No registrations found.
ID
Source
Brief title
Health condition
Colorectal cancer
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
NA
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. 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 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 objective
the current intraoperative selection of an optimal site for the anastomosis is based on subjective clinical indicators of intestinal viability. As indicated by others there is a need for a gold standard in determining the state of microcirculation of the intestines. This method should be suitable for laparoscopic use, robust and preferably non-invasive. Using Lapvas-Imaging, real-time feedback can be obtained and used for clinical decision-making during surgery, which might be beneficial to the patient. In this prospective observational feasibility study, we aim to determine whether surgeons would choose a different location for the original anastomosis, based on additional Lapvas-imaging derived visual feedback
Study design
Images will be acquired during surgery using Lapvas-Imaging before the surgeon dissects the (1) proximal and (2) distal end of the anastomosis. The surgeons will subsequently be questioned using these images.
Inclusion criteria
In order to be eligible to participate in this study, the subject must meet all following criteria:
- Confirmed colorectal cancer and scheduled to undergo surgical resection;
- Age > 18 years;
- Written informed consent;
Exclusion criteria
- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent;
- Concurrent uncontrolled medical conditions;
- Elected for subtotal colectomy;
- Elected for abdominoperineal resection;
- Elected for temporary colostomy procedures;
- Septic patients;
- Non-elective surgery;
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 | NL9215 |
Other | RTPO : RTPO1102 |