Complex Anal Fistulas Clinical Trial
Official title:
Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence up to 1 Year Follow-up
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
Perianal fistula is a rare disease characterized by a tract that connects the perineal skin to the anal canal. These fistulas usually lead to anal pain, intermittent anal purulent discharge and abscess recurrence. The choice of the treatment depends on the type of fistula, simple or complex fistulas. Simple fistulas are defined as inter-sphincteric and trans-sphincteric fistulas involving less than 30 % of the external sphincter. Complex anal fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas or fistulas involving multiple tracts, anal fistulas associated with inflammatory bowl disease, radiation, malignancy, preexisting fecal incontinence or chronic diarrhea. While treatments in one stage (including fistulotomy (laying open the fistula tract) and fistulectomy (excision of the fistula tract) have shown an acceptable benefit (healing) / risk (incontinence) balance for the treatment of simple fistulas and have become the treatment of choice, there is a risk of incontinence in up to 80 % of patients with a complex fistula after one stage treatment. Alternative "sphincter-saving techniques" have been developed. However, none have shown evidence of superiority in terms of healing rate or anal incontinence. It therefore seems appropriate to develop new treatment alternatives for patients with a complex anal fistula. The clinical investigation is designed to evaluate the global healing rate of complex anal fistulas after radiofrequency procedure using the Fistura® procedure. Healing rate will be evaluated clinically and by performing an MRI. Secondary outcomes include healing rate per type of fistulas, assessment of anal incontinence, energy used and duration of the procedure, return to daily activities and work, quality of life and postoperative complications. ;