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

Sponsor
Leiden University Medical Center
Study ID
NCT07720505
Status
Not Yet Recruiting

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Conditions

  • Colon Anastomosis
  • Colon Benign Tumor
  • Colon Cancer
  • Colon and Rectal Cancer
  • Colon and Rectal Diseases
  • Indocyanine Green (ICG)
  • Laser Speckle Contrast Imaging
  • Leakage, Anastomotic
  • Near-Infrared Spectroscopy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laser Speckle Contrast Imaging — DIAGNOSTIC_TEST
    Standard-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.

Study Details

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

Key Dates

First listed
Jul 22, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Agreement ICG vs LSCI [ Time Frame: Periprocedural and day 0 (day of surgery) ]

Central Contacts

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