Clinical trial NCT06793280: Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery
Official title: Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Elective Colorectal Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anastomotic Leak
Keywords: anastomotic leak
colorectal surgery
colorectal cancer
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Nuovo Ospedale dei Castelli
name: San Giovanni Addolorata Hospital
First posted: 2025-01-27
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 90 days
Secondary outcomes:
measure: Modification in the level of resection margins (cm)
timeFrame: intraoperative
measure: RCP levels (POD 3, 5)
timeFrame: 5 days
measure: Early complications (30 days)
timeFrame: 30 days
measure: Mortality
timeFrame: 90 days
measure: Hospital re-admissions
timeFrame: 30 days
measure: Operative time
timeFrame: 1 day
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Lidia Castagneto Gissey
Study officials:
References: