Crohn's Fistula Using Porcine Intestinal Submucosal Graft
ID Number 06-1042Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to gather longer-term data on efficacy of the Surgisis® AFP in a population of patients who have Crohn’s disease. Primary endpoint of the study will be the rate of fistula closure at 12 weeks post-operatively, with additional follow-up to 6 and 12 months. The Wexner Fecal Incontinence scale will also be conducted pre-operatively and at 1 and 3 months post-operatively. A secondary endpoint would be any change in the fecal incontinence score. If statistically feasible, patients will be stratified according to their degree of Crohn’s disease (presence of active lesions or not) in order to identify a differential rate of healing.
Recruiting Patients: Yes