Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

The purpose of this study is:

Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.

Inclusion Criteria:

• Patient is ≥ 18 years old.
• Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge).
• Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
• Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

• Patient has known allergy to nickel.
• Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
• Patients are participating in another clinical trial which may affect this study's outcomes.
• Patient has been taking regular steroid medication.
• Patient has contraindications to general anesthesia.
• Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.