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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Italy
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Roma, Italy, Italy, 00161
- Lidia Castagneto Gissey
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ICG angiography
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. |
Intraoperative ICG angiography to evaluate colonic perfusion
|
|
Active Comparator: No ICG angiography
Subjective visual measures are employed by the surgeon in order to determine anastomotic perfusion.
|
Visual evaluation of colonic perfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anastomotic leak rate
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality
Time Frame: 90 days
|
90 days
|
|
Operative time
Time Frame: 1 day
|
1 day
|
|
Modification in the level of resection margins (cm)
Time Frame: intraoperative
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intraoperative
|
|
RCP levels (POD 3, 5)
Time Frame: 5 days
|
5 days
|
|
Early complications (30 days)
Time Frame: 30 days
|
30 days
|
|
Hospital re-admissions
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Postoperative Complications
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Anastomotic Leak
Other Study ID Numbers
- 6608 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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