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Original article doi:10.1111/j.1463-1318.2008.01627.x Efficacy of the anal fistula plug in complex anorectal fistulae D. K. Thekkinkattil*, I. Botterill*, N. S. Ambrose*, L. Lundby†, P. M. Sagar*, S. Buntzen† and P. J. Finan* *John Goligher Colorectal Unit, General Infirmary at Leeds, Leeds Teaching Hospitals NHS Trust, Leeds, UK and †Department of Surgery, Aarhus University Hospital, THG, Aarhus, Denmark Received 19 February 2008; accepted 22 April 2008 Abstract Objective The treatment of complex anorectal and rectovaginal fistulae remains a difficult problem. The options are fistulotomy, setons, fibrin glue and a variety of flap procedures. Recently, there have been several reports of a new plug; the Surgisis� AFP� plug. Reports from various centres do not give consistent results. The aim of this study was to assess the efficacy of the Surgisis� AFP� fistula plug in a wide spectrum of patients with anorectal, rectovaginal and pouch vaginal fistulae. Method Between March 2006 and September 2007, patients with a variety of anal fistulae were selected for fistula plug insertion in the coloproctology units at Leeds, UK, and Aarhus, Denmark. Demographic and fistulae details were obtained. Postoperatively, all patients had a course of oral antibiotics. Results Forty-three patients with a median age of 45 (range 18–65) years underwent a total of 45 procedures. Seventy-five per cent (n = 32) had a fistula secondary to cryptoglandular abscess. Median follow up was 47 (range 12–77) weeks. The success rate for complete healing was 44%. Dislodgement caused failure on 10 (22%) occasions. Conclusion Our study shows a moderate success rate for treatment with fistula plugs. The complex nature of the fistulae selected may be the reason for the low success rate. Keywords Anal fistula plug, complex anal fistula, Crohn’s disease Introduction Fistula in ano is a common surgical condition with a prevalence rate of 8.6 cases per 100 000 [1]. The incidence is higher in male patients with a male-to-female ratio of 1.8:1 [1]. The reported incidence in England is 18.4 per 100 000 ⁄ year [2]. The principles of treatment, remaining the same over many years, are to heal the fistula without compromising continence whilst achieving a low recurrence rate. Unfortunately none of the com- mon treatments is free of complications or recurrence. The spectrum of surgical treatment for fistula in ano ranges from the traditional practice of fistulotomy to more complex procedures such as re-routing of the fistula tract or advancement flaps [3–6] depending on the severity and site of fistula. The treatment for complex fistulae that involve a greater proportion of anal sphincter complex, horseshoe fistulae, rectovaginal or pouch vaginal fistulae is technically demanding. They are asso- ciated with higher rate of recurrence and increased incidence of incontinence [7,8]. Similarly, the surgical treatment for fistulae associated with Crohn’s disease is difficult as well as controversial. About a third of patients with Crohn’s disease develop an anal or rectovaginal fistula during their life [9]. Various types of closure techniques and flaps have been tried with healing rates ranging from 25% to 86% [9]. Incontinence following flap techniques can also be a problem [10,11]. Some of the conventional procedures are not feasible for the management of recto vaginal, pouch vaginal and pouch cutaneous fistulae. There is limited literature on this topic [12]. The treatment options again are variable with use of vaginal flaps, fibrin glue, etc. The high failure rate is sometimes attributed to the connection between the high-pressure contaminated cavity (rectum) and low- pressure vaginal cavity. In 1992, Hjortrup et al. [13] reported the use of fibrin glue for sealing the track aiming to minimize disruption to the anal sphincter complex and thus maintain continence. This technique is simple, repeatable and does not involve Correspondence to: Mr Paul J. Finan, MD, FRCS, Hon. FRCS (Glasg.), John Goligher Colorectal Unit, General Infirmary at Leeds, Leeds LS1 3EX, UK. E-mail: paul.finan@leedsth.nhs.uk This paper was presented as a poster at the European Society of Coloproctology in Malta, September 2007. 584 � 2009 The Authors. Journal Compilation � 2009 The Association of Coloproctology of Great Britain and Ireland. Colorectal Disease, 11, 584–587 division of any portion of the sphincter complex; different studies have reported a highly variable success rate ranging from 10% to 85% [14,15]. Armstrong has developed a new biologic anal fistula plug, which can be sutured into the internal opening to close the fistulous tract [16]. The plug, Surgisis� AFP� (Cook Biotech Inc., West Lafayette, Indiana, USA), is a bioabsorbable xenograft, made of lyophilized porcine intestinal submucosa. The initial series reported a healing rate of 87% when compared with a 40% success rate with fibrin glue. These initial results were sustained over a follow up of 2-year period [17]. Similarly, a good healing rate of 83% was reported with fistula plug insertion in patients with fistulae complicating Crohn’s disease [18]. Similar high healing rates have not been reported from other centres [19,20]. Aim The aim of this prospective study was to assess the efficacy of the Surgisis� AFP� anal fistula plug in the treatment of a wide spectrum of patients with complex anorectal, rectovaginal and pouch vaginal fistulae. Method This study was carried out in the coloproctology units at The Leeds Teaching Hospitals, Leeds, UK, and Aarhus University Hospital, Aarhus, Denmark. Between March 2006 and September 2007, patients with recurrent anorectal fistulae were offered treatment with the fistula plug (Surgisis� AFP� Anal Fistula Plug). All these patients had a variety of complex fistulae such as recurrent high trans-sphincteric or horseshoe or recto ⁄ ano vaginal or pouch vaginal or pouch cutaneous fistulae. Simple low trans-sphincteric fistulae were not included for treatment by the fistula plug. Patients All patients had failed initial surgical treatment prior to the insertion of the fistula plug. Informed consent was obtained. In addition to demographic details, a history of previous fistula surgery, inflammatory bowel disease and type of fistulae was noted. Acute sepsis was treated with incision and drainage, and a loose seton was often employed prior to the definitive procedure. Procedure Most of the patients with cryptoglandular fistulae under- went the procedure under general anaesthetic in the lithotomy position. The prone jack-knife position was used for patients with rectovaginal and pouch vaginal fistulae. At the University Hospital of Aarhus, the anterior anal fistulae were also treated in the prone jack-knife position. The procedures were carried out by six different colorectal surgeons. Patients had an enema to clear the bowels on the day of surgery. Prior to insertion of the plug, none of the fistulous tracts was curetted but was irrigated with saline orhydrogenperoxide to remove anydebris. The fistula plug was inserted from the internal opening and fixed at the internal opening with Vicryl O stitches as described before, with special attention being made to ensure that the external opening was not completely occluded [17]. In some early cases, the plug was fixed also at the external opening but this practice was abandoned in both centres later in the series. The rectal mucosa was closed over the fistula plug at the internal opening along with a deep suture through the internal sphincter. Post- operatively patients received a course of oral cephradine and metronidazole as well as fybogel and lactulose for a week. None of the patients was given any topical antibi- otics. Patients were advised to avoid strenuous exercises. None of these patients was on any special dietary restric- tions. Follow up In Leeds, the patients were followed up at 6 weeks in the clinic. The protocol in Denmark was an initial 2-week appointment followed by a subsequent 3-month follow up. Patients with a successful outcome were discharged at this point but where healing was not complete, treatment was continued. Further examination under anaesthetic was carried out only where there was a suspicion of dislodgement or infection. Patients discharged at 3 months were further contacted at the time of this analysis of data. Fistulae were considered healed when patients were completely asymptomatic, with a healed external open- ing. There was no policy in place during this study for magnetic resonance imaging in the postoperative period. Statistical analysis The data was analysed by SPSS 14.0 for Windows (SPSS Inc., Chicago, IL, USA). Kruskal–Wallis test was used to compare nonparametric variables whereas Fisher’s exact test was used in the analysis of categorical data. A P-value of < 0.05 was deemed to be statistically significant. Results Forty-three patientswith amedian age of 45 (range 18–65) years were included. There were 16 men and 27 women. D. K. Thekkinkattil et al. Anal fistula plug efficacy in complex anorectal fistulae � 2009 The Authors. Journal Compilation � 2009 The Association of Coloproctology of Great Britain and Ireland. Colorectal Disease, 11, 584–587 585 The majority of patients had a fistula secondary to a cryptoglandular abscess (Table 1). Twenty-five patients had their procedures at Leeds Teaching Hospitals, and the remaining 18 patients under- went the procedure at Aarhus University Hospital. Two patients underwent the procedure twice, and one patient had two fistulae treated with fistula plug making a total of 45 procedures in 43 patients. Themedian follow upwas 47 (range 12–77) weeks. Table 2 describes the anatomical type of fistulae with the outcome at follow up. Only 44% (n = 20) of fistulous tracks healed completely. Dislodge- ment of the fistula plug was thought to be the cause for failure on 10 (22%) occasions in the early postoperative period. All the failures in patients from Leeds happened in the first 6 weeks. Table 3 demonstrates the comparison of healing rate between cryptoglandular and those associated with inflammatory bowel disease. The differences were not statistically significant (P = 0.294, Fisher’s exact test). Similarly, the healing rate according to the type of fistulae (transsphincteric vs horseshoe vs vaginal) was also not significantly different. (P = 0.224, Kruskal–Wallis test). Table 4 shows the healing rate in patients with andwithout fistulation into the vagina. Although four of five patients withmultiple fistulous tracks failed to heal, this observation failed to reach statistical significance (Table 5; P = 0.362, Fisher’s exact test). Discussion The surgical treatment of complex fistulae remains a challenge and a variety of techniques have been used in an attempt to achieve a cure, e.g. cutting and loose setons, staged fistulotomy and rectal or anocutaneous advance- ment flaps [7,10,21]. The incidence of faecal incontinence ranges from 0% to 63% with cutting setons and up to 35% for advancement flaps [10,22–24]. Hence sphincter spar- ing procedures like fibrin sealants gained in popularity in an effort to reduce the incidence of postoperative inconti- nence. Fibrin glue has the advantage of being simple, repeatable and does not interfere with any future proce- dure. The initial results were promising but later results were disappointing [25]. The same strategy has, however, led to the development of the fistula plug that is bioabsorbable and may have an inherent resistance to infection [16]. The initial series reported an excellent rate of healing for complex fistulae with the plug [16–18] but others have failed to reproduce these results, having a similar success rate (41%) to the present study [19]. This prospective two-centre study failed to reproduce the excellent success rates for the fistula plug reported by Armstrong [16–18]. In line with the van Koperen’s study [19], which showed the main cause of failure to be early dislodgement of the plug in the postoperative period, we also found this to account for 22%. The disparity in the results reported from various centres may well be due to the heterogeneity of the fistulae. In our series for example, 20% of patients had a recto ⁄ ano vaginal or pouch vaginal fistula, the treatment of which is usually difficult. Similarly, Table 1 Fistulae according to aetiology. Aetiology Number (%) Cryptoglandular 32 (75) Crohn’s disease 6 (14) Ulcerative colitis 1 (2) Pouch vaginal fistula 3 (7) Other 1 (2) Table 2 Anatomical classification and treatment outcome. Type of fistula Healed (n = 20) Nonhealed (n = 25) P-value* Trans-sphincteric with radial tracts (n = 29) 16 12 0.224 Supra levator (n = 2) 0 2 Horseshoe (n = 5) 2 4 Rectovaginal (n = 7) 1 5 Pouch vaginal (n = 3) 1 2 *Kruskal–Wallis test. Table 3 Outcome according to aetiology. Type of fistula Healed Nonhealed P-value* Cryptoglandular 17 16 0.294 Inflammatory bowel disease 3 8 *Fisher’s exact test. Table 4 Healing rate according to vaginal involvement. Healed Nonhealed P-value* Anorectal fistula without vaginal involvement 18 18 0.260 Anorectal fistulae with vaginal involvement 2 7 *Fisher’s exact test. Table 5 Healing according to number of fistulous tracks. Number of tracks Healed Nonhealed P-value* Single 19 21 0.362 Multiple 1 4 *Fisher’s exact test. Anal fistula plug efficacy in complex anorectal fistulae D. K. Thekkinkattil et al. 586 � 2009 The Authors. Journal Compilation � 2009 The Association of Coloproctology of Great Britain and Ireland. Colorectal Disease, 11, 584–587 all patients in our series had undergone various surgical procedures before the insertion of the plug. Sentovich et al. [26] suggested that the degree of scarring and fibrosis from previous procedures might contribute to poor healing of fistulae following fibrin glue treatment. It is difficult to comment whether a similar observation can be made following treatment with the fistula plug, as a larger patient group would be needed. Scarring and fibrosis from previous surgery and the short length of fistulous tracts involving the vagina might have contrib- uted to the early dislodgement in our series. The results of this study should be interpreted with some caution, as the number of patients in each subgroup is small and the median duration of follow up was just under 1 year. Like van Koperen et al., the patients in our series were not on any dietary restrictions after fistula plug insertion. Further studies are needed to determine whether this has any role in preventing failure. The cost of the plug ($1000) is considerable and it is therefore important to assess its effectiveness by prospec- tive randomized trials with longer follow up. Financial support None. References 1 Nwaejike N, Gilliland R. Surgery for fistula-in-ano: an audit of practise of colorectal and general surgeons. Colorectal Dis 2007; 9: 749–53. 2 Zanotti C, Martinez-Puente C, Pascual I, Pascual M, Herreros D, Garcia-Olmo D. An assessment of the inci- dence of fistula-in-ano in four countries of the European Union. 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Fibrin glue for all anal fistulas. J Gastrointest Surg 2001; 5: 158–61. D. K. Thekkinkattil et al. Anal fistula plug efficacy in complex anorectal fistulae � 2009 The Authors. Journal Compilation � 2009 The Association of Coloproctology of Great Britain and Ireland. Colorectal Disease, 11, 584–587 587