Feasibility of laser speckle contrast imaging using the bowel perfusion assessment tool Lapvas-Imaging
- Conditions
- Colorectal cancer
- Registration Number
- NL-OMON25695
- Lead Sponsor
- IMIS Development B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 67
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;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -The percentage of operating surgeons that indicated no change in location of the anastomosis based on the additional Lapvas-Imaging derived visual feedback;<br>-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; <br>-The proportion of the indication of a change in location by operating and non-involved surgeons between patients with and without AL; <br>-The homogeneity of the change in location between non-involved surgeons for individual patients;<br>-The estimated change in location of the anastomosis proximal/distal in centimeters by the treating surgeon;<br>-The estimated change in location of the anastomosis proximal/distal in centimeters by non-involved surgeons;<br>-A change in the location of the anastomosis by non-involved surgeons in comparison to the operating surgeon;<br>-Development of anastomotic leakage;<br>-Extra time taken for imaging during surgery (seconds);
- Secondary Outcome Measures
Name Time Method