Int J Colorectal DisDOI 10.1007/s00384-010-1066-7 Porcine dermal collagen matrix injection may enhance flaprepair surgery for complex anal fistula Pierpaolo Sileri & Luana Franceschilli &Giovanna Del Vecchio Blanco & Vito M. Stolfi &Giulio P. Angelucci & Achille L. Gaspari Accepted: 4 October 2010# Springer-Verlag 2010 impact on incontinence [, ]. On the other hand, surgical Introduction The use of biomaterials to treat anal fistula has treatments for high and complex fistulas may results in drawn great interest. More recently, a porcine dermal matrix variable degree of anal sphincter apparatus impairment.
injection has been proposed as infill biomaterial to treat Various alternative surgical options have been proposed such as flap repair, fibrin glue injection, seton drainage and Methods We propose a novel approach consisting in non- fistula track plug insertion with variable success rates cutting seton positioning followed by flap repair associated Currently, the transanal rectal advancement flap represents with dermal matrix injection into the fistula tracts after the most effective treatment for complex anal fistulas allowing the closure of the internal opening with successful Results We report our experience with this two-staged rates, in some series, above 90%. However commonly, procedure on 11 consecutive patients with recurrent high recurrence rate is approximately 30%, a rate that leaves trans-sphincteric fistulas with a minimum follow-up of Over the last two decades, the use of biomaterials to treat Conclusions In our experience, this two-stage approach anal fistula has drawn great interest. Among these, fibrin glue injection has been proposed to obliterate the fistulatract/s, but initial enthusiasms have been tempered by high Keywords Permacol . Complex anal fistula . Flap repair rates of recurrences [–, , ]. Several authors havetried a combination of fibrin glue and flap repair in order toenhance its success rates [, . Results have been disappointing, showing worse outcomes after the combina-tion of the two compared to flap repair alone []. Reasons The management of fistula-in-ano aims minimizing recur- why fibrin glue addition is ineffective or even worse are rences while maintaining continence. Low fistulas, where unclear. A possible explanation can be that the closure of the tract is submucosal, intersphincteric, or located in the the fistula tract with the glue leads to a situation where lower third of the external anal sphincter are usually treated insufficient drainage from the primary and eventual by fistulotomy with low recurrence rates and relatively little secondary fistula tract occurs More recently, a porcinedermal matrix injection, named Permacol injection (Covi-dien plc, Dublin, Ireland) has been proposed as infillbiomaterial to treat fistulas [but data on its use on P. Sileri (*) : L. Franceschilli : G. Del Vecchio Blanco : anal fistula treatment is scant. We propose a novel approach V. M. Stolfi : G. P. Angelucci : A. L. GaspariDepartment of Surgery (Dir. Achille L. Gaspari), consisting in non-cutting seton positioning followed by flap University of Rome Tor Vergata, Policlinico Tor Vergata, repair associated with Permacol injection into the fistula tracts after. We also report our experience with this two- staged procedure on 11 consecutive patients with recurrent 00133 Rome, Italye-mail: [email protected] Between July 2009 and April 2010, 11 consecutive patientsunderwent mucosal advancement flap repair and Permacolinjection for complex anal fistula in our institution.
Inclusion criteria for this study were age between 18 and75 years and the presence of a complex anal fistula, definedas Crohn's, rectovaginal, and high trans-sphincteric fistulas.
Patients' characteristics are resumed in Table All patients underwent outpatient clinic evaluation and preoperative MRI and/or endoscopic ultrasound. Fecalincontinence before and after surgery was evaluated usingthe Fecal Incontinence Severe Index (FISI) score. Patientswith a score >6 underwent anal manometry before surgery.
All procedures consisted in two-stage approach.
Surgical technique, stage I On the day of the surgery, anenema was administered to the patient. All patientsunderwent surgery under general anesthesia in lithotomyposition and broad-spectrum antibiotics given at induction.
The internal orifice was found using oxygen peroxideinjection through the external opening and gently probed.
At this point a non-cutting seton (Silicone Surgical Vessel Fig. 1 Flap preparation (mucosa, submucosa, and a small amount of Loop, Dev-o-Loop, Mini-red, Covidien) was placed for a internal sphincter fibers) after >6 weeks drainage seton insertion period of at least 8 weeks aiming adequate drainage of the which aimed draining the fistula tract thus abolishing collateral tractswhile transforming it in a more straight one sepsis and followed up routinely as outpatient.
Surgical technique, stage II Surgery was performed in a The flap base was performed large enough to avoid its day surgery setting, under general anesthesia in the ischemia and mobilization to avoid tension. The fistula tract lithotomy position. Initial step was the identification and was probed, curetted, and irrigated with saline. The internal creation of an elliptical excision below the internal opening opening underneath the mobilized flap was not closed encompassing 20–30% of the circumference of the anus.
before suturing. The flap was sutured distally using full- The rectal flap, fashioned with mucosa, submucosa, and a thickness-interrupted vicryl 2-0 sutures (Fig. At this small amount of internal sphincter fibers, was adequately point, liquid dermal porcine matrix (Permacol Injection, mobilized to overlap and cover the internal opening.
Covidien plc, Dublin, Ireland) was gently injected in the Particular care on hemostasis was given to prevent retrograde manner through the external orifice to fill the entire tract. The entire procedure was performed under Fig. 2 a and b The flap (mucosa,submucosa and a small amount ofmuscular fibers) was sutured usinginterrupted 00 absorbable sutures.
Subsequently the fistula tract wasfilled with the preparation underdirect visual control. The externalorifice was then closed with a 00silk suture to prevent earlyextrusion. The infill preparationwas also injected all around thefistula tract nearby the externalorifice direct vision of the flap in order to prevent anterograde fluconazole (per os 200 mg/day). Mean follow-up after extrusion and flap tension (Fig. In order to prevent surgery was 9 months and we observed a single failure after early extrusion of the matrix injection, at this point, 6 weeks secondary to partial displacement. This failure was additional injection was performed next to the fistula tract observed in a Crohn's disease patient who experienced a at 360° through a 20-gauge needle and the external orifice severe recurrence of intraluminal disease with frequent was closed using a purse-string or figure of eight suture bowel motions (>10/day). No difference in terms of with silk 00. This suture was then removed at the first preoperative and postoperative FISI scores was observed in all but one patient who experienced transitory gas incontinence After the discharge, patients were followed-up 1, 2, 4 weeks after surgery and then routinely every 4 months.
Data was collected prospectively including demographics,previous treatments, details of surgery, and follow-up results.
Nowadays, flap repair remains the “gold standard” approachfor the treatment of high trans-sphincteric perianal or complex fistulas. The flap repair, closing the internal anorectal opening,eliminates the source of persisting anal fistula where fecal Overall, 11 patients who had complex anal fistula of material is forced through. Healing rates are reported to range cryptoglandular origin (five patients) and inflammatory between 37% and 98% , , Lower recurrence rates bowel disease (IBD) related (six patients) were treated.
have been observed after non-cutting seton insertion prior Results are summarized in Table . The median age was Over the last two decades the use of biomaterials to treat One patient had previous rectovaginal fistula surgery anal fistula has drawn great interest. Advantages of this which failed and required fecal diversion. All first-stage approach include simple and repeatable applications, procedures were performed as planned day surgery cases.
preservation of sphincter integrity, minimal patient's dis- Eight out of 11 second-stage procedures were carried in a day comfort, and the ability for subsequent surgical options if surgery setting, while three required overnight admission needed. Among these, fibrin glue injection has been because of age (one patient) and postoperative pain (two proposed to obliterate the fistula tract/s, but initial enthu- patients). No postoperative complications were observed as siasms have been tempered by disappointing high rates of part of a fungi infection substained by Candida albicans, recurrences [–, Failures are attributable to the which was successfully treated with a 7-days cycle of displacement of the glue from the fistula tracts early after surgery secondary to increased pressure from coughing or that this combined approach offers several potential straining [Other reasons suggested for the persistence advantages compared to fibrin glue injection alone or of fistula tracts have included chronic infection, residual after flap repair. The earlier non-cutting seton insertion granulation tissue or islands of epithelium being left behind allows a good drainage of the sepsis, fistula cavities, and, in the tract. As a matter of fact most of the authors point out when present, the obliteration of all (either known or the need of the tract curettage before sealant injection ].
unrecognized) secondary fistula tracts. At the second-stage Several authors have tried a combination of fibrin glue surgery, the injection would cover a single, possibly and flap repair in order to enhance its success rates [, . Results have been disappointing, showing worse The flap repair (mucosal, submucosal, and some muscle outcomes after the combination of the two compared to fibers), covering the internal source of the fistula, would flap repair alone ]. Reasons why fibrin glue addition is prevent extrusion of the Permacol injection as already ineffective or even worse are unclear. A possible explana- shown by several studies using fibrin glue. In our opinion, tion can be that the closure of the fistula tract with the glue the reported failures using the combination of the two leads to a situation where insufficient drainage from the techniques can be explained with the need of correct fistula primary and eventual secondary fistula tract occurs [].
anatomy identification and previous drainage of the sepsis Furthermore, other authors have mentioned incomplete obtained with the use of loose seton drainage as bridge to filling of the fistula tract because of cavitary fistula tracts flap repair surgery. The injected matrix offers a scaffold for or the presence of side branches. Lindsey et al. reported the scar formation and tissue regeneration. However some efficacy of endorectal ultrasound to identify fistula anato- limits are still evident. At the present time, this injectable my, thus, the use of this approach preoperatively to improve preparation is too liquid and this may lead to an immediate results [A two-staged technique, using non-cutting extrusion after injection. Despite that it has been success- seton followed by a period of healing before glue injection fully used for this purpose in outpatient setting as single injection through the external orifice and around it [our Recently, a porcine dermal matrix injection (Permacol experience with its use in outpatient setting for anal fistula Injection-Covidien plc, Dublin, Ireland) has been used as (after previous seton placement) or sinus resulted unfavor- infill biomaterial to treat fistulas []. Permacol is a able and all patients (5 patients, data not published) commercially available porcine dermal collagen developed eventually required surgery. The sudden extrusion of the as sheet or liquid injection. It is non-allergenic, non- infill material might be responsible for this result. The early antigenic, and entirely biocompatible. It has been used extrusion is also observed after flap advancement surgery, successfully in many different ways, including abdominal thus in order to prevent extrusion we perform a purse-string wall hernia repairs including incisional and parastomal suture around the external orifice to avoid leaks during the hernia as well as for pelvic floor surgery [. The first three postoperative days and thereafter we remove the injectable form is a 50% per by volume collagen particles suture to prevent potential suppurations.
in saline and presently the most evident limit to fill in a In conclusion, Permacol injection with advancement flap fistula track is its extremely liquid consistency. It has been repair seems to be safe and effective. A previous seton used in cases of anal and urinary incontinence and for insertion is mandatory to “clean” the fistula cavities and tracts plastic surgery. At the present time, literature data experi- and to “ameliorate” fistula anatomy. The current preparation ence on its use to treat anal fistulas is scant. Himpson et al., does not allow the use as infill material in outpatient care even in a experimental porcine model of fistula-in-ano, concluded if fistula tract has been previously drained with seton.
