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OpenTrials
Completed

NCT Number: NCT07826156

ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Main University Hospital

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visual Assessment

Other

Visual assessment

ICG visuals assessment

Diagnostic Test

Injection of ICG and visually asses vascularity

Primary outcomes

  1. Incidence of clinically significant anastomotic leakage

    Time frame: 90 days after surgery

    Incidence of clinically significant anastomotic leakage, defined as Grade B or Grade C leak, .

Secondary outcomes

  1. Change in the planned bowel transection margin after ICG assessment

    Time frame: One hour intraoperative

    Change in the planned bowel transection margin after ICG assessment

  2. Operative time

    Time frame: Hours in the operative theater

    Operative time taken from skin to skin

  3. ICG-related adverse reactions, such as hypotension or allergic reaction

    Time frame: 4 Hours intraoperative

    ICG-related adverse reactions, such as hypotension or allergic reaction

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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