Anastomotic LeakNCT06793280
Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery
A study testing intraoperative ICG angiography and No intraoperative ICG angiography in people with Anastomotic Leak, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- intraoperative ICG angiography and No intraoperative ICG angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2022to 1 Mar 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-85 years
- Malignant colorectal tumors
- Elective surgery
Who cannot join
- Abdomino-perineal resection
- Emergency procedures
- Conversion to open surgery
- No anastomosis
- Multifocal tumors
- Locally advanced cancer (T4)
Show all 9Show fewer
- Distant metastases (M+)
- Major vasculopathies (previous PE, DVT, abdominal aorta surgery)
- ICG allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Anastomotic Leak
- Being tested
- intraoperative ICG angiography, No intraoperative ICG angiography
- Keywords
- anastomotic leak, colorectal surgery, colorectal cancer
- Medical subject headings
- Anastomotic Leak, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative ICG angiographyProcedure or surgery
Intraoperative ICG angiography to evaluate colonic perfusion
No intraoperative ICG angiographyProcedure or surgery
Visual evaluation of colonic perfusion
| Study group | Role | What they receive |
|---|---|---|
| ICG angiography | Experimental | 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. Receives: Procedure: intraoperative ICG angiography |
| No ICG angiography | Active comparator | Subjective visual measures are employed by the surgeon in order to determine anastomotic perfusion. Receives: Procedure: No intraoperative ICG angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
Measured: 90 days
Secondary outcomes (6)
Modification in the level of resection margins (cm)
Measured: intraoperative
RCP levels (POD 3, 5)
Measured: 5 days
Early complications (30 days)
Measured: 30 days
Mortality
Measured: 90 days
Hospital re-admissions
Measured: 30 days
Operative time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start22 Feb 2022
- Primary completion1 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interim analysis incoroporating a futility assessment is designed to assess whether this trial is likely to meet its objective before its completion
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Nuovo Ospedale dei Castelli, San Giovanni Addolorata Hospital
- Responsible party
- Principal investigator, Lidia Castagneto Gissey, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793280
- Sponsor's protocol ID
- 6608
- Status last verified
- May 2026
- First submitted
- 6 May 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Elective Colorectal Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06793280
- Acronym / sponsor ID
- 6608
- Conditions
- Anastomotic Leak
- Keywords
- anastomotic leak, colorectal surgery, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Nuovo Ospedale dei Castelli, San Giovanni Addolorata Hospital
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 27 Jan 2025 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- An interim analysis incoroporating a futility assessment is designed to assess whether this trial is likely to meet its objective before its completion
| Arm | Type | Receives |
|---|---|---|
| ICG angiography | Experimental | Procedure: intraoperative ICG angiographyluorescence 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. |
| No ICG angiography | Active comparator | Procedure: No intraoperative ICG angiographySubjective visual measures are employed by the surgeon in order to determine anastomotic perfusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-85 years
- Malignant colorectal tumors
- Elective surgery
Key exclusion criteria (9 listed)
- Abdomino-perineal resection
- Emergency procedures
- Conversion to open surgery
- No anastomosis
- Multifocal tumors
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 |
|---|---|---|
| intraoperative ICG angiographyIntraoperative ICG angiography to evaluate colonic perfusion | Procedure or surgery | ICG angiography |
| No intraoperative ICG angiographyVisual evaluation of colonic perfusion | Procedure or surgery | No ICG angiography |
Primary outcome
Anastomotic leak rate
Time frame: 90 days
6 secondary outcomes
Modification in the level of resection margins (cm)
Time frame: intraoperative
RCP levels (POD 3, 5)
Time frame: 5 days
Early complications (30 days)
Time frame: 30 days
Mortality
Time frame: 90 days
Hospital re-admissions
Time frame: 30 days
Operative time
Time frame: 1 day
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 20 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative ICG angiography and No intraoperative ICG angiography in people with Anastomotic Leak, run by University of Roma La Sapienza at 1 site in Italy.
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 3 inclusion and 9 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 20 May 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 Italy. 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?
Anastomotic leak rate (time frame: 90 days). 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 20 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.