Gore Bio-A® Fistula Plug: a new sphincter-sparing procedure for complex anal fistula.

AIM: The surgical treatment of a complex anal fistula remains controversial, although 'sphincter-saving' operations are desirable. The Gore Bio-A® Fistula Plug is a new bioprosthetic plug that has been proposed for the treatment of complex anal fistula. This study reports preliminary data following implantation of this plug.

METHOD: Eleven patients with a complex anal fistula underwent insertion of Gore Bio-A® Fistula Plugs. The disc diameter and number of tubes in the plug were adapted to the fistula to allow accommodation of the disc into a submucosal pocket, and the excess tubes were trimmed. During the follow-up period, patients underwent clinical and physical examinations and three-dimensional endoanal ultrasound.

RESULTS: Fistulas were high anterior transphincteric in five patients and high posterior transphincteric in six patients. All patients had a loose seton placement before plug insertion. Two, three and four tubes were inserted into the fistula plug in seven, three and one patient, respectively. The median follow-up period was 5 months. No patient reported any faecal incontinence. There was no case of early plug dislodgement. Treatment success was noted for eight (72.7%) of 11 patients at the last follow-up appointment.

CONCLUSION: Implanting a Gore Bio-A® Fistula Plug is a simple, minimally invasive, safe and potentially effective procedure to treat complex anal fistula. Patient selection is fundamental for success.