ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
⁃ Part 1 (pre-operative):
• 18 years or older
• Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
• Scheduled to undergo debulking or cytoreductive surgery
• Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
• Enrolled and consented before the operation
⁃ Part 2 (intra-operative):
• Completed rectosigmoid resection
• Surgeon plans to perform colorectal anastomosis