Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging

Condition(s) studied

Investigational drug(s) / intervention(s)

Laser speckle contrast imaging: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging — Intraoperatively
  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 — intraoperatively
  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 — Intraoperatively
  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)

Trial sites (2)

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