ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer

Summary

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.

Eligibility

Age range

Not specified

Sex

Female

Healthy volunteers

No

Interventions

• Diagnostic Test
  Intravenous Indocyanine Green/ICG injection

  Intravenous Indocyanine Green/ICG injection will be administered for visualization

• Diagnostic Test
  PINPOINT endoscopic fluorescence imaging system

  After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.

• Diagnostic Test
  Endoscopy

  Standard technique and assessment of anastomosis without the use of NIR angiography

Locations (9)