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

NCT07720505 | Not Yet Recruiting

• 1 other identifier: COLOFLOW
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

Keywords

colon; anastomosis; laser speckle contrast imaging; indocyanine green; ICG; Near-infrared

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural and day 0 (day of surgery)

Secondary Outcomes (3)

• Spatial Agreement

  From surgery untill 30 days follow up

• Feasibility Laser Speckle Device

  Peri-procedural (day 0)

• 30-day postoperative clinical outcomes

  Day 0 untill 30-days post operatively

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population for this study consists of adult patients undergoing elective colon or rectal resection with the creation of a primary anastomosis

You may qualify if:

• Adults ≥18 years.
• Undergoing elective colon resection with primary anastomosis.
• Able to provide consent for postoperative analysis of intraoperative imaging

You may not qualify if:

• Palliative surgery.
• Factors that severely limit intraoperative visualization (per investigator judgement).
• Conditions interfering with perfusion assessment (e.g., severe peripheral vascular compromise).

Sponsors & Collaborators

• Leiden University Medical Center: lead

Related Publications (3)

• Wildeboer 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 BACKGROUND

• Heeman 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 BACKGROUND

• De 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 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak; Colonic Neoplasms; Rectal Neoplasms; Rectal Diseases

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Indy Planting, MD

CONTACT

+31614524783; i.planting@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07