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Alternative solution to diverting stoma

The use of a diverting stoma entails clinical disadvantages and severe complications. Now there’s an alternative: a short-term, safe internal bypass with easy surgery-free removal.

Alternative solution to diverting stoma

The use of a diverting stoma entails clinical disadvantages and severe complications. Now there’s an alternative: a short-term, safe internal bypass with easy surgery-free removal.

Alternative solution to diverting stoma

The use of a diverting stoma entails clinical disadvantages and severe complications. Now there’s an alternative: a short-term, safe internal bypass with easy surgery-free removal.

Overview

Most colorectal surgeries include the formation of a colorectal anastomosis. One of the most dangerous complications related to the anastomosis is anastomotic leakage, occurring in up to 29% of the procedures. In order to prevent clinical leakage, surgeons often use an external bypass (diverting stoma), which is considered the gold standard, used in almost 70% of rectal and high-risk colon procedures.

Besides its devastating impact on patients’ quality of life, the stoma actually results in surgical complications in 17% of the cases, and almost 20% of temporary diversions eventually become permanent. Furthermore, the diverting stoma is not always successful in preventing leakage, and leak rates of 4%-10% have been reported, despite the presence of the pouch.

Different approaches have been attempted for supporting the anastomosis site during the post-surgery healing period, including various types of staple line reinforcement as well as surgical sealants and glues. However, to date, none of these methods has demonstrated clinical proof of successfully protecting the anastomotic site.

The Ostomy Pouch – Critical Health Risks, Longer Hospitalization

Today’s Ostomy Pouches Result in Critical Health Risks, Longer Hospitalization.

The major concern of colorectal surgeons is anastomotic leakage of colon content into the abdominal cavity. In many cases, colorectal surgery includes deployment of a diverting stoma, in order to prevent anastomotic leakage during the healing period of the anastomosis.

Unfortunately, the pouch itself is ridden with complications and must be deployed for a period of 3-6 months. During this period, the patient is susceptible to complications and suffers from impaired quality of life. Finally, the pouch requires an additional operation for removal, carrying risks such as a 2% leakage rate and re-operation.

The ostomy pouch is a sub-optimal solution to address anastomotic leaks following colorectal surgery. Surgeons and their patients could greatly benefit from an alternative solution which reduces risks for life-endangering complications, hospitalization and patient suffering; a solution that does not entail an additional surgical procedure for removal.

Complication-Free Insertion, Surgery-Free Removal
CG-100 – An Effective, Safe Alternative to Diverting Stoma

Colospan’s CG-100 is an innovative bypass device designed to improve the clinical outcomes of colorectal surgery. CG-100, an intraluminal device, comprises a tubular silicone sheath with 3 balloons on its distal end, mounted and folded on a delivery system assembly. Once the internal sheath is inserted into the colon using the delivery system, the device acts as an internal bypass and allows colon content to pass through it safely, while avoiding the anastomosis section. This prevents leakage into the abdominal cavity in the case of anastomosis dehiscence.

The device is inserted during the primary surgery trans-anally, anchored to the colon above the anastomosis, and deployed intraluminally to shield the anastomosis from within. Fixation is achieved by using an external silicone ring which encircles the colon on its external side, and loosely rests around the colon. The diameter of the balloon is slightly larger than that of the ring, preventing the sheath from moving downstream beyond the ring location, while still allowing it to move freely inside the colon, preventing damage to the colon wall.

After ten days, when the risk for anastomotic leakage is reduced, the sheath is removed without any additional surgical intervention. Extremely simple to apply and remove, it can be extracted at any time, requiring only a few minutes, and little training. The device is made of biocompatible materials. With its simple yet robust design, it provides 360° protection both above and below the anastomosis.

The product has undergone a series of validation and verification tests, according to international relevant standards, and risk assessment, to verify and validate the safety and effectiveness of the CG-100 device. The product has successfully undergone a FIM (First-In-Man) clinical trial in Europe, where the safety profile of the product was proved.

CG-100 is CE marked, and the company holds an ISO 13485 certificate.

Clinical Advantages

CG-100 does not require a separate operative procedure for removal, unlike the diverting stoma and other solutions. It can easily be removed at any time, surgery-free, according to the physician’s assessment of the healing process. It is usually removed after 10 days, when the risk for leakage is reduced. In clinical trials, the device was found to be easy to insert, position, and extract, and the surgeons reported it to have a high level of usability. Deployment took place with no technical difficulties or operational complications, causing no damage to the anastomosis site. Overall, the time added to the procedure on account of the CG-100 device deployment was 7 minutes on average.

CG-100 provides protection of a large area, both above and below the anastomosis, offering full coverage of the entire colon segment at risk during its healing period. The device is inserted transanally, anchored to the colon above the anastomosis, and deployed intraluminally to cover the anastomosis from within. An external ring encircles the colon 10 cm proximal to the anastomosis site to prevent the internal sheath from migrating. This structure allows CG-100 to safely and efficiently reduce contact between fecal content and the anastomosis.

CG-100 allows evaluation of the anastomosis before extraction, to ensure it has healed properly. This is performed through radiologic testing of the anastomosis integrity by injection of contrast material into the space between the internal sheath and the bowel mucosa. Potentially, in cases of a radiologically confirmed anastomotic leak, the device can be kept in situ up to 28 days to provide continued protection. This possibility is available since, unlike other intracolonic devices, the CG-100 is actively extracted and is not dependent on material or suture degradation.