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ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leak After Elective Laparoscopic Colorectal Resection: A Prospective Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07826156
Enrollment
120
Registered
2026-09-17
Start date
2025-08-02
Completion date
2026-09-09
Last updated
2026-09-17

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

Conditions

Colorectal Anastomotic Leak, Colorectal Disease Requiring Elective Laparoscopic Resection

Keywords

Indocyanine green, ICG fluorescence angiography, near-infrared imaging, bowel perfusion, colorectal surgery, laparoscopic colorectal resection, colorectal anastomosis, anastomotic leakage

Brief summary

This prospective randomized controlled trial evaluates whether intraoperative indocyanine green (ICG) fluorescence angiography reduces clinically significant anastomotic leakage after elective laparoscopic colorectal resection with primary anastomosis. A total of 120 adults were allocated in a 1:1 ratio to ICG-guided perfusion assessment or standard visual perfusion assessment, with 60 participants in each group. In the ICG arm, ICG 0.2 mg/kg was administered intravenously after bowel mobilization and before transection, and near-infrared imaging guided selection of a well-perfused transection margin. Participants were followed for 90 days after surgery for grade B or C anastomotic leakage.

Detailed description

Adequate perfusion is essential for colorectal anastomotic healing. Standard intraoperative assessment relies on bowel color, mesenteric pulsation, and bleeding from the cut edge. ICG fluorescence angiography provides real-time near-infrared visualization of bowel perfusion and may identify inadequately perfused segments before anastomosis. Eligible participants undergoing elective laparoscopic colorectal resection with planned primary anastomosis were randomized using closed-envelope allocation. In the experimental arm, fluorescence was evaluated using a standardized ordinal score: 0, no fluorescence within 60 seconds; 1, delayed or patchy fluorescence at 60 seconds; 2, reduced but homogeneous fluorescence within 30-60 seconds; and 3, rapid homogeneous fluorescence within 30 seconds. Time to fluorescence was recorded at a defined region of interest, and transection was performed at an area showing grade 3 perfusion. In the comparator arm, transection and anastomosis proceeded using standard visual assessment without ICG. Postoperative evaluation included clinical surveillance. Contrast-enhanced computed tomography of the abdomen and pelvis was obtained when clinically indicated. Clinically significant anastomotic leakage was defined as grade B or C leakage within 90 days and confirmed by clinical findings, contrast imaging, or reoperation.

Interventions

Visual assessment

DIAGNOSTIC_TESTICG visuals assessment

Injection of ICG and visually asses vascularity

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

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

Inclusion criteria

* Adults aged 18 years or older. * Undergoing elective laparoscopic colorectal resection. * Planned primary colorectal anastomosis. * Able and willing to provide written informed consent.

Exclusion criteria

* Known allergy to iodine or indocyanine green. * Severe hepatic dysfunction. * Severe renal dysfunction. * Emergency colorectal resection. * Inflammatory bowel disease requiring extensive resection. * Previous colorectal surgery involving the planned anastomotic site.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of clinically significant anastomotic leakage90 days after surgeryIncidence of clinically significant anastomotic leakage, defined as Grade B or Grade C leak, .

Secondary

MeasureTime frameDescription
Change in the planned bowel transection margin after ICG assessmentOne hour intraoperativeChange in the planned bowel transection margin after ICG assessment
Operative timeHours in the operative theaterOperative time taken from skin to skin
ICG-related adverse reactions, such as hypotension or allergic reaction4 Hours intraoperativeICG-related adverse reactions, such as hypotension or allergic reaction

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORIbrahim Magdy Ibrahim G. Ghallab

ALEXANDRIA UNIVERSITY FACULTY OF MEDICINE

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026