Colon Neoplasms, Diverticular Disease, Inflammatory Bowel Disease, Rectal Neoplasms
Conditions
Keywords
Colorectal Disease, Robotic Surgery, Indocyanine Green Fluorescence Imaging, Anastomotic Leak, Short-term Outcomes
Brief summary
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.
Interventions
PROCEDURENear-infrared ICG fluorescence imaging
Patient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
PROCEDURETraditional bowel anastomosis
Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
DEVICEFireFly™
The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
Sponsors
Acibadem Atakent University Hospital
Acibadem University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak rate | Postoperative 30 days | Anastomotic leak rate within 30 post operative days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Postoperative 30 days | Complication rate within postoperative 30 days |
| Mortality | Postoperative 30 days | Mortality within 30 post operative days |
Countries
Turkey (Türkiye)
Contacts
Primary ContactVolkan Ozben, MD
Outcome results
None listed