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

Int J Colorectal Dis. 2013 Oct;28(10):1433-8. doi: 10.1007/s00384-013-1724-7. Epub 2013 Jun 14.

Abstract

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).

MeSH terms

  • Adult
  • Aged
  • Anastomosis, Surgical / adverse effects
  • Anastomotic Leak / etiology
  • Biocompatible Materials / pharmacology*
  • Biodegradation, Environmental
  • Colon / surgery*
  • Endpoint Determination
  • Female
  • Humans
  • Male
  • Middle Aged
  • Rectum / surgery*
  • Surgical Stapling*

Substances

  • Biocompatible Materials