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,\r\nalthough 'sphincter-saving' operations are desirable. The Gore Bio-A® Fistula\r\nPlug is a new bioprosthetic plug that has been proposed for the treatment of\r\ncomplex anal fistula. This study reports preliminary data following implantation \r\nof this plug.\r\nMETHOD: Eleven patients with a complex anal fistula underwent insertion of Gore\r\nBio-A® Fistula Plugs. The disc diameter and number of tubes in the plug were\r\nadapted to the fistula to allow accommodation of the disc into a submucosal\r\npocket, and the excess tubes were trimmed. During the follow-up period, patients \r\nunderwent clinical and physical examinations and three-dimensional endoanal\r\nultrasound.\r\nRESULTS: Fistulas were high anterior transphincteric in five patients and high\r\nposterior transphincteric in six patients. All patients had a loose seton\r\nplacement before plug insertion. Two, three and four tubes were inserted into the\r\nfistula plug in seven, three and one patient, respectively. The median follow-up \r\nperiod was 5 months. No patient reported any faecal incontinence. There was no\r\ncase of early plug dislodgement. Treatment success was noted for eight (72.7%) of\r\n11 patients at the last follow-up appointment.\r\nCONCLUSION: Implanting a Gore Bio-A® Fistula Plug is a simple, minimally\r\ninvasive, safe and potentially effective procedure to treat complex anal fistula.\r\nPatient selection is fundamental for success.