ClinicalTrials.gg
CompletedNCT07826156Updated Sep 17, 2026

ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection

An interventional study of Visual assessment and ICG visuals assessment in Colorectal Disease Requiring Elective Laparoscopic Resection and Colorectal Anastomotic Leak, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Alexandria University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Aug 2025, registered Sep 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Anastomotic Leak with a site in Egypt — 4 open to participants now, 4 under way, none of them phase 3. Anastomotic Leak · Egypt.

Enrollment
2nd of 10
120 · median 85
Started
2025
with 3 others
No phase
7 of 13
1 open now
Registered
13th of 13
by date
Lead sponsor
3 of 13
Alexandria University

Among the 13 studies in Anastomotic Leak with a site in Egypt, this one is the 2nd largest by enrollment of the 10 interventional ones that give a count, is one of 4 that started in 2025, is one of 7 with no phase, and was the 13th registered.

Anastomotic Leak

240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.

Browse Anastomotic Leak studies →

Open to participants now

4 of the 13 studies in Anastomotic Leak with a site in Egypt are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 45 Anastomotic Leak studies recruiting now, 23 (51%) set no upper age limit and 11 (24%) stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Anastomotic Leak with a site in Egypt, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Colorectal Disease Requiring Elective Laparoscopic Resection
  • Colorectal Anastomotic Leak

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Keywords

  • Indocyanine green
  • ICG fluorescence angiography
  • near-infrared imaging
  • bowel perfusion
  • colorectal surgery
  • laparoscopic colorectal resection
  • colorectal anastomosis
  • anastomotic leakage
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    ICG Fluorescence Angiography

    Assess the blood supply using icg

    Other: Visual assessment

  • Active comparator
    Standard Visual Perfusion Assessment

    Immediate visual assessment for colon blood supply

    Diagnostic Test: ICG visuals assessment

Interventions

  • OtherVisual assessment

    Visual assessment

  • Diagnostic testICG visuals assessment

    Injection of ICG and visually asses vascularity

06

What researchers measure

Primary outcomes

  1. Incidence of clinically significant anastomotic leakage

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

    Time frame: 90 days after surgery

Secondary outcomes

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

    Change in the planned bowel transection margin after ICG assessment

    Time frame: One hour intraoperative

  2. Operative time

    Operative time taken from skin to skin

    Time frame: Hours in the operative theater

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

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

    Time frame: 4 Hours intraoperative

07

Study locations

1 site
  • Alexandria Main University Hospital
    Alexandria, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2025 to primary completion in Sep 2026, 13 months.

Of 58 non-industry interventional studies with no phase under Anastomotic Leak, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 13 months is below that.

Counting every sponsor, half of 65 studies reached it within 32 months; a quarter within 19 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2026
First posted
Sep 17, 2026
StartActual
Aug 2, 2025
Primary completionActual
Sep 4, 2026
CompletionActual
Sep 9, 2026
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07826156
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Aug 2, 2025
Primary completion
Sep 4, 2026
Completion
Sep 9, 2026
Last update
Sep 17, 2026

Study contacts

Ibrahim Magdy Ibrahim G. Ghallab
principal investigator · ALEXANDRIA UNIVERSITY FACULTY OF MEDICINE

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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