Clinical trial · Interventional
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
- 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)
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time. Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Diverticular Disease | — | UNRESOLVED | — |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FireFly™ | Device | — | UNRESOLVED |
| Near-infrared ICG fluorescence imaging | Procedure | — | UNRESOLVED |
| Traditional bowel anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bowel Anastomosis Under ICG Guidance
- description
- Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
- interventionNames
- Procedure: Near-infrared ICG fluorescence imaging
- Device: FireFly™
- type
- ACTIVE_COMPARATOR
- label
- Standard Bowel Anastomosis
- description
- Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.
- interventionNames
- Procedure: Traditional bowel anastomosis
Primary outcomes (1)
- measure
- Anastomotic leak rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is able to give informed consent for participation in the study * Subject is willing and able to comply with the study procedures * Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision * Subject is scheduled for robotic colon or rectal resection * A negative pregnancy test for women of childbearing potential prior to surgery Exclusion Criteria: * Subjects present with bowel obstruction or perforation * Subject undergo emergency surgery * Subject with ASA IV, V * History of allergy or hypersensitivity against indocyanine green * Pregnant or breast-feeding women * Subject has uremia (serum creatinine \>2.5 mg/dl) * Subject is undergoing palliative surgery or who is terminally ill * Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery * Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid
References
Publications (2)
- RESULTRis F, Hompes R, Cunningham C, Lindsey I, Guy R, Jones O, George B, Cahill RA, Mortensen NJ. Near-infrared (NIR) perfusion angiography in minimally invasive colorectal surgery. Surg Endosc. 2014 Jul;28(7):2221-6. doi: 10.1007/s00464-014-3432-y. Epub 2014 Feb 25. PMID 24566744
- RESULTJafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28. PMID 25451666