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FLUOCOL-1 : Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
EU CTIS ID: 2024-515118-42-00
What this study is testing
To demonstrate that the assessment of anastomotic perfusion using intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) will reduce AL in left-sided or high anterior resection with intraperitoneal anastomosis.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- Signed informed consent
- Affiliated to the French social security system (CMU included).
- Adult patients (age >18 years)
You likely can't join if
- Emergent surgery
- Inflammatory bowel disease
- History of known allergy to indocyanine
- Pregnant patients
- Refusal to participate or inability to provide informed consent
- Protected adults (individuals under guardianship by court order).
See the full eligibility criteria
- Scheduled to undergo elective left colectomy or high rectal resection for cancer with intraperitoneal anastomosis.
- Signed informed consent
- Affiliated to the French social security system (CMU included).
- Adult patients (age >18 years)
- Emergent surgery
- Inflammatory bowel disease
- History of known allergy to indocyanine
- Pregnant patients
- Refusal to participate or inability to provide informed consent
- Protected adults (individuals under guardianship by court order).
- Rectal cancer requiring total mesorectal excision and anastomosis below the peritoneal reflexion
- Colon cancer requiring total or subtotal colectomy defined as a right colectomy extended to the splenic flexure or more)
- Colon cancer requiring transverse colectomy
- Recurrent colorectal cancer
- Locally advanced colorectal cancer requiring multi-visceral excision
- History of colectomy
- Associated concomitant resection of other organ (liver, etc.)
- Previous pelvic radiotherapy for pathology unrelated to diagnosis with colon cancer e.g. treatment for prostate cancer
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.