title: Gore Bio-A® Fistula Plug: a new sphincter-sparing procedure for complex anal fistula.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgical Sciences, Catholic University, Rome, Italy. carloratto@tiscali.it
authors.forename: C
authors.initials: C
authors.lastname: Ratto
authors.forename: F
authors.initials: F
authors.lastname: Litta
authors.forename: A
authors.initials: A
authors.lastname: Parello
authors.forename: L
authors.initials: L
authors.lastname: Donisi
authors.forename: G
authors.initials: G
authors.lastname: Zaccone
authors.forename: V
authors.initials: V
authors.lastname: De Simone
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects; D000328:Adult; D000368:Aged; D001003:Anal Canal; D019160:Endosonography; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D059351:Organ Sparing Treatments; D011108:Polymers; D012003:Rectal Fistula / Q000000981:diagnostic imaging / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011108:Polymers; C046409:polyglyconate