Clinical trial · Interventional
Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage
NCT03602677CI-TRIAL-00065047ICG-COLORALunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Diverticulosis, Colonic | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG fluorescence imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICG fluorescence imaging
- description
- Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.
- interventionNames
- Device: ICG fluorescence imaging
- type
- NO_INTERVENTION
- label
- Standard procedure
- description
- Standard colorectal surgery and anastomosis.
Primary outcomes (1)
- measure
- Anastomosis leakage rate
- timeFrame
- 0 to 90 days
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study. * Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold). Exclusion Criteria: * Emergent patients * Patients with proven diverticular abscess and colonic fistulas are excluded * Patients with planned open surgery are excluded.
References
Publications (1)
- DERIVEDRinne JKA, Huhta H, Pinta T, Turunen A, Mattila A, Tahkola K, Helminen O, Ohtonen P, Rautio T, Kossi J. Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage: A Randomized Clinical Trial. JAMA Surg. 2025 May 1;160(5):486-493. doi: 10.1001/jamasurg.2025.0006. PMID 40042831