The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

Phase 2

• Conditions: Colon Neoplasms; Rectal Neoplasms; Inflammatory Bowel Disease; Diverticular Disease
• Interventions: Procedure: Near-infrared ICG fluorescence imaging; Procedure: Traditional bowel anastomosis; Device: FireFly™

• Registration Number: NCT02598414
• Lead Sponsor: Acibadem University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-11-24
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bowel Anastomosis Under ICG Guidance	Near-infrared ICG fluorescence imaging	Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
Bowel Anastomosis Under ICG Guidance	FireFly™	Patients undergo robotic colon/rectal resection and anastomosis with near-infrared ICG fluorescence imaging.
Standard Bowel Anastomosis	Traditional bowel anastomosis	Patients undergo robotic colon/rectal resection and anastomosis without near-infrared ICG fluorescence imaging.

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	Postoperative 30 days	Anastomotic leak rate within 30 post operative days

Secondary Outcome Measures

Name	Time	Method
Complication rate	Postoperative 30 days	Complication rate within postoperative 30 days
Mortality	Postoperative 30 days	Mortality within 30 post operative days

Trial Locations

Locations (1)

Acibadem University; 🇹🇷 İstanbul, Turkey