Study of an Adaptive Anastomosis Technique Using the C-REX RectoAid Cath Device for Elective Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions

What this Trial Is About

Anastomotic leakage AL remains a serious problem after colorectal surgery, causing increased illness, death, and lower quality of life. This study evaluates an adaptive anastomosis technique using the C-REX RectoAid Cath device to reduce AL risk in patients having elective anterior resection for sigmoid or proximal rectal cancer or premalignant lesions. The study is prospective, international, and non-randomized, focusing on AL incidence and surgical outcomes. The C-REX RectoAid Cath device helps create a colorectal anastomosis by snap-locking silicone rings to hold bowel ends together without permanent staples, which may improve healing. The device is used in both open and minimally invasive surgeries by trained colorectal surgeons. The anastomotic ring naturally detaches and passes with feces about 10 days after surgery. The study includes 165 patients who undergo the procedure with the C-REX device. Participants will be monitored for 1 year after surgery. They will complete questionnaires about bowel function and healthcare use before surgery, and at 90 days and 1 year postoperatively. Researchers will assess AL rates at 30 days, 90 days, and 1 year, along with complications, readmissions, inflammatory markers, surgeon feedback, cost-effectiveness, and quality of life. Imaging with CT scan and colonoscopy will be done at 12 months to evaluate healing and anastomotic integrity.

Adaptive Anastomosis for Anterior Resection in Sigmoid and Proximal Rectal Cancer or Premalignant Lesions