Initial experience on efficacy in closure of cryptoglandular and Crohn’s transsphincteric fistulas by the use of the anal fistula plug

It was the aim of this prospective study to analyze the efficacy of the Cook Surgisis® AFP™ anal fistula plug (AFP) for the closure of cryptoglandular and Crohn’s disease-associated transsphincteric anorectal fistulas.

All patients with transsphincteric anorectal fistulas who underwent a surgical procedure using the AFP were prospectively enrolled in this study. Inclusion criteria included transsphincteric, single-tract fistulas. Patients’ demographics, fistula etiology, surgical variables, continence (Cleveland Clinic Florida incontinence score), quality of life (fecal incontinence quality of life), and success rates were prospectively recorded. Surgery was performed in a standardized technique including irrigation of the fistula tract, placement, and internal fixation of the Cook Surgisis® AFP™ anal fistula plug. No flap or excision of the fistula tract was performed. Success was defined as closure of both internal and external openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was derived from clinical examination 3, 6, 9, and 12 months postoperatively.

Within 6 months (August 2006 to January 2007), a total of 19 AFPs were inserted in 19 patients (8 females, 11 males; mean age, 38 years). Out of 19 patients, 12 had cryptoglandular and 7 had Crohn’s associated transsphincteric fistulas. Three patients were smokers, one patient had methicillin-resistant Staphylococcus aureus infection. Mean operative time was 15 min (range, 8–22); no morbidity occurred. After a mean follow-up of 279 days (SD = 68.0) and one patient lost to follow-up, the overall success rate was 61% (12 of 18) at 9 months postoperatively. Focusing solely on cryptoglandular fistulas, the success rate was 45.5% (5 of 11), whereas it was 85.7% (6 of 7) in transsphincteric fistulas associated with Crohn’s disease. Five patients with failure of AFP (plug dislodgement, n = 2; persistent secretion, n = 3) had reoperation (27.8%). The reasons for failure were infection requiring drainage (n = 2) and persistent drainage (n = 3). No deterioration of continence was documented.

The success rate for the Cook Surgisis® AFP™ anal fistula plug for the closure of complex anorectal fistulas both in cryptoglandular and Crohn’s associated fistulas was 45.5 and 85.7%, respectively. Further analysis is needed to explain the definite role of this innovative technique in comparison to traditional surgical techniques.