Using indocyanine green to assess blood flow during colorectal surgery
Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Elective Colorectal Surgery: Randomized Controlled Trial
NA · University of Roma La Sapienza · NCT06793280
This study is testing if using a special dye during colorectal surgery can help doctors see blood flow better and reduce the risk of complications for patients with colon cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 562 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza (other) |
| Locations | 1 site (Roma, Italy) |
| Trial ID | NCT06793280 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of indocyanine green (ICG) angiography in assessing colonic perfusion during colorectal surgery to reduce the risk of anastomotic leaks. The study compares outcomes between patients who receive ICG angiography and those who do not during elective surgeries for malignant colorectal tumors. By objectively measuring blood supply to the intestines, the trial aims to improve surgical outcomes and reduce complications associated with inadequate perfusion. The study includes patients aged 18-85 with specific eligibility criteria to ensure safety and relevance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-85 undergoing elective surgery for malignant colorectal tumors.
Not a fit: Patients with conditions such as abdomino-perineal resection, emergency procedures, or those with advanced cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of anastomotic leaks in colorectal surgery, leading to better patient outcomes.
How similar studies have performed: While there has been limited research on ICG angiography in colorectal surgery, previous studies suggest potential benefits, indicating this approach is still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-85 years * Malignant colorectal tumors * Elective surgery Exclusion Criteria: * Abdomino-perineal resection * Emergency procedures * Conversion to open surgery * No anastomosis * Multifocal tumors * Locally advanced cancer (T4) * Distant metastases (M+) * Major vasculopathies (previous PE, DVT, abdominal aorta surgery) * ICG allergy
Where this trial is running
Roma, Italy
- Lidia Castagneto Gissey — Roma, Italy, Italy (RECRUITING)
Study contacts
- Study coordinator: Lidia Castagneto Gissey, MD, PhD
- Email: lidia.castagnetogissey@uniroma1.it
- Phone: 3403497741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anastomotic Leak, anastomotic leak, colorectal surgery, colorectal cancer