Clinical trial · Observational
Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery
Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery: A Prospective Single-Center Observational Study With a Historical Control Group
- 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 remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact remains controversial. This prospective single-center observational study evaluated the association between intraoperative use of ICG-FA and postoperative outcomes in patients undergoing laparoscopic sigmoid or rectal cancer surgery. Outcomes of patients assessed with ICG-FA were compared with those of a historical control cohort treated without fluorescence imaging.
Conditions
Conditions (3)
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 (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer Surgery | — | UNRESOLVED | — |
| Sigmoid Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- ICG-FA group
- description
- Prospective cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery with intraoperative indocyanine green fluorescence angiography for bowel perfusion assessment.
- label
- Control group
- description
- Historical control cohort of patients undergoing laparoscopic sigmoid or rectal cancer surgery without fluorescence imaging.
Primary outcomes (1)
- measure
- Anastomotic Leakage Rate
- timeFrame
- Within 30 days after surgery
- description
- Incidence of anastomotic leakage defined according to the International Study Group of Rectal Cancer criteria.
Secondary outcomes (6)
- measure
- Overall Postoperative Complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed or clinically suspected sigmoid or rectal adenocarcinoma * Elective laparoscopic resection with curative intent and planned colorectal/coloanal anastomosis * Ability to provide informed consent Exclusion Criteria: * Pregnancy or breastfeeding * Known hypersensitivity to indocyanine green or iodine * Emergency surgery * Planned end colostomy without anastomosis * Conversion to open surgery
References
Publications (1)
- DERIVEDSemeniv S, Pedziwiatr M, Rymarowicz J, Szpakowska A, Jurczak M, Putowski M, Rubinkiewicz M. Indocyanine green fluorescence angiography in laparoscopic sigmoid and rectal cancer surgery: no reduction in anastomotic leakage but a lower incidence of anastomotic strictures. A prospective single-center study. Front Surg. 2026 Jun 25;13:1822071. doi: 10.3389/fsurg.2026.1822071. eCollection 2026. PMID 42428782