This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
Investigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg/kg, Firefly® fluorescence imaging PerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation. Diagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema.
Regional Hospital Gødstrup
Herning, Denmark
Sygehus Lillebælt, Vejle Hospital
Vejle, Denmark
Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation. Unit: Percentage of participants with succesful assessment
Time frame: Intraoperatively
Surgeon-reported acceptability of PerfusiX-Imaging
Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if \>80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. Unit: Percentage of surgeons with a positive evaluation
Time frame: intraoperatively
Potential impact of PerfusiX-Imaging on surgical decision making
The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm. Unit: milimetres (mm)
Time frame: Intraoperatively
Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI
Surgeons will assess the acceptability and performance of PerfusiX-Imaging and ICG-FI using a predefined Likert-scale questionnaire. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. The proportion of surgeons providing a positive evaluation of PerfusiX-Imaging will be compared with the proportion providing a positive evaluation on ICG-FI. Unit of measure: Proportion of surgeons
Time frame: Immediately after surgery
Absolute intestinal microcirculation
Intestinal microcirculation will be quantified using laser speckle contrast imaging (LSCI). Absolute microcirculation will be expressed as the mean laser speckle perfusion unit (LSPU) value obtained from a predefined region of interest (ROI) close to the intestinal anastomotic line. Unit of measure: Laser speckle perfusion units, LSPU
Time frame: Intraoperatively
Relative intestinal microcirculation
Relative intestinal microcirculation will be calculated by normalizing the mean LSPU value from a region of interest to the mean LSPU value obtained from a reference region on the intestines: Unit of measure: Percentage (%): measurement/control\*100
Time frame: Intraoperatively
Length of initial hospital stay after surgery
Length of initial hospital stay after surgery will be calculated as the number of hours from the end of surgery until initial discharge from hospital. The association between length of initial hospital stay after surgery and quantitative measurements of intestinal microcirculation will be explored. Unit of measure: Hours
Time frame: From the end of surgery until initial hospital discharge, up to 30 days after surgery
Severity of postoperative complications according to the Clavien-Dindo classification
Postoperative complications occuring within 30 days after surgery will be graded according to the Clavien-Dindo classification (Grade I-V). The asociation between quatitative measurements of intestinal microcirculation and the severity of postoperative complications will be explored. Units of measure: Clavien-Dindo
Time frame: 30 days after surgery
Surgical complications within 30 days after surgery
The occurence of surgical complications within 30 days after surgery will be recorded. Surgical complications include bleeding, fascial dehiscence, postoperative ileus, surgical site infection, intraabdominal abscess, stoma related complications. The association between surgical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored. Units of measure: Participants with one or more surgical complications
Time frame: 30 days after surgery
Medical complications within 30 days after surgery
The occurence of medical complications within 30 days after surgery will be recorded. Medical complicatinos include stroke, myocardial infarction, heart failure, pneumonia, aspiration, respiratory failure, deep vein thrombosis, acute arterial insufficiency and sepsis. The association between medical complications within 30 days after surgery and quantitative measurements of intestinal microcirculation will be explored Units of measure: Participants with one or more medical complications
Time frame: 30 days after surgery
Anastomotic leakage within 30 days of surgery
Occurrence of anastomotic leakage within 30 days after surgery will be recorded as a binary outcome (yes/no). The association between anastomotic leakage and quantitative measurements of intestinal microcirculation will be explored. Units of measure: Participants with anastomotic leakage
Time frame: 30 days after surgery
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