Clinical trial · Observational
Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis
Indocyanine Green Enhanced Fluorescent Angiography: Can it Predict Anastomotic Leakage (AL) After Recto-sigmoid Resection for Malignancy, and Are we Able to Evaluate the Findings? -A Small Multi-centre Trial 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)
A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is suggested that using this procedure the relative risk of AL is reduced about 54-67%. With this project we wish to evaluate the feasibility of the procedure, and, if proven feasible, to plan further studies evaluating the procedure.
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 |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescent Imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of patients with anastomotic leakage and evaluation of fluorescent imaging in these patients
- timeFrame
- 30 days
- description
- Primary surgeons peroperative evaluation of fluoresence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * robotic surgery for rectal cancer and cancers located low in the sigmoid bowel Exclusion Criteria: * Allergy of iodide * Pregnancy * Lactation
References
Publications (1)
- DERIVEDLarsen PO, Nerup N, Andersen J, Dohrn N, Klein MF, Brisling S, Salomon S, Andersen PV, Moller S, Svendsen MBS, Rahr HB, Iversen LH, Gogenur I, Qvist N, Ellebaek MB. Anastomotic perfusion assessment with indocyanine green in robot-assisted low-anterior resection, a multicenter study of interobserver variation. Surg Endosc. 2023 May;37(5):3602-3609. doi: 10.1007/s00464-022-09819-1. Epub 2023 Jan 9. PMID 36624218