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Quantitative ICG Fluorescence Angiography in Colorectal Surgery

NCT05153954 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2024-12-03

No results posted yet for this study

Summary

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.

While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).

The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.

This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.

Conditions

Interventions

OTHER

Quantitative Indocyanine Green Fluorescence Angiography

Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Sponsors & Collaborators

  • Perfusion Tech Aps

    collaborator UNKNOWN

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Ismail Gögenur, DMSc, MD · Department of Surgery, Zealand University Hospital

  • Niclas Dohrn, MD · Department of Surgery, Herlev Hospital

  • Mads Falk Klein, PhD, MD · Department of Surgery, Herlev Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2024-08-31
Completion
2024-11-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153954 on ClinicalTrials.gov