Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery
Launched by UNIVERSITY OF ROMA LA SAPIENZA · Jan 23, 2025
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a technique called indocyanine green (ICG) angiography to see if it can help reduce the risk of a problem known as anastomotic leak during colorectal surgery. An anastomotic leak occurs when there is a breakdown at the connection point between two sections of the intestine after surgery, which can lead to serious complications. The trial will involve 561 adults aged 18 to 85 who are scheduled for elective surgery to remove cancerous tumors in the colon or rectum. Participants will be divided into two groups: one group will have their blood flow to the intestine checked using ICG angiography, while the other group will have the surgery based on the surgeon’s judgment without this technique.
If you or a loved one is eligible, you can expect to be part of a study that aims to improve surgical outcomes and possibly lower the chances of complications related to colorectal cancer surgery. Participants should be aware that certain conditions may exclude them from the trial, such as having an allergy to ICG or needing emergency surgery. Ultimately, this study hopes to provide valuable information on whether using ICG angiography makes a difference in surgical success for patients with colorectal cancer.
Gender
ALL
Eligibility 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
About University Of Roma La Sapienza
The University of Roma La Sapienza, one of Italy's premier research institutions, is dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in diverse fields, including medicine, biotechnology, and public health, to conduct rigorous and ethically sound research. Committed to fostering educational excellence and promoting groundbreaking discoveries, La Sapienza actively engages in clinical trials that aim to address critical health challenges and contribute to the development of new therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported