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Completed

NCT Number: NCT05153954

Quantitative ICG Fluorescence Angiography in Colorectal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Zealand University Hospital, Køge, Region Sjælland, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Capable of giving informed consent
  • ASA Classification: status I-III
  • Planned for PME or TME with minimally invasive approach and primary anastomosis
  • Strong suspicion of or biopsy-verified sigmoid or rectal cancer Stage I-IV cancer

Exclusion criteria

  • Known allergy to ICG or iodine
  • Emergency procedure
  • Pregnancy or if the patient is currently nursing
  • Surgeons decide to do unblinded quantitative or qualitative ICG-FA

Treatment and study plan

Quantitative Indocyanine Green Fluorescence Angiography

Other

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

Primary outcomes

  1. Postoperative anastomotic complications

    Time frame: 3 months

    combined rate of all anastomotic complications

Secondary outcomes

  1. Number of participants with complications according to Clavien-Dindo Classification

    Time frame: 90 days

  2. Number of participants with anastomotic leakage rate, severity (grade A-C)

    Time frame: 90 days

  3. Number of participants with postoperative bleeding

    Time frame: 10 days

  4. Number of participants with postoperative paralytic ileus

    Time frame: 90 days

    obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery

  5. Number of participants with wound dehiscence

    Time frame: 1 month

    surgical complication in which a wound ruptures along a surgical incision

  6. Comprehensive complications index

    Time frame: 90 days

  7. Duration of surgery

    Time frame: 1 day

  8. Reoperation rate

    Time frame: 1 month

  9. Hospital readmission

    Time frame: 1 month

    Number of patients had have to be readmitted to the hospital due to postoperative complications

  10. Length of hospital stay

    Time frame: 1 month

  11. QT interval variability

    Time frame: 2 days

    Continuous ECG-monitoring intraoperatively and postoperatively

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Perfusion Tech Aps

Registry information

Official study title

Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): a Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial

Acronym: QUANTICO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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