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

Not Applicable

Completed

• Conditions: Anal Fistula
• Interventions: Device: Flap; Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

• Registration Number: NCT00545441
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Study Start: 2008-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-10-24
• Results First Submitted QC: 2014-10-24
• Results First Posted: 2014-10-29
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Flap	Flap
1	Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)	Surgisis® AFP

Primary Outcome Measures

Name	Time	Method
Healing Success	12 months	Healing was defined as "closure of external opening with absence of abscess, drainage and pain."

Trial Locations

Locations (6)

Krankenhaus Waldfriede; 🇩🇪 Berlin, Germany

End-und Dickdarmzentrum Hannover; 🇩🇪 Hannover, Germany

Enddarmzentrum Mannheim; 🇩🇪 Mannheim, Germany

Justus-Liebig-Universitat Giessen; 🇩🇪 Giessen, Germany

Caritas-Krankenhaus St. Joseph; 🇩🇪 Regensburg, Germany

St. Joseph Hospital; 🇩🇪 Wiesbaden, Germany