal cancer and are scheduled to undergo surgical
resection (Hemicolectomy right, hemicolectomy left and sigmoid resection)
Exclusion criteria
Subtotal colectomy, abdominoperineal resection, temporary colostomy procedures,
septic patients, non-elective surgery
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 | NL74681.099.20 |