An observational study in Leakage, Anastomotic, Colon Cancer and Colon Anastomosis, sponsored by Leiden University Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Leiden University Medical Center · Observational
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
Study Title: COLOFLOW: Quantified ICG Fluorescence versus Laser Speckle Contrast Imaging (LSCI) for Perfusion Assessment in Colorectal Surgery.
Background Anastomotic leakage is a serious complication after colorectal surgery, occurring in approximately 10-15% of patients and contributing substantially to postoperative morbidity and mortality. Surgeons increasingly use indocyanine green (ICG) fluorescence imaging to assess bowel perfusion during surgery, but interpretation remains largely subjective and the technique has limitations, including dye dependency and difficulties with repeated measurements. Laser Speckle Contrast Imaging (LSCI) is a dye-free, real-time imaging technique that provides objective perfusion maps and may overcome several of these limitations.
Aim The primary aim of the study is to determine how well subjective intraoperative ICG fluorescence assessment agrees with LSCI perfusion imaging when evaluating bowel perfusion at the planned anastomotic site during colorectal surgery.
Secondary aims are:
To evaluate the spatial agreement between postoperative quantitative ICG analysis and LSCI perfusion boundaries.
To assess the feasibility of using the PerfusiX-IGS LSCI system during open colorectal surgery.
To record clinical outcomes, including anastomotic leakage rates.
Study Design COLOFLOW is a prospective, single-centre, observational study conducted at the Leiden University Medical Centre (LUMC). No randomization, blinding, or intervention is performed. LSCI measurements are recorded for research purposes only and do not influence surgical decision-making.
Participants The study includes approximately 30 adult patients undergoing elective colon or rectal resection with creation of a primary anastomosis. This population corresponds to patients enrolled in the ongoing QUANTICOLON study.
Inclusion Criteria
Age ≥18 years. Elective colorectal resection with primary anastomosis. Ability to provide informed consent.
Exclusion Criteria
Palliative surgery. Poor intraoperative visualization. Conditions that substantially interfere with perfusion assessment.
Methods
During surgery:
The surgeon identifies the planned bowel transection site under white light. The bowel is exteriorized for imaging. The PerfusiX-IGS LSCI system records a perfusion map. Standard-of-care ICG fluorescence imaging is then performed and interpreted subjectively by the surgeon.
After surgery, ICG recordings are quantitatively analysed using dedicated software to derive perfusion parameters such as:
Time to fluorescence onset (T0) Time to peak intensity (Tmax) Maximum intensity (Imax) Maximum normalized slope Outflow area-under-the-curve measurements
A custom Python-based analysis is used to compare the location of perfusion boundaries identified by both imaging techniques.
Outcomes Primary Endpoint
Agreement between subjective ICG interpretation and LSCI perfusion mapping, assessed by:
Categorical agreement (adequate vs. inadequate perfusion). Spatial agreement between perfusion boundaries identified by both modalities.
Secondary Endpoints
Distance between quantitative ICG and LSCI perfusion boundaries. Feasibility and usability of the PerfusiX-IGS system. Success rate of obtaining calibrated image documentation. Thirty-day postoperative outcomes, including complications and anastomotic leakage.
Statistical Analysis Categorical agreement will be evaluated using Cohen's kappa coefficient, while spatial agreement will be assessed with Bland-Altman analysis. Secondary analyses will explore whether quantitative ICG measurements provide better agreement with LSCI than subjective assessment alone.
Ethical Considerations The study is classified as non-WMO (non-Medical Research Involving Human Subjects Act) because it introduces no intervention beyond standard care. LSCI is non-contact, non-invasive, and does not influence treatment decisions. Risks to participants are minimal and primarily related to the storage and handling of anonymized imaging data.
Conclusion COLOFLOW investigates whether objective, dye-free LSCI can serve as a reliable reference method for bowel perfusion assessment during colorectal surgery and whether postoperative quantitative analysis of ICG fluorescence can improve upon the current subjective interpretation of ICG imaging. The study aims to support the development of more standardized and objective perfusion assessment strategies that may ultimately help reduce anastomotic leakage.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
This study's planned enrollment of 30 is below the median of 166 across 111 observational studies indexed under Anastomotic Leak.
Browse Anastomotic Leak studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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The population for this study consists of adult patients undergoing elective colon or rectal resection with the creation of a primary anastomosis
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Exclusion Criteria:
Conditions interfering with perfusion assessment (e.g., severe peripheral vascular compromise).
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.
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.
Time frame: Periprocedural and day 0 (day of surgery)
Spatial Agreement
Spatial distance (in millimetres) between the quantitative ICG perfusion boundary and the LSCI perfusion boundary
Time frame: From surgery untill 30 days follow up
Feasibility Laser Speckle Device
the feasibility and usability of the PerfusiX-IGS LSCI system Unit of Measure: Successful acquisitions (%) Acquisition time (seconds) Technical failures (%)
Time frame: Peri-procedural (day 0)
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.
Time frame: Day 0 untill 30-days post operatively
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 50 non-industry observational studies under Anastomotic Leak, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 73. This study's planned 12 months is below that.
Counting every sponsor, half of 52 studies reached it within 33 months; a quarter within 23 and three quarters within 98.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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