Colorectal Disease Requiring Elective Laparoscopic ResectionNCT07826156
ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection
A study testing Visual assessment and ICG visuals assessment in people with Colorectal Disease Requiring Elective Laparoscopic Resection and Colorectal Anastomotic Leak, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disease Requiring Elective Laparoscopic Resection, Colorectal Anastomotic Leak
- What is being tested?
- Visual assessment and ICG visuals assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2025to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Undergoing elective laparoscopic colorectal resection.
- Planned primary colorectal anastomosis.
- Able and willing to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leak After Elective Laparoscopic Colorectal Resection: A Prospective Randomized Controlled Trial
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.
- Being tested
- Visual assessment, ICG visuals assessment
- Keywords
- Indocyanine green, ICG fluorescence angiography, near-infrared imaging, bowel perfusion, colorectal surgery, laparoscopic colorectal resection, colorectal anastomosis, anastomotic leakage
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual assessmentOther
Visual assessment
ICG visuals assessmentDiagnostic test
Injection of ICG and visually asses vascularity
| Study group | Role | What they receive |
|---|---|---|
| ICG Fluorescence Angiography | Experimental | Assess the blood supply using icg Receives: Other: Visual assessment |
| Standard Visual Perfusion Assessment | Active comparator | Immediate visual assessment for colon blood supply Receives: Diagnostic Test: ICG visuals assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant anastomotic leakage
Incidence of clinically significant anastomotic leakage, defined as Grade B or Grade C leak, .
Measured: 90 days after surgery
Secondary outcomes (3)
Change in the planned bowel transection margin after ICG assessment
Change in the planned bowel transection margin after ICG assessment
Measured: One hour intraoperative
Operative time
Operative time taken from skin to skin
Measured: Hours in the operative theater
ICG-related adverse reactions, such as hypotension or allergic reaction
ICG-related adverse reactions, such as hypotension or allergic reaction
Measured: 4 Hours intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start2 Aug 2025
- Primary completion4 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Disease Requiring Elective Laparoscopic ResectionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ibrahim Magdy Ibrahim G. Ghallab, Principal investigator, ALEXANDRIA UNIVERSITY FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826156
- Sponsor's protocol ID
- 0202285
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leak After Elective Laparoscopic Colorectal Resection: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07826156
- Acronym / sponsor ID
- 0202285
- Keywords
- Indocyanine green, ICG fluorescence angiography, near-infrared imaging, bowel perfusion, colorectal surgery, laparoscopic colorectal resection, colorectal anastomosis, anastomotic leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 4 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG Fluorescence Angiography | Experimental | Other: Visual assessmentAssess the blood supply using icg |
| Standard Visual Perfusion Assessment | Active comparator | Diagnostic Test: ICG visuals assessmentImmediate visual assessment for colon blood supply |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Undergoing elective laparoscopic colorectal resection.
- Planned primary colorectal anastomosis.
- Able and willing to provide written informed consent.
Key exclusion criteria (6 listed)
- Known allergy to iodine or indocyanine green.
- Severe hepatic dysfunction.
- Severe renal dysfunction.
- Emergency colorectal resection.
- Inflammatory bowel disease requiring extensive resection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual assessmentVisual assessment | Other | ICG Fluorescence Angiography |
| ICG visuals assessmentInjection of ICG and visually asses vascularity | Diagnostic test | Standard Visual Perfusion Assessment |
Primary outcome
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, .
3 secondary outcomes
Change in the planned bowel transection margin after ICG assessment
Time frame: One hour intraoperative
Operative time
Time frame: Hours in the operative theater
ICG-related adverse reactions, such as hypotension or allergic reaction
Time frame: 4 Hours intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim Magdy Ibrahim G. Ghallab principal investigator
ALEXANDRIA UNIVERSITY FACULTY OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual assessment and ICG visuals assessment in people with Colorectal Disease Requiring Elective Laparoscopic Resection and Colorectal Anastomotic Leak, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant anastomotic leakage (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.