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

NACompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Anal Fistula
Interventions
DEVICE

Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)

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

DEVICE

Flap

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

Trial Locations (6)

35385

Justus-Liebig-Universitat Giessen, Giessen

Unknown

Krankenhaus Waldfriede, Berlin

End-und Dickdarmzentrum Hannover, Hanover

Enddarmzentrum Mannheim, Mannheim

Caritas-Krankenhaus St. Joseph, Regensburg

St. Joseph Hospital, Wiesbaden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cook Biotech Incorporated

INDUSTRY

collaborator

Cook Ireland, Ltd.

INDUSTRY

lead

Cook Group Incorporated

INDUSTRY