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OpenTrials
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NCT Number: NCT06793280

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

Despite advancements in technology and improved surgical techniques, the occurrence of anastomotic leakage (AL) after colorectal surgery remains between 4% and 30%. AL is a feared complication associated with significant morbidity and mortality in colorectal surgery, with its causes being multifaceted. Inadequate blood supply to the intestines is believed to be a major contributor to its development. Various methods have been proposed to objectively assess intestinal perfusion beyond the subjective evaluation done by surgeons during surgery. However, these methods face challenges such as poor reproducibility and high costs, limiting their routine use. In recent years, indocyanine green (ICG) angiography has emerged as a tool for assessing organ perfusion in various medical scenarios. However, only one randomized clinical trial has been conducted regarding its use in evaluating colorectal surgery outcomes, which found that while ICG angiography sometimes led to additional bowel resection, it didn't significantly reduce the rate of anastomotic leaks compared to conventional methods. This could be due to the trial's small sample size, potentially reducing its statistical power. This study aims to investigate whether ICG angiography can lower the rate of anastomotic leaks during laparoscopic colorectal cancer surgery, while also examining its impact on resection margins, perioperative morbidity, and mortality rates.

A total of 561 subjects undergoing laparoscopic colorectal surgery for malignancy, will be randomized in 2 arms: A Study Group undergoing ICG angiography (i.e. colonic perfusion is intraoperatively assessed by ICG angiography and level of resection is selected based on the fluorescence) and a Control Group (i.e. resection is performed based on subjective judgment).

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-85 years
  • Malignant colorectal tumors
  • Elective surgery

Exclusion criteria

  • Abdomino-perineal resection
  • Emergency procedures
  • Conversion to open surgery
  • No anastomosis
  • Multifocal tumors
  • Locally advanced cancer (T4)
  • Distant metastases (M+)
  • Major vasculopathies (previous PE, DVT, abdominal aorta surgery)
  • ICG allergy

Treatment and study plan

intraoperative ICG angiography

Procedure

Intraoperative ICG angiography to evaluate colonic perfusion

No intraoperative ICG angiography

Procedure

Visual evaluation of colonic perfusion

Primary outcomes

  1. Anastomotic leak rate

    Time frame: 90 days

Secondary outcomes

  1. Modification in the level of resection margins (cm)

    Time frame: intraoperative

  2. RCP levels (POD 3, 5)

    Time frame: 5 days

  3. Early complications (30 days)

    Time frame: 30 days

  4. Mortality

    Time frame: 90 days

  5. Hospital re-admissions

    Time frame: 30 days

  6. Operative time

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Nuovo Ospedale dei Castelli
  • San Giovanni Addolorata Hospital

Registry information

Official study title

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Elective Colorectal Surgery: Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
May 20, 2026

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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