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• W2565100013 abstract "Colorectal DiseaseVolume 10, Issue 1 p. 17-20 Free Access The surgisis® AFP™ anal fistula plug: report of a consensus conference* First published: 19 November 2007 https://doi.org/10.1111/j.1463-1318.2007.01423.xCitations: 14 Marvin L. Corman, Department of Surgery, HSC 18-060, Stony Brook, NY 11794-8191, USA.E-mail: marvin.corman@stonybrook.edu * Committee members: Herand Abcarian – Department of Surgery, University of Illinois College of Medicine at Chicago; H. Randolph Bailey – University of Texas Medical School at Houston, University of Texas M.D. Anderson Cancer Center Division of Surgery and Baylor College of Medicine, Houston, Texas; Elisa H. Birnbaum – Washington University School of Medicine, St. Louis, Missouri; Bradley J. Champagne – Case Western Reserve University, Cleveland, Ohio; Jose R. Cintron – Division of Colon and Rectal Surgery, University of Illinois College of Medicine at Chicago; Marvin L. Corman – Chairman, Division of Colon and Rectal Surgery, Stony Brook University, Stony Brook, NY; C. Neal Ellis – University of South Alabama College of Medicine, Mobile, Alabama; Charles O. Finne III – University of Minnesota, Minneapolis, Minnesota; Andreas M. Kaiser – Keck School of Medicine of the University of Southern California, Los Angeles; Alex J. Ky – Department of Surgery, The Mount Sinai School of Medicine, New York, NY; Jorge E. Marcet – University of South Florida, Tampa, FL; Madeleine Poirier – Department of Pathology, McGill University Health Center, Montreal, Quebec, Canada; Michael J. Snyder – The University of Texas Medical School at Houston; Scott A. Strong – Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio; Eric G. Weiss – Department of Colorectal Surgery, Cleveland Clinic Florida; The Cleveland Clinic Foundation Health Sciences Center of Ohio State University; Department of Surgery, University of South Florida, Tampa, FL. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat A Consensus Conference was held in Chicago on 27th May 2007 at the Illinois Airport Hilton Hotel to develop uniformity of opinion from surgeons with considerable experience in the use of the Anal Fistula Plug. Of the 15 surgeons in attendance, five had performed 50 or more Anal Fistula Plug procedures. Success rates with this approach have been reported to be as high as 85% [1]. Anecdotal communications have however suggested lower rates of success. Concerns have been expressed over plug extrusion and inadequacy of long-term follow-up. It was thought prudent to hold this conference because, despite a number of publications attesting to the safety and efficacy of the procedure, to date there has not been uniformity of opinion regarding indications and technique, nor has there been level I evidence of any actual benefit. Plug material, mechanism and applications Small intestinal submucosa (SIS) is a natural biomaterial harvested from porcine small intestine and fabricated into a biomedical product of various shapes and thicknesses [2]. As such it has been applied to a host of potential indications. These include reinforcement of soft tissue for incisional and inguinal herniorraphy; urethral sling placement in urogynaecology; staple line reinforcement; paraesophageal hernia repair and in the treatment of anal fistula [3-13]. The fact that it has been demonstrably useful as a bioprosthetic material in infected fields makes its application in fistula surgery quite reasonable. The SurgisisR AFPTM Anal Fistula Plug (the plug) has a biological configuration suitable for fistula disease. When SIS is implanted, host tissue cells and blood vessels colonize the ‘graft’. In essence, SIS provides a scaffold or matrix to allow infiltration of the patient’s connective tissue. The material is supplied in a sterile, peel-open package and is intended for one-time use. Recommendations All of the following recommendations and opinions of the consensus panel were unanimously agreed by those present unless otherwise indicated. Inclusion/exclusion criteria Indications for the use of the plug include: Transsphincteric fistula This was considered to be the ideal indication for the use of the plug. Anovaginal fistula While it was recognized that the shorter the tract the less likely the procedure would be successful, the plug was felt to be a reasonable alternative to other operations. Besides the financial cost of failure there appeared to be no disadvantage in attempting its use in this circumstance. Intersphincteric fistula The Consensus Panel felt that the use of the plug for this indication was valid, if conventional fistulotomy posed a significant risk of incontinence. This would include those patients with inflammatory bowel disease and those who had previously undergone radiation therapy. Extrasphincteric fistula While this was recognized to be an uncommon indication for fistula surgery, it was regarded as an indication for the fistula plug. Suturing the plug to the site of the internal opening was considered to be potentially technically difficult. Contraindications for the use of the plug include: Conventional, uncomplicated intersphincteric fistula Success approaches 100% with minimal morbidity with standard fistulotomy. Thus, the cost/failure rate with the use of the plug cannot be justified. In addition, the following conditions were felt to be inappropriate because of the extremely low probability of success: 1 Pouch-vaginal fistula. 