Receive surgery using a new bowel connection device for colon or rectal cancer

Recruiting

What is this trial?

This trial is testing a new surgical device called the C-REX RectoAid Cath that surgeons use to reconnect the bowel after removing cancer from the lower colon or upper rectum. Instead of using traditional stapling methods, this device creates a special connection by locking two silicone rings together, which may reduce complications and improve healing. The study will follow 165 patients who receive this surgery to see how well it works and how safe it is.

Standard bowel surgery uses stapling devices that have been around for many years, but surgeons believe a newer connection technique might result in better outcomes with fewer complications. This trial will help doctors understand whether this new device is a safer and more effective option for patients needing surgery to remove colon and rectal cancers.

Do you qualify?

You likely qualify if…

you have been diagnosed with cancer of the sigmoid colon or upper rectum, or a pre-cancerous growth that cannot be removed by a scope
your cancer has not spread to distant parts of your body
you are physically fit enough to have planned surgery with general anesthesia
you are able to understand the study information, give informed consent, and complete study questionnaires
you are suitable for planned laparoscopic or robotic-assisted surgery

You likely don't qualify if…

you have an emergency condition like a blocked or perforated bowel that needs immediate surgery
your cancer has spread to distant organs
you have narrowing or blockage in the bowel below where the surgery would be done
you have received prior radiation therapy to the pelvic area
you are on immunosuppressing medications like steroids or receiving immunotherapy

What participation looks like

If you are selected for this trial, you will undergo the planned surgical removal of your cancerous bowel segment using the new C-REX RectoAid Cath device to reconnect your bowel. Your surgeon will have received special training to use this device. You will need to prepare your bowel before surgery with standard bowel cleansing, and after surgery you will be followed to monitor how well the connection heals and how you recover.

New surgical connection technique for colon and rectal cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)