Phase III Study of Near-Infrared Angiography to Reduce Complications During Rectosigmoid Surgery in Women With Ovarian Cancer

What this Trial Is About

Researchers are studying whether using the PINPOINT imaging system during surgery can lower the risk of complications like anastomotic leaks after bowel surgery in women with ovarian cancer. This system uses a special camera and glowing dye to check blood flow in the bowel in real time. The study compares this new imaging method with the usual surgical assessments to see if it improves outcomes. Participants will be randomly assigned to one of two groups one group will receive the standard surgical technique without the imaging system, and the other will have the additional PINPOINT imaging to assess blood flow before and after the bowel connection is made. The imaging involves an intravenous injection of a fluorescent dye and the use of the PINPOINT camera to guide the surgeon during the operation. During the study, participants will be monitored for complications within 30 days after surgery, focusing on the occurrence of leaks at the bowel connection site. The main outcome is the reduction in risk of these leaks. The study involves assessments before, during, and after surgery, with follow-up up to 45 days after the procedure. The trial is conducted without masking, and it is sponsored by Memorial Sloan Kettering Cancer Center.

A Study of Intra-operative Imaging in Women With Ovarian Cancer