Biomaterials in the Treatment of Anal Fistula: Hope or Hype?

Daniele Scoglio; Avery S. Walker; Alessandro Fichera

doi:10.1055/s-0034-1394156

Clinics in Colon and Rectal Surgery, Table of Contents

Clin Colon Rectal Surg 2014; 27(04): 172-181
DOI: 10.1055/s-0034-1394156

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Biomaterials in the Treatment of Anal Fistula: Hope or Hype?

Daniele Scoglio

¹Department of Surgery, University of Washington Medical Center, Seattle, Washington

,

Avery S. Walker

²Department of Surgery, Madigan Army Medical Center, Fort Lewis, Washington

,

Alessandro Fichera

¹Department of Surgery, University of Washington Medical Center, Seattle, Washington

› Author Affiliations

Abstract

Anal fistula (AF) presents a chronic problem for patients and colorectal surgeons alike. Surgical treatment may result in impairment of continence and long-term risk of recurrence. Treatment options for AFs vary according to their location and complexity. The ideal approach should result in low recurrence rates and minimal impact on continence. New technical approaches involving biologically derived products such as biological mesh, fibrin glue, fistula plug, and stem cells have been applied in the treatment of AF to improve outcomes and decrease recurrence rates and the risk of fecal incontinence. In this review, we will highlight the current evidence and describe our personal experience with these novel approaches.

Keywords

anal fistula - biologic mesh - fibrin glue - fistula plug - bio-LIFT - stem cells

Full Text

References

References
1 Zanotti C, Martinez-Puente C, Pascual I, Pascual M, Herreros D, García-Olmo D. An assessment of the incidence of fistula-in-ano in four countries of the European Union. Int J Colorectal Dis 2007; 22 (12) 1459-1462
2 Marks CG, Ritchie JK. Anal fistulas at St Mark's Hospital. Br J Surg 1977; 64 (2) 84-91
3 Parks AG. Pathogenesis and treatment of fistuila-in-ano. BMJ 1961; 1 (5224) 463-469
4 Abbas MA, Lemus-Rangel R, Hamadani A. Long-term outcome of endorectal advancement flap for complex anorectal fistulae. Am Surg 2008; 74 (10) 921-924
5 Hamadani A, Haigh PI, Liu IL, Abbas MA. Who is at risk for developing chronic anal fistula or recurrent anal sepsis after initial perianal abscess?. Dis Colon Rectum 2009; 52 (2) 217-221
6 Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg 1976; 63 (1) 1-12
7 Ky AJ, Sylla P, Steinhagen R, Steinhagen E, Khaitov S, Ly EK. Collagen fistula plug for the treatment of anal fistulas. Dis Colon Rectum 2008; 51 (6) 838-843
8 Hanley PH. Conservative surgical correction of horseshoe abscess and fistula. Dis Colon Rectum 1965; 8 (5) 364-368
9 Thompson Jr JE, Bennion RS, Hilliard G. Adjustable seton in the management of complex anal fistula. Surg Gynecol Obstet 1989; 169 (6) 551-552
10 Elting AW. The treatment of fistula in ano with special reference to the Whitehead operation. Ann Surg 1912; 56 (5) 744-752
11 Rizzo JA, Naig AL, Johnson EK. Anorectal abscess and fistula-in-ano: evidence-based management. Surg Clin North Am 2010; 90 (1) 45-68
12 Ho KS, Tsang C, Seow-Choen F , et al. Prospective randomised trial comparing ayurvedic cutting seton and fistulotomy for low fistula-in-ano. Tech Coloproctol 2001; 5 (3) 137-141
13 Ommer A, Herold A, Joos A, Schmidt C, Weyand G, Bussen D. Gore BioA Fistula Plug in the treatment of high anal fistulas—initial results from a German multicenter-study. Ger Med Sci 2012; 10: Doc13
14 Shawki S, Wexner SD. Idiopathic fistula-in-ano. World J Gastroenterol 2011; 17 (28) 3277-3285
15 Whiteford MH, Kilkenny III J, Hyman N , et al; Standards Practice Task Force. 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 (7) 1337-1342
16 Deeba S, Aziz O, Sains PS, Darzi A. Fistula-in-ano: advances in treatment. Am J Surg 2008; 196 (1) 95-99
17 van Koperen PJ, Wind J, Bemelman WA, Bakx R, Reitsma JB, Slors JF. Long-term functional outcome and risk factors for recurrence after surgical treatment for low and high perianal fistulas of cryptoglandular origin. Dis Colon Rectum 2008; 51 (10) 1475-1481
18 van Koperen PJ, Wind J, Bemelman WA, Slors JF. Fibrin glue and transanal rectal advancement flap for high transsphincteric perianal fistulas; is there any advantage?. Int J Colorectal Dis 2008; 23 (7) 697-701
19 Golub RW, Wise Jr WE, Kerner BA, Khanduja KS, Aguilar PS. Endorectal mucosal advancement flap: the preferred method for complex cryptoglandular fistula-in-ano. J Gastrointest Surg 1997; 1 (5) 487-491
20 Uribe N, Millán M, Minguez M , et al. Clinical and manometric results of endorectal advancement flaps for complex anal fistula. Int J Colorectal Dis 2007; 22 (3) 259-264
21 Tyler KM, Aarons CB, Sentovich SM. Successful sphincter-sparing surgery for all anal fistulas. Dis Colon Rectum 2007; 50 (10) 1535-1539
22 van der Hagen SJ, Baeten CG, Soeters PB, Beets-Tan RG, Russel MG, van Gemert WG. Staged mucosal advancement flap for the treatment of complex anal fistulas: pretreatment with noncutting Setons and in case of recurrent multiple abscesses a diverting stoma. Colorectal Dis 2005; 7 (5) 513-518
23 Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K. Total anal sphincter saving technique for fistula-in-ano; the ligation of intersphincteric fistula tract. J Med Assoc Thai 2007; 90 (3) 581-586
24 Aboulian A, Kaji AH, Kumar RR. Early result of ligation of the intersphincteric fistula tract for fistula-in-ano. Dis Colon Rectum 2011; 54 (3) 289-292
25 Ooi K, Skinner I, Croxford M, Faragher I, McLaughlin S. Managing fistula-in-ano with ligation of the intersphincteric fistula tract procedure: the Western Hospital experience. Colorectal Dis 2012; 14 (5) 599-603
26 Shanwani A, Nor AM, Amri N. Ligation of the intersphincteric fistula tract (LIFT): a sphincter-saving technique for fistula-in-ano. Dis Colon Rectum 2010; 53 (1) 39-42
27 Tan KK, Tan IJ, Lim FS, Koh DC, Tsang CB. The anatomy of failures following the ligation of intersphincteric tract technique for anal fistula: a review of 93 patients over 4 years. Dis Colon Rectum 2011; 54 (11) 1368-1372
28 Bleier JI, Moloo H, Goldberg SM. Ligation of the intersphincteric fistula tract: an effective new technique for complex fistulas. Dis Colon Rectum 2010; 53 (1) 43-46
29 Hjortrup A, Moesgaard F, Kjaergård J. Fibrin adhesive in the treatment of perineal fistulas. Dis Colon Rectum 1991; 34 (9) 752-754
30 Hammond TM, Grahn MF, Lunniss PJ. Fibrin glue in the management of anal fistulae. Colorectal Dis 2004; 6 (5) 308-319
31 Cintron JR, Park JJ, Orsay CP, Pearl RK, Nelson RL, Abcarian H. Repair of fistulas-in-ano using autologous fibrin tissue adhesive. Dis Colon Rectum 1999; 42 (5) 607-613
32 Venkatesh KS, Ramanujam P. Fibrin glue application in the treatment of recurrent anorectal fistulas. Dis Colon Rectum 1999; 42 (9) 1136-1139
33 Buchanan GN, Bartram CI, Phillips RK , et al. Efficacy of fibrin sealant in the management of complex anal fistula: a prospective trial. Dis Colon Rectum 2003; 46 (9) 1167-1174
34 Lindsey I, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ, George BD. A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula. Dis Colon Rectum 2002; 45 (12) 1608-1615
35 Zmora O, Mizrahi N, Rotholtz N , et al. Fibrin glue sealing in the treatment of perineal fistulas. Dis Colon Rectum 2003; 46 (5) 584-589
36 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 (7) 944-949 , discussion 949–950
37 Gisbertz SS, Sosef MN, Festen S, Gerhards MF. Treatment of fistulas in ano with fibrin glue. Dig Surg 2005; 22 (1-2) 91-94
38 de Parades V, Far HS, Etienney I, Zeitoun JD, Atienza P, Bauer P. Seton drainage and fibrin glue injection for complex anal fistulas. Colorectal Dis 2010; 12 (5) 459-463
39 Dietz DW. Role of fibrin glue in the management of simple and complex fistula in ano. J Gastrointest Surg 2006; 10 (5) 631-632
40 Adams T, Yang J, Kondylis LA, Kondylis PD. Long-term outlook after successful fibrin glue ablation of cryptoglandular transsphincteric fistula-in-ano. Dis Colon Rectum 2008; 51 (10) 1488-1490
41 Park JJ, Cintron JR, Orsay CP , et al. Repair of chronic anorectal fistulae using commercial fibrin sealant. Arch Surg 2000; 135 (2) 166-169
42 Sentovich SM. Fibrin glue for all anal fistulas. J Gastrointest Surg 2001; 5 (2) 158-161
43 Zmora O, Neufeld D, Ziv Y , et al. Prospective, multicenter evaluation of highly concentrated fibrin glue in the treatment of complex cryptogenic perianal fistulas. Dis Colon Rectum 2005; 48 (12) 2167-2172
44 Sehgal R, Koltun WA. Fibrin glue for the treatment of perineal fistulous Crohn's disease. Gastroenterology 2010; 138 (7) 2216-2219
45 Swinscoe MT, Ventakasubramaniam AK, Jayne DG. Fibrin glue for fistula-in-ano: the evidence reviewed. Tech Coloproctol 2005; 9 (2) 89-94
46 Ellis CN, Clark S. Fibrin glue as an adjunct to flap repair of anal fistulas: a randomized, controlled study. Dis Colon Rectum 2006; 49 (11) 1736-1740
47 Singer M, Cintron J, Nelson R , et al. Treatment of fistulas-in-ano with fibrin sealant in combination with intra-adhesive antibiotics and/or surgical closure of the internal fistula opening. Dis Colon Rectum 2005; 48 (4) 799-808
48 Sentovich SM. Fibrin glue for anal fistulas: long-term results. Dis Colon Rectum 2003; 46 (4) 498-502
49 de la Portilla F, Rada R, León E, Cisneros N, Maldonado VH, Espinosa E. Evaluation of the use of BioGlue in the treatment of high anal fistulas: preliminary results of a pilot study. Dis Colon Rectum 2007; 50 (2) 218-222
50 Abbas MA, Tejirian T. Bioglue for the treatment of anal fistula is associated with acute anal sepsis. Dis Colon Rectum 2008; 51 (7) 1155 , author reply 1156
51 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 (1) 77-80
52 Maralcan G, Başkonuş I, Aybasti N, Gökalp A. The use of fibrin glue in the treatment of fistula-in-ano: a prospective study. Surg Today 2006; 36 (2) 166-170
53 Mishra A, Shah S, Nar AS, Bawa A. The role of fibrin glue in the treatment of high and low fistulas in ano. J Clin Diagn Res 2013; 7 (5) 876-879
54 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 (4) 432-436
55 Alexander SM, Mitalas LE, Gosselink MP, Oom DM, Zimmerman DD, Schouten WR. Obliteration of the fistulous tract with BioGlue adversely affects the outcome of transanal advancement flap repair. Tech Coloproctol 2008; 12 (3) 225-228
56 Mizrahi N, Wexner SD, Zmora O , et al. Endorectal advancement flap: are there predictors of failure?. Dis Colon Rectum 2002; 45 (12) 1616-1621
57 Witte ME, Klaase JM, Gerritsen JJ, Kummer EW. Fibrin glue treatment for simple and complex anal fistulas. Hepatogastroenterology 2007; 54 (76) 1071-1073
58 Robb BW, Nussbaum MN, Vogler SA, Sklow B . Early experience using porcine small intestinal submucosa to repair fistulas-in-ano. In: Annual Meeting of the American Society of Colon and Rectal Surgeons. Seattle, WA; 2006
59 Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum 2006; 49 (3) 371-376
60 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 (1) 109-112
61 Hammond TM, Lunniss PJ. Novel biomaterials in the management of anal fistulas. Dis Colon Rectum 2006; 49 (9) 1463-1464 , author reply 1464–1465
62 Christoforidis D, Etzioni DA, Goldberg SM, Madoff RD, Mellgren A. Treatment of complex anal fistulas with the collagen fistula plug. Dis Colon Rectum 2008; 51 (10) 1482-1487
63 El-Gazzaz G, Zutshi M, Hull T. A retrospective review of chronic anal fistulae treated by anal fistulae plug. Colorectal Dis 2010; 12 (5) 442-447
64 The Surgisis AFP anal fistula plug: report of a consensus conference. Colorectal Dis 2008; 10 (1) 17-20
65 Sonoda T, Hull T, Piedmonte MR, Fazio VW. Outcomes of primary repair of anorectal and rectovaginal fistulas using the endorectal advancement flap. Dis Colon Rectum 2002; 45 (12) 1622-1628
66 O'Connor L, 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 (10) 1569-1573
67 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 (12) 1817-1821
68 Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendáriz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg 2009; 96 (6) 608-612
69 van Koperen PJ, Bemelman WA, Gerhards MF , et al. The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial. Dis Colon Rectum 2011; 54 (4) 387-393
70 Garg P, Song J, Bhatia A, Kalia H, Menon GR. The efficacy of anal fistula plug in fistula-in-ano: a systematic review. Colorectal Dis 2010; 12 (10) 965-970
71 Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery 2010; 147 (1) 72-78
72 de Parades V, Zeitoun JD, Atienza P. Cryptoglandular anal fistula. J Vis Surg 2010; 147 (4) e203-e215
73 Han JG, Wang ZJ, Zhao BC , et al. Long-term outcomes of human acellular dermal matrix plug in closure of complex anal fistulas with a single tract. Dis Colon Rectum 2011; 54 (11) 1412-1418
74 A ba‐bai‐ke‐re, MM Wen H, Huang HG. , et al. Randomized controlled trial of minimally invasive surgery using acellular dermal matrix for complex anorectal fistula. World J Gastroenterol 2010; 16 (26) 3279-3286
75 Safar B, Jobanputra S, Sands D, Weiss EG, Nogueras JJ, Wexner SD. Anal fistula plug: initial experience and outcomes. Dis Colon Rectum 2009; 52 (2) 248-252
76 Heydari A, Attinà GM, Merolla E, Piccoli M, Fazlalizadeh R, Melotti G. Bioabsorbable synthetic plug in the treatment of anal fistulas. Dis Colon Rectum 2013; 56 (6) 774-779
77 Buchberg B, Masoomi H, Choi J, Bergman H, Mills S, Stamos MJ. A tale of two (anal fistula) plugs: is there a difference in short-term outcomes?. Am Surg 2010; 76 (10) 1150-1153
78 de la Portilla F, Rada R, Jiménez-Rodríguez R, Díaz-Pavón JM, Sánchez-Gil JM. Evaluation of a new synthetic plug in the treatment of anal fistulas: results of a pilot study. Dis Colon Rectum 2011; 54 (11) 1419-1422
79 Ratto C, Litta F, Parello A, Donisi L, Zaccone G, De Simone V. Gore Bio-A® Fistula Plug: a new sphincter-sparing procedure for complex anal fistula. Colorectal Dis 2012; 14 (5) e264-e269
80 Liu WY, Aboulian A, Kaji AH, Kumar RR. Long-term results of ligation of intersphincteric fistula tract (LIFT) for fistula-in-ano. Dis Colon Rectum 2013; 56 (3) 343-347
81 Abcarian AM, Estrada JJ, Park J , et al. Ligation of intersphincteric fistula tract: early results of a pilot study. Dis Colon Rectum 2012; 55 (7) 778-782
82 Ellis CN. Outcomes after repair of rectovaginal fistulas using bioprosthetics. Dis Colon Rectum 2008; 51 (7) 1084-1088
83 Tan KK, Lee PJ. Early experience of reinforcing the ligation of the intersphincteric fistula tract procedure with a bioprosthetic graft (BioLIFT) for anal fistula. ANZ J Surg 2014; 84 (4) 280-283
84 Chew MH, Lee PJ, Koh CE, Chew HE. Appraisal of the LIFT and BIOLIFT procedure: initial experience and short-term outcomes of 33 consecutive patients. Int J Colorectal Dis 2013; 28 (11) 1489-1496
85 Han JG, Yi BQ, Wang ZJ , et al. Ligation of the intersphincteric fistula tract plus a bioprosthetic anal fistula plug (LIFT-Plug): a new technique for fistula-in-ano. Colorectal Dis 2013; 15 (5) 582-586
86 Mizuno H, Zuk PA, Zhu M, Lorenz HP, Benhaim P, Hedrick MH. Myogenic differentiation by human processed lipoaspirate cells. Plast Reconstr Surg 2002; 109 (1) 199-209 , discussion 210–211
87 Garcia-Olmo D, Herreros D, Pascual I , et al. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum 2009; 52 (1) 79-86
88 Guadalajara H, Herreros D, De-La-Quintana P, Trebol J, Garcia-Arranz M, Garcia-Olmo D. Long-term follow-up of patients undergoing adipose-derived adult stem cell administration to treat complex perianal fistulas. Int J Colorectal Dis 2012; 27 (5) 595-600
89 Ciccocioppo R, Bernardo ME, Sgarella A , et al. Autologous bone marrow-derived mesenchymal stromal cells in the treatment of fistulising Crohn's disease. Gut 2011; 60 (6) 788-798
90 Himpson RC, Cohen CR, Sibbons P, Phillips RK. An experimentally successful new sphincter-conserving treatment for anal fistula. Dis Colon Rectum 2009; 52 (4) 602-608
91 Cirocchi R, Trastulli S, Morelli U , et al. The treatment of anal fistulas with biologically derived products: is innovation better than conventional surgical treatment? An update. Tech Coloproctol 2013; 17 (3) 259-273
92 Ellis CN. Bioprosthetic plugs for complex anal fistulas: an early experience. J Surg Educ 2007; 64 (1) 36-40