Clinical trial · Interventional
The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment. An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results. Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms Malignant | — | UNRESOLVED | — |
| Colo-rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Bowel Anastomosis group | Other | — | UNRESOLVED |
| ICG-guided bowel perfusion assessment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The ICG group
- description
- The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.
- interventionNames
- Drug: ICG-guided bowel perfusion assessment
- type
- PLACEBO_COMPARATOR
- label
- The control group
- description
- The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
- interventionNames
- Other: Conventional Bowel Anastomosis group
Primary outcomes (1)
- measure
- 30-days Anastomotic Leakage (AL) rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged over 18 years old * ECOG status 0-2 * Written informed consent * histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid) * Scheduled for colorectal resection with primary anastomosis Exclusion Criteria: * Pregnancy or breast feeding * Colon obstruction, perforation or bleeding complicating the tumor * Medical contraindications for surgical treatment * Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
References
Publications (0)
Data not yet available