Clinical Trial

COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green

Study acronym: COLOFLOW
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07720505
Lead Sponsor Leiden University Medical Center
Conditions Leakage, Anastomotic, Colon Cancer, Colon Anastomosis, Colon and Rectal Cancer, Colon Benign Tumor, Colon and Rectal Diseases, Laser Speckle Contrast Imaging, Indocyanine Green (ICG) +1 more
Enrollment 30 participants
Start Date 2026-08-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22