COLOFLOW is a prospective observational study investigating whether Laser Speckle Contrast Imaging (LSCI), a dye-free and objective perfusion imaging technique, corresponds with the currently used subjective assessment of indocyanine green (ICG) fluorescence during colorectal surgery. In approximately 30 patients undergoing elective colon or rectal resection with primary anastomosis, both imaging modalities will be performed intraoperatively. The surgeons will base their clinical decisions solely on standard ICG fluorescence imaging, while LSCI measurements are collected for research purposes and do not influence treatment. Postoperatively, quantitative ICG parameters will be analysed and compared with LSCI perfusion maps to determine whether objective ICG analysis improves agreement with LSCI over subjective interpretation alone. In addition, the study will evaluate the feasibility of using the PerfusiX-IGS LSCI system during open colorectal surgery and describe postoperative outcomes, including anastomotic leakage. The ultimate goal is to contribute to more objective and standardized perfusion assessment during colorectal surgery
Adults ≥18 years.
Undergoing elective colon resection with primary anastomosis.
Able to provide consent for postoperative analysis of intraoperative imaging
Palliative surgery.
Factors that severely limit intraoperative visualization (per investigator judgement).
The population for this study consists of adult patients undergoing elective colon or rectal resection with the creation of a primary anastomosis
Cohort
Prospective
Laser Speckle Contrast Imaging
Diagnostic testStandard-of-care ICG fluorescence angiography for assessment of bowel perfusion and observational intraoperative Laser Speckle Contrast Imaging (LSCI) using the PerfusiX-IGS system. LSCI measurements do not influence surgical decision-making and are performed solely for comparison with subjective and quantitative ICG perfusion assessment.
Agreement ICG vs LSCI
the agreement between subjective ICG fluorescence assessment and LSCI perfusion imaging at the planned anastomotic site during colorectal surgery. This agreement will be evaluated in two ways: (1) categorical agreement, determining whether both techniques classify perfusion as adequate or inadequate, and (2) spatial agreement, assessing how closely the perfusion boundary identified by the surgeon using ICG corresponds to the perfusion boundary detected by LSCI.
Spatial Agreement
Spatial distance (in millimetres) between the quantitative ICG perfusion boundary and the LSCI perfusion boundary
Feasibility Laser Speckle Device
the feasibility and usability of the PerfusiX-IGS LSCI system Unit of Measure: Successful acquisitions (%) Acquisition time (seconds) Technical failures (%)
30-day postoperative clinical outcomes
Clinical outcomes and the occurrence of anastomotic leakage. The proportion of patients experiencing any complication and the distribution of Clavien-Dindo grades will be recorded. Incidence of anastomotic leakage within 30 days after surgery, defined according to standard clinical and/or radiological criteria as applied in routine clinical practice. The proportion of patients diagnosed with anastomotic leakage will be recorded.
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