Thirty-seven patients treated with the C-seal: protection of stapled colorectal anastomoses with a biodegradable sheath

PURPOSE: The present study was performed to get a better insight in the incidence of anastomotic leakage leading to reintervention when using the C-seal: a biodegradable sheath that protects the stapled colorectal anastomosis from leakage. METHODS: The C-seal is a thin walled tube-like sheath that forms a protective sheath within the bowel lumen. Thirty-seven patients undergoing surgery with creation of a stapled colorectal anastomosis with C-seal were analyzed. Follow-up was completed until 3 months after surgery. RESULTS: One patient (3 %) developed anastomotic leakage leading to reintervention. None of the 37 anastomoses was dismantled. One patient was diagnosed with a rectovaginal fistula. In three patients (8 %), a perianastomotic abscess spontaneously drained. CONCLUSION: The incidence of anastomotic leakage leading to reintervention when using the C-seal (3 %) is lower than expected based on the literature (11 %). We have currently set-up a multicenter randomized trial to confirm the efficiency of the C-seal (www.csealtrial.nl).