Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

University of Roma La Sapienza

Status: Enrolling

Conditions: Anastomotic Leak

Treatments: Procedure: No intraoperative ICG angiography; Procedure: intraoperative ICG angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06793280

6608 (Other Identifier)

Details and patient eligibility

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).

Enrollment: 562 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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562 participants in 2 patient groups

ICG angiography

Experimental group

Description:

luorescence angiography is utilized to assess colonic resection margins and colorectal anastomosis, aiming to evaluate colonic blood flow. If the assessment indicates "insufficient" perfusion at the resection margin, the colon is resected once more to ensure satisfactory blood flow. luorescence angiography is utilized to assess colonic resection margins and colorectal anastomosis, aiming to evaluate colonic blood flow. If the assessment indicates "insufficient" perfusion at the resection margin, the colon is resected once more to ensure satisfactory blood flow. Colonic resection margins and colorectal anastomosis are intraoperatively assessed using fluorescence angiography to evaluate colonic perfusion. If perfusion at resection margin is considered "insufficient" the colon is resected again in order to obtain adequate perfusion.

Treatment:

Procedure: intraoperative ICG angiography

No ICG angiography

Active Comparator group

Description:

Subjective visual measures are employed by the surgeon in order to determine anastomotic perfusion.

Treatment:

Procedure: No intraoperative ICG angiography