This trial is terminated!
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More info
You can access this
clinical trial
if you have
Anal Fistulas
and you are
between 18 and 70
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

Surgical treatment of perianal fistulas frequently affects fecal continence. Sphincter saving techniques like loose or cutting seton and fistulectomy with advancement of an endorectal flap have been advocated to minimize the risk of sphincter injury, but patients often complain of a prolonged healing period and major discomfort. Furthermore, the healing rate varies widely according to the type of fistula and the surgeon's experience.In the early '90s the treatment of perianal fistulas by autologous or commercial fibrin glue was suggested and the American FDA approved the use and marketing of a human fibrin glue in 1998. Since then, several studies have evaluated the effectiveness of human fibrin glue in the treatment of different types of perianal fistulas, reporting a wide range of success rates ranging from 31 to 85%. Primary aim of this study is to conduct a prospective randomized trial evaluating the effectiveness of glue treatment of perianal fistulas as compared with the classical seton treatment. Secondary aims are to compare postoperative faecal incontinence, postoperative anal pain, healing time and length of hospitalization.

Provided treatments

  • Procedure: transsphincteric Seton positioning
  • Procedure: glue (Tissucol) treatment
  • Procedure: Fistula closing with biological glue
  • Procedure: Seton positioning into the fistula tract
Tris trial is registered with FDA with number: NCT00929630. The sponsor of the trial is Societa Italiana di Chirurgia ColoRettale and it is looking for 65 volunteers for the current phase.
Official trial title:
Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial