Clinical trial · Observational
COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Anastomosis | — | UNRESOLVED | — |
| Colon and Rectal Cancer | — | UNRESOLVED | — |
| Colon and Rectal Diseases | — | UNRESOLVED | — |
| Colon Benign Tumor | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Laser Speckle Contrast Imaging | — | UNRESOLVED | — |
| Leakage, Anastomotic | — | UNRESOLVED | — |
| Near-Infrared Spectroscopy | — | UNRESOLVED |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser Speckle Contrast Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Agreement ICG vs LSCI
- timeFrame
- Periprocedural and day 0 (day of surgery)
- description
- 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.
Secondary outcomes (3)
- measure
- Spatial Agreement
- timeFrame
- From surgery untill 30 days follow up
- description
- Spatial distance (in millimetres) between the quantitative ICG perfusion boundary and the LSCI perfusion boundary
- measure
- Feasibility Laser Speckle Device
- timeFrame
- Peri-procedural (day 0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥18 years. * Undergoing elective colon resection with primary anastomosis. * Able to provide consent for postoperative analysis of intraoperative imaging Exclusion Criteria: * Palliative surgery. * Factors that severely limit intraoperative visualization (per investigator judgement). Conditions interfering with perfusion assessment (e.g., severe peripheral vascular compromise).
References
Publications (3)
- BACKGROUNDWildeboer A, Heeman W, van der Bilt A, Hoff C, Calon J, Boerma EC, Al-Taher M, Bouvy N. Laparoscopic Laser Speckle Contrast Imaging Can Visualize Anastomotic Perfusion: A Demonstration in a Porcine Model. Life (Basel). 2022 Aug 16;12(8):1251. doi: 10.3390/life12081251. PMID 36013430
- BACKGROUNDHeeman W, Wildeboer ACL, Al-Taher M, Calon JEM, Stassen LPS, Diana M, Derikx JPM, van Dam GM, Boerma EC, Bouvy ND. Experimental evaluation of laparoscopic laser speckle contrast imaging to visualize perfusion deficits during intestinal surgery. Surg Endosc. 2023 Feb;37(2):950-957. doi: 10.1007/s00464-022-09536-9. Epub 2022 Sep 6. PMID 36068388
- BACKGROUNDDe Nardi P, Elmore U, Maggi G, Maggiore R, Boni L, Cassinotti E, Fumagalli U, Gardani M, De Pascale S, Parise P, Vignali A, Rosati R. Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc. 2020 Jan;34(1):53-60. doi: 10.1007/s00464-019-06730-0. Epub 2019 Mar 21. PMID 30903276