An investigational temporary intraluminal bypass device could reduce the need for a diverting stoma in patients undergoing colorectal or coloanal surgery.

The Colospan (Kfar Saba, Israel) CG-100 Intraluminal Bypass Device is a silicone tubular sheath that is introduced into the colon through the anus using a designated delivery system. The protective sheath is held in place by a mechanism that consists of three inflatable balloons and an extra-luminal ring which encircles the colon, designed to prevent the silicone sheath from moving downstream from the anastomosis site.

By remaining in position without impinging, but still capable of moving freely inside the colon, the CG-100 can protect the anastomosis site from fecal material throughout the healing process, preventing it from damaging the colon wall. After approximately ten days, when the risk for leakage is reduced and anastomosis site integrity has been confirmed, the sheath and ring are removed under x-ray guidance, without the need for any further surgical intervention.

“There are limited options for patients who undergo a low resection of the colon,” said Craig Reickert, MD, head of colon and rectal surgery at Henry Ford Cancer Institute (Detroit, MI, USA). “Because the CG-100 device allows us to perform only a single minimally invasive procedure, the hope is that it can safely reduce the need for stoma and allow for a more comfortable and easy recovery, which increases the patient's quality of life and allows them to avoid the complications that some encounter with a stoma.”

Most colorectal surgeries include the formation of an anastomosis, and one of the most dangerous complications related to the anastomosis is leakage, occurring in between 5 and 20% of patients. The diverting stoma is the standard of care used to reduce morbidity associated with anastomotic leaks, but it involves a high rate of complications associated with the stoma itself, along with patient discomfort, reduced quality of life, increased hospital stay, additional surgery, and increased medical costs. And in addition to its devastating impact on patients’ lives, almost 20% of the temporary diversions eventually become permanent.

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