Clinical trial · Interventional
A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)
NCT03390517CI-TRIAL-00040847FLAGcompletedN/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 study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Sigmoid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence angiography with indocianyne green | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICG group
- description
- A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice with the addition of intraoperative imaging using fluorescence angiography with indocianyne green to assess colon and rectal tissue perfusion.
- interventionNames
- Device: Fluorescence angiography with indocianyne green
- type
- NO_INTERVENTION
- label
- Standard
- description
- A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice.
Primary outcomes (1)
- measure
- Anastomotic Leak Rate
- timeFrame
- 0 to 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a planned circular stapled colorectal anastomosis * Have signed an approved informed consent form for the study Exclusion Criteria: * Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.
References
Publications (0)
Data not yet available
No reference posted for this study.