A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas

Cook Group Incorporated86 enrolled

Overview

The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anal Fistula

Interventions

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)DEVICE

Surgical placement of the Surgisis AFP is performed under general anesthesia.

FlapDEVICE

Advancement flap surgery is performed; no anal fistula plug is placed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over eighteen years old * Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature * Pre-placement of seton required for at least 6 weeks prior to surgical treatment * Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer Exclusion Criteria: * Recurrent fistula tracts * J-pouch fistulas * Superficial fistulas * Fistulas with active abscess, infection, or acute inflammation * History of Chron's Disease * History of Ulcerative Colitis * History of HIV or other immune system disease * History of collagen disease * History of radiation to the anorectal region * Allergies to pig tissue or pig products * Religious or cultural objection to the use of pig tissue

Locations (6)

Justus-Liebig-Universitat Giessen

Giessen, Giessen, Germany

Krankenhaus Waldfriede

Berlin, Germany

End-und Dickdarmzentrum Hannover

Hanover, Germany

Enddarmzentrum Mannheim

Mannheim, Germany

Outcomes

Primary Outcomes

Healing Success

Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

Time frame: 12 months

Data from ClinicalTrials.gov

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