Prospective Multicenter Study of a Synthetic Bioabsorbable Anal Fistula Plug to Treat Cryptoglandular Transsphincteric Anal Fistulas

Abstract

Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.

Predictive factors for recurrence of cryptoglandular fistulae characterized by preoperative three‐dimensional endoanal ultrasound

“…For higher and more complex fistulae several sphincter-preserving operations are available including fibrin glue injection, anal fistula plug insertion, mucosal advancement flap, fistulectomy or ligation of the intersphincteric fistula tract. Although short-term results of fibrin glue injections seemed promising, prospective clinical trials showed recurrence rates of 46-86% [18][19][20][21]. Anal fistula plugs showed a similar trend and larger more recent studies have shown recurrence rates of 66-83% [13,22].…”

Management of Complex Anal Fistulas

“…The Gore Bio-A fistula plug (Gore Medical, Flagstaff, AZ) is a synthetic bioabsorbable scaffold that acts in a manner similar to the Surgisis plug, but for a reportedly cheaper price, and with the addition of several "tentacles" that can be removed or adjusted in a fashion tailored to the size and number of fistula tracts. 60 Initial primary healing with this plug was reported at 69%, 61 but a subsequent multicenter case series reported a 12-month healing rate of 49%. 60 Overall, the AFP appears to be an acceptable approach to complex anal fistulas, as it is generally well tolerated with minimal side effects.…”

The treatment of anal fistula: secondACPGBIPosition Statement – 2018

“…Benefits in favour of the fistula plug include ease of use and lack of complications. No differences in complication rates have been reported between ERAF and AFP [181], with documented complications including sepsis/abscess, recurrence and constipation [183,185,186]. Unlike some other techniques, no study has reported a detrimental effect to continence following use of a plug.…”