RecruitingNot ApplicableNCT06793280

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

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


Sponsor

University of Roma La Sapienza

Enrollment

562 participants

Start Date

May 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a technique called indocyanine green (ICG) angiography — where a special dye is injected to visualize blood flow — during colorectal cancer surgery. The goal is to check if the remaining part of the colon has enough blood supply after a section is removed, which helps reduce the risk of leaks at the reconnection site. **You may be eligible if...** - You are 18–85 years old with colorectal cancer - You are scheduled for planned (non-emergency) colorectal surgery **You may NOT be eligible if...** - You need emergency surgery - Your surgery requires complete removal of the rectum without reconnection - Your cancer has spread to distant organs - You have a known allergy to ICG dye or serious blood vessel disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREintraoperative ICG angiography

Intraoperative ICG angiography to evaluate colonic perfusion

PROCEDURENo intraoperative ICG angiography

Visual evaluation of colonic perfusion


Locations(1)

Lidia Castagneto Gissey

Roma, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06793280


Related Trials