Multicentre phase II trial of near-infrared imaging in elective colorectal surgery

BackgroundDecreasing anastomotic leak rates remain a major goal in colorectal surgery. Assessing intraoperative perfusion by indocyanine green (ICG) with near-infrared (NIR) visualization may assist in selection of intestinal transection level and subsequent anastomotic vascular sufficiency. This study examined the use of NIR-ICG imaging in colorectal surgery. MethodsThis was a prospective phase II study (NCT02459405) of non-selected patients undergoing any elective colorectal operation with anastomosis over a 3-year interval in three tertiary hospitals. A standard protocol was followed to assess NIR-ICG perfusion before and after anastomosis construction in comparison with standard operator visual assessment alone. ResultsFive hundred and four patients (median age 64years, 279 men) having surgery for neoplastic (330) and benign (174) pathology were studied. Some 425 operations (853 per cent) were started laparoscopically, with a conversion rate of 59 per cent. In all, 220 patients (437 per cent) underwent high anterior resection or reversal of Hartmann's operation, and 90 (179 per cent) low anterior resection. ICG angiography was achieved in every patient, with a median interval of 29s to visualization of the signal after injection. NIR-ICG assessment resulted in a change in the site of bowel division in 29 patients (58 per cent) with no subsequent leaks in these patients. Leak rates were 24 per cent overall (12 of 504), 26 per cent for colorectal anastomoses and 3 per cent for low anterior resection. When NIR-ICG imaging was used, the anastomotic leak rates were lower than those in the participating centres from over 1000 similar operations performed with identical technique but without NIR-ICG technology. ConclusionRoutine NIR-ICG assessment in patients undergoing elective colorectal surgery is feasible. NIR-ICG use may change intraoperative decisions, which may lead to a reduction in anastomotic leak rates. Appears to reduce leaks