Skip to main content
SpringerLink
Log in

Collagen Fistula Plug for the Treatment of Anal Fistulas

  • Original Contribution
  • Published:
Diseases of the Colon & Rectum

Abstract

PURPOSE

This study was designed to evaluate the efficacy of the Surgisis® (Anal Fistula Plug™) in multiple patients at our institution and present early clinical results along with notable clinical observations from our experience.

METHODS

This was a prospective analysis of all patients who received the Anal Fistula Plug™ for treatment of anorectal fistulas between April 2006 and February 2007. All tracts were irrigated with peroxide, the plug was inserted in the tract, and buried at the internal opening with 2-0 vicryl and mucosal advancement flap. Statistical analysis was performed with Fisher’s exact test.

RESULTS

Forty-five patients were treated with the Anal Fistula Plug™ and one patient was lost to follow-up. There were 27 males and 17 females with average age of 44.1 years treated for simple (n = 24) or complex (n = 20) fistulas. Preliminary results indicated an 84 percent healing rate by 3 to 8 weeks postoperatively, which progressively declined from 72.7 percent at 8 weeks to 62.4 percent at 12 weeks and 54.6 percent at a median follow-up of 6.5 (range, 3–13) months. Long-term Anal Fistula Plug™ closure rate was significantly higher in patients with simple than complex fistulas (70.8 vs. 35 percent; P < 0.02) and with non-Crohn’s disease vs. Crohn’s disease (66.7 vs. 26.6 percent; P < 0.02). Patients with two successive plug placements had significantly lower closure rates than patients who underwent placement of the plug once (12.5 vs. 63.9 percent; P < 0.02). No significant difference in closure rates were found between patients with one vs. multiple fistula tracts. Postoperative complications included perianal abscess in five patients (3 Crohn’s disease, 2 non-Crohn’s disease).

CONCLUSIONS

Anal Fistula Plug™ is most successful in the treatment of simple anorectal fistulas but is associated with a high failure rate in complex fistula and particularly in patients with Crohn’s disease. Repeat plug placement is associated with increased failure. Given the relatively low morbidity associated with the procedure, Anal Fistula Plug™ should be considered as a first-line treatment for patients with simple fistulas and as an alternative in selected patients with complex fistulas.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1

Similar content being viewed by others

References

  1. Schouten WR, Zimmerman DD, Briel JW. Transanal advancement flap repair of transsphincteric fistulas. Dis Colon Rectum 1999;42:1419–23.

    Article  PubMed  CAS  Google Scholar 

  2. Zimmerman DD, Briel JW, Gosselink MP, Schouten WR. Anocutaneous advancement flap repair of transsphincteric fistulas. Dis Colon Rectum 2001;44:1474–80.

    Article  PubMed  CAS  Google Scholar 

  3. Buchanan GN, Bartram CI, Phillips RK, et al. Efficacy of fibrin sealant in the management of complex anal fistula. Dis Colon Rectum 2003;46:1167–74.

    Article  PubMed  Google Scholar 

  4. Loungnarath R, Dietz DW, Mutch MG, Birnbaum EH, Kodner IJ, Fleshman JW. Fibrin glue treatment of complex anal fistulas has low success rate. Dis Colon Rectum 2004;47:432–6.

    Article  PubMed  Google Scholar 

  5. Cintron JR, Park JJ, Orsay CP, et al. Repair of fistulas-in-ano using fibrin adhesive: long-term follow-up. Dis Colon Rectum 2000;43:944–50.

    Article  PubMed  CAS  Google Scholar 

  6. Patrlj L, Kocman B, Martinac M, et al. Fibrin glue antibiotic mixture in the treatment of anal fistulae: experience with 69 cases. Dig Surg 2000;17:77–80.

    Article  PubMed  CAS  Google Scholar 

  7. Sentovich SM. Fibrin glue for all anal fistulas. J Gastrointest Surg 2001;5:158–61.

    Article  PubMed  CAS  Google Scholar 

  8. Chan KM, Lau CW, Lai KK, et al. Preliminary results of using a commercial fibrin sealant in the treatment of fistula-in-ano. J R Coll Surg Edinb 2002;47:407–10.

