Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06793280

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

Led by University of Roma La Sapienza · Updated on 2025-03-19

562

Participants Needed

1

Research Sites

122 weeks

Total Duration

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Sponsors

U

University of Roma La Sapienza

Lead Sponsor

N

Nuovo Ospedale dei Castelli

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Diagnosis of malignant colorectal tumors
  • Elective colorectal surgery planned
Not Eligible

You will not qualify if you...

  • History of abdomino-perineal resection
  • Emergency colorectal surgery
  • Conversion from laparoscopic to open surgery
  • No planned anastomosis during surgery
  • Multifocal colorectal tumors
  • Locally advanced cancer classified as T4
  • Presence of distant metastases (M+)
  • Major blood vessel diseases such as previous pulmonary embolism or deep vein thrombosis, or abdominal aorta surgery
  • Allergy to indocyanine green (ICG)

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Trial Site Locations

Total: 1 location

1

Lidia Castagneto Gissey

Roma, Italy, Italy, 00161

Actively Recruiting

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Research Team

L

Lidia Castagneto Gissey, MD, PhD

CONTACT

G

Giovanni Casella, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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