2 Recto-vaginal fistula (because of the short length of the track). 3 Fistula with a persistent abscess cavity. 4 Fistula with any suggestion of infection. Examples included those with associated anorectal abscess formation, persistent cavity (as above), and a fistula with induration or purulent drainage. 5 Allergy to porcine products. 6 Inability of the surgeon to identify both the external and internal openings. This is an absolute contraindication for undertaking this procedure. Preoperative preparation Some surgeons experienced in using the plug have prepared the bowel as for a major colon resection, with laxatives and antibiotics. The Consensus Panel questioned the value of attempts to delay defecation. They queried whether liquid stool was preferable to solid for prevention of extrusion of the plug. When the use of a small-volume preoperative enema was considered, there was no consensus: half of the Panel felt it would be useful. It was accepted that there was no evidence base for this consideration. Therefore, in the absence of data, the Panel concluded that bowel preparation and/or the use of a small volume enema should be left to the individual surgeon’s personal preference. The Panel did recommend a single preoperative dose of systemic antibiotics but felt that this should not be continued for longer. Intraoperative management Anaesthetic This was deemed to be a matter of the patient’s or surgeon’s preference. Positioning the patient This was regarded as a matter of the surgeon’s preference. The critical element, however, was to ensure adequate visualization of the internal opening to place the suture correctly. Surgical technique Identifying the internal and external openings The plug cannot be inserted unless there is clear delineation of the primary and secondary openings. Irrigation of the track with saline or peroxide was recommended. Passing a probe Gentle passage of a probe was essential to confirm the position of the track and to facilitate insertion of the plug. The Panel unanimously affirmed that debridement, curettage or brushing of the tract should not be performed. Such manoeuvres would enlarge the fistula track. Using a seton There was uniformity of opinion that a seton should always be employed temporarily until there was no evidence of acute inflammation, purulence or excessive drainage. This would often take 6–12 weeks. However, the use of a seton prior to implantation was unnecessary if there was no acute inflammatory process. Preparing the plug The AFP plug should be completely immersed in sterile saline for 2 min. Allowing immersion for >5 min risks fragmentation of the plug. Conversely, implantation of a nonhydrated plug is extremely painful. Managing the recessed internal opening If there is epithelialization of the internal opening (dimpled or recessed), limited mobilization of the mucosal edges with debridement prior to suture placement should be considered. Passing the plug The use a suture or ligature was recommended to pull the narrow end of the plug from the internal opening through the track to the external opening until the plug is snug. Trimming the plug Any excess plug should be trimmed at the level of the internal opening (the wide end) and sutured with 2–0 long-term, braided, absorbable material (e.g. Vicryl, Ethicon, Inc., Somerville, NJ, USA), incorporating the underlying internal anal sphincter. Monofilament material should not be used. There was no consensus, however, as to whether the plug should be buried under the mucosa. The excess external plug should be trimmed flush with the skin without fixation. The external opening may be enlarged if necessary to facilitate drainage. Postoperative care The Panel had a stimulating discussion on various postoperative management alternatives. However, in the absence of evidence-based data, opinions revolved around what seemed reasonable and appropriate with more emphasis on the ‘art’ rather than the ‘science’ of surgery. There were nevertheless several unanimous conclusions. 1 Diet. No dietary restrictions. 2 Activity. No strenuous activity, exercise or heavy lifting for 2 weeks. Abstinence from sexual intercourse for 2 weeks. 3 External dressing. For patient comfort only. 4 Topical antibiotics. Not indicated. 5 Cleansing. Showers with gentle cleaning. 6 Bowel management. Medications as necessary to prevent constipation or diarrhoea. 7 Follow-up visits. Surgeon’s preference. The tract should not be probed during these visits. Outcome Defining failure Early extrusion of the plug is either a technical error [the track being too large, the plug pulled too tightly, faulty fixation (i.e. to the mucosa rather than to the internