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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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

Eligibility criteria

Qualifiers

Adults ≥18 years.

Undergoing elective colon resection with primary anastomosis.

Able to provide consent for postoperative analysis of intraoperative imaging

Disqualifiers

Palliative surgery.

Factors that severely limit intraoperative visualization (per investigator judgement).

Trial design

Treatments tested in this trial

  • Laser Speckle Contrast Imaging

Treatment groups

No treatment groups listed

Locations

This trial has no locations