Anal Fistulas Clinical Trial
Official title:
Seton or Glue for Trans-sphincteric Anal Fistulas. A Prospective Randomised Clinical Trial
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.
Background: Fibrin glue treatment of anal fistulas has been proposed to minimize the risk of
faecal incontinence but its acceptance by coloproctologists is still poor because clear data
in literature are lacking. We will run a prospective randomised trial comparing commercial
fibrin glue treatment with classical seton treatment, taking into account the healing rate,
hospital stay, healing time, faecal incontinence and postoperative pain.
Patients and Methods: 130 homogeneous patients with trans-sphincteric anal fistulas referred
to 7 Colorectal Units will be randomised to undergo fibrin glue or seton treatment.
permanent healing of the fistula will be defined as absence on any discharge from the
fistula and healing of the secondary fistula orifice after at least 1 year of follow up.
Post operative pain (on a VAS scale) and hospital stay will be recorded and compared in the
two groups
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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