    PubMed  CAS  Google Scholar 

  9. Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum 2006;49:371–6.

    Article  PubMed  Google Scholar 

  10. O’Connor LM, Champagne BJ, Ferguson MA, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of Crohn’s anorectal fistulas. Dis Colon Rectum 2006;49:1569–73.

    Article  PubMed  Google Scholar 

  11. Champagne BJ, O’Connor LM, Ferguson M, Orangio GR, Schertzer ME, Armstrong DN. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum 2006;49:1817–21.

    Article  PubMed  Google Scholar 

  12. Ellis CN. Bioprosthetic plugs for complex anal fistulas: an early experience. J Surg Ed 2007;64:36–40.

    Article  Google Scholar 

  13. Badylak SF. Small intestinal submucosa (SIS): a biomaterial conducive to smart tissue remodeling. In: Bell E, ed. Tissue engineering: current perspectives. Cambridge: Burkhauser Publishers, 1993:179–89.

    Google Scholar 

  14. Badylak SF, Kropp B, McPherson T, Liang H, Snyder PW. Small intestinal submucosa: a rapidly resorbed bioscaffold for augmentation cystoplasty in a dog model. Tissue Eng 1998;4:379–87.

    Article  PubMed  CAS  Google Scholar 

  15. Badylak SF. The extracellular matrix as a scaffold for tissue reconstruction. Semin Cell Dev Biol 2002;13:377–83.

    Article  PubMed  CAS  Google Scholar 

  16. Badylak SF, Kokini K, Tullius B, Simmons-Byrd A, Morff R. Morphologic study of small intestinal submucosa as a body wall repair device. J Surg Res 2002;103:190–202.

    Article  PubMed  Google Scholar 

  17. Whiteford MH, Kilkenny J 3rd, Hyman N, et al. The Standards Practice Task Force; The American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of perianal abscess and fistula-in-ano (revised). Dis Colon Rectum 2005;48:1337–42.

    Article  PubMed  Google Scholar 

  18. Ueno T, Pickett LC, de la Fuente SG, Lawson DC, Pappas TN. Clinical application of porcine small intestinal submucosa in the management of infected or potentially contaminated abdominal defects. J Gastrointest Surg 2004;8:109–12.

    Article  PubMed  Google Scholar 

  19. Franklin ME Jr, Gonzalez JJ Jr, Glass JL. Use of porcine small intestinal submucosa as a prosthetic device for laparoscopic repair of hernias in contaminated fields: 2-year follow-up. Hernia 2004;8:186–9.

    PubMed  Google Scholar 

  20. Helton WS, Fisichella PM, Berger R, Horgan S, Espat NJ, Abcarian H. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg 2005;140:549–62.

    Article  PubMed  Google Scholar 

  21. Zmora O, Mizrahi N, Rotholtz N, et al. Fibrin glue sealing in the treatment of perineal fistulas. Dis Colon Rectum 2003;46:584–9.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Mount Sinai Medical Center, 5 E. 98th St., Box 1273, New York, NY, 10029, USA

    Alex J. Ky M.D., Patricia Sylla M.D., Randolph Steinhagen M.D., Emily Steinhagen B.A., Sergei Khaitov M.D. & Erin K. Ly B.A.

Authors
  1. Alex J. Ky M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Patricia Sylla M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Randolph Steinhagen M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Emily Steinhagen B.A.
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sergei Khaitov M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Erin K. Ly B.A.
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Alex J. Ky M.D..

Additional information

Participant of the Surgisis® (AFP™) Consensus Committee. All participants received reimbursement for expenses through Cook Medical Incorporated (Bloomington, IN), and everyone received an honorarium for dedicating his or her weekend to the task.

About this article

Cite this article

Ky, A.J., Sylla, P., Steinhagen, R. et al. Collagen Fistula Plug for the Treatment of Anal Fistulas. Dis Colon Rectum 51, 838–843 (2008). https://doi.org/10.1007/s10350-007-9191-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10350-007-9191-2

Key words

Search

Navigation