A randomized clinical trial comparing surgisis AFP to advancement flap for the repair of anal fistulas: TS04


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Abstract

Aim:Successful repair of anal fistulas remains elusive. The anal fistula plug was developed as a minimally-invasive, sphincter-sparing option to fistula repair but the effectiveness of the plug is bimodal, with centres reporting success rates that range from under 20% to > 80%. Clearly, the amount of level one clinical data is limited, and carefully controlled studies are needed to directly compare the plug's effectiveness with other treatment methods. This multicentre,prospective, randomized clinical trial is being conducted at 6 centres across Germany to compare the effectiveness of the Surgisis® Anal Fistula Plug to the advancement flap for the repair of complex anal fistulas. The study is designed to compare the healing rates of fistulas in each study group at 12 months postsurgery, with healing being defined as “closure of external fistula opening with absence of abscess, drainage and pain,” as assessed by clinical exam and ultrasound.Method:The study will enroll 106 adult patients (53 per group) withprimary, persistent, complex anal fistulas who have had a draining seton in place for at least 6 weeks. Patients with Crohn's Disease, Ulcerative Colitis, immune system disease, and history of radiation to the anorectal region are excluded, as are patients whose fistula tracts show signs of abscess or active infiammation. The formalstudy hypothesis is: “The Surgisis® AFP is as effective as advancement flap repair for the treatment ofprimary transsphincteric, suprasphincteric, or extrasphincteric anal fistulas.” Secondary study endpoints are changes in the quality of life score (EQ5D and FIQL) at 3, 6 and 12 months, the change in continence (FISI scale) at 3, 6 and 12 months, and incidence of healing at 6 months. Time in the operating theatre is also being captured. Sample size was determined by assuming a 70% success for the Surgisis® AFP and 55% for the advancement flap, with α = 0.05, β = 0.2, and a noninferiority margin of 10%. The study will target a total of 106 subjects to allow for subjects lost to follow-up. Enrolment began in late 2008 and is expected to be complete in December 2010 or early 2011, with 1-year data collected and analysed forpresentation in late 2011 or early 2012. This study is being funded by Cook Medical.

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