Phase III Study of Intraoperative Indocyanine Green Fluorescence to Prevent Anastomotic Leak in Colorectal Cancer Surgery

What this Trial Is About

Colorectal cancer CRC is a common cancer worldwide, with an increasing incidence, especially in developing countries. A serious complication after colorectal surgery for left-sided or high rectal cancer is anastomotic leakage AL, which can lead to death, longer hospital stays, worsened quality of life, and higher medical costs. This trial evaluates whether using intraoperative fluorescence angiography IOFA with indocyanine green ICG during surgery can reduce the rate of AL compared to standard surgery without IOFA. In this phase III, national, multicenter, single-blind randomized trial, adult patients scheduled for elective left colectomy or high rectal resection with intraperitoneal anastomosis are assigned to one of two groups. The experimental group receives surgery with IOFA where ICG is injected intravenously to assess blood flow in the colon before performing the anastomosis. The control group undergoes surgery without the use of IOFA. The study includes 1010 patients across 26 centers, with follow-up visits up to 90 days after surgery. Participants are involved in three main visits a pre-operation visit for screening and consent, surgery with or without IOFA, and follow-up visits at 30 and 90 days post-operation. Researchers collect clinical data, quality of life questionnaires, and monitor for AL occurrence. The primary outcome is the rate of AL within 90 days after surgery. Secondary outcomes include changes in surgical plans, stoma rates, complications, mortality, hospital stay length, reinterventions, and cost analysis. Patient safety and health are carefully monitored throughout the study period.

Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage