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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06793280
Enrollment
562
Registered
2025-01-27
Start date
2022-02-22
Completion date
2026-03-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Keywords

anastomotic leak, colorectal surgery, colorectal cancer

Brief 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).

Interventions

PROCEDUREintraoperative ICG angiography

Intraoperative ICG angiography to evaluate colonic perfusion

PROCEDURENo intraoperative ICG angiography

Visual evaluation of colonic perfusion

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER
Nuovo Ospedale dei Castelli
CollaboratorUNKNOWN
San Giovanni Addolorata Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

An interim analysis incoroporating a futility assessment is designed to assess whether this trial is likely to meet its objective before its completion

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Anastomotic leak rate90 days

Secondary

MeasureTime frame
Modification in the level of resection margins (cm)intraoperative
RCP levels (POD 3, 5)5 days
Early complications (30 days)30 days
Mortality90 days
Hospital re-admissions30 days
Operative time1 day

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026