Protection of stapled colorectal anastomoses with a biodegradable device: the C-Seal feasibility study.

BACKGROUND: A colorectal anastomotic leak can be life-threatening. We have assessed the feasibility of a new intraluminal biodegradable bypass device that we designed to avoid anastomotic leakage and the necessity of a temporary stoma. METHODS: Fifteen patients underwent colorectal surgery. Before performing the anastomosis in a standard way, the C-Seal (Polyganics BV, Groningen, The Netherlands) was glued to the anvil of the circular stapler. Consequently, the bypass was fixated in the staple row just proximal of the simultaneously made anastomosis. A water-soluble contrast enema was performed after 1 week. RESULTS: The sheath was well compatible with the standard stapler device and easy to use. All donuts remained intact. No radiologic or clinical leaks were observed after surgery. CONCLUSIONS: This pilot study shows that the C-Seal can be applied successfully in colorectal surgery. Further investigation with large numbers of patients is now necessary to assess the efficacy of the C-Seal as a protective device