that when the fistula track is completely removed and Obviously a longer follow-up and large series are needed to durable infill material used, it is possible to treat fistulas successfully even in presence of infection or contamina-tion []. The same authors suggested that it is likely that Acknowledgment Mrs. Brega Fiorella for the preparation of the because of the cross-linked nature of Permacol, it provides tissue repair regeneration with stability and facilitatescontrolled and ordered wound healing. However in theirexperience, the “too liquid” injectable preparation was modified by centrifugation to produce a thicker paste toprevent extrusion from the tract. Initial clinical use is even 1. Davies M, Harris D, Lohana P, Chandra Sekaran TV, Morgan less documented. In this study, we report our experience AR, Beynon J, Carr ND (2008) The surgical management of with a novel approach consisting in non-cutting seton fistula-in-ano in a specialist colorectal unit. Int J Colorectal Dis23(9):833–838 positioning followed by flap repair associated with 2. Garcia-Aguilar J, Belmonte C, Wong WD, Goldberg SM, Permacol injection into the fistula tracts after. We believe Madoff RD (1996) Anal fistula surgery. Factors associated with recurrence and incontinence. Dis Colon Rectum 39 11. Sentovich SM (2003) Fibrin glue for anal fistulas: long-term results. Dis Colon Rectum 46(4):498–502 3. Quah HM, Tang CL, Eu KW, Chan SY, Samuel M (2006) Meta- 12. Zmora O, Mizrahi N, Rotholtz N, Pikarsky AJ, Weiss EG, analysis of randomized clinical trials comparing drainage alone vs Nogueras JJ, Wexner SD (2003) Fibrin glue sealing in the primary sphincter-cutting procedures for anorectal abscess-fistula. Int treatment of perineal fistulas. Dis Colon Rectum 46(5):584–589 J Colorectal Dis 21(6):602–609, Epub 2005 Nov 30. Review 13. Himpson RC, Cohen CR, Sibbons P, Phillips RK (2009) An 4. Taxonera C, Schwartz DA, García-Olmo D (2009) Emerging experimentally successful new sphincter-conserving treatment for treatments for complex perianal fistula in Crohn's disease. World J anal fistula. Dis Colon Rectum 52(4):602–608 14. Milito G, Cadeddu F (2009) Conservative treatment for anal 5. Ellis CN, Clark S (2006) Fibrin glue as an adjunct to flap repair of fistula: collagen matrix injection. J Am Coll Surg 209(4):542–543, anal fistulas: a randomized, controlled study. Dis Colon Rectum 15. Ortiz H, Marzo M, de Miguel M, Ciga MA, Oteiza F, Armendariz 6. Singer M, Cintron J, Nelson R, Orsay C, Bastawrous A, Pearl R, P (2008) Length of follow-up after fistulotomy and fistulectomy Sone J, Abcarian H (2005) Treatment of fistulas-in-ano with fibrin associated with endorectal advancement flap repair for fistula in sealant in combination with intra-adhesive antibiotics and/or surgical closure of the internal fistula opening. Dis Colon Rectum 16. Chung W, Kazemi P, Ko D, Sun C, Brown CJ, Raval M, Phang T (2009) Anal fistula plug and fibrin glue versus conventional 7. van Koperen PJ, Wind J, Bemelman WA, Slors JF (2008) Fibrin treatment in repair of complex anal fistulas. Am J Surg 197 glue and transanal rectal advancement flap for high transsphincteric perianal fistulas; is there any advantage? Int J Colorectal Dis 23 17. Williams JG, MacLeod CA, Rothenberger DA, Goldberg SM (1991) Seton treatment of high anal fistulae. Br J Surg 78 8. Ellis CN (2007) Bioprosthetic plugs for complex anal fistulas: an early experience. J Surg Educ 64(1):36–40 18. Hammond TM, Grahn MF, Lunniss PJ (2004) Fibrin glue in the 9. Miller GV, Finan PJ (1998) Flap advancement and core management of anal fistulae. Colorectal Dis 6(5):308–19, Review fistulectomy for complex rectal fistula. Br J Surg 85(1):108– 19. Chung W, Ko D, Sun C, Raval MJ, Brown CJ, Phang PT (2010) Outcomes of anal fistula surgery in patients with inflammatory 10. Buchanan GN, Bartram CI, Phillips RK, Gould SW, Halligan S, bowel disease. Am J Surg 199(5):609–613 Rockall TA, Sibbons P, Cohen RG (2003) Efficacy of fibrin 20. Lindsey I, Humphreys MM, George BD, Mortensen NJ (2002) sealant in the management of complex anal fistula: a prospective The role of anal ultrasound in the management of anal fistulas.
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