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.
Age ≥ 18 years
Rectal cancer
Surgical strategy either partial or total mesorectal excision
Able to provide informed consent
None
Single group
Laser speckle contrast imaging
DeviceInvestigated 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.
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
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
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)
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
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
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
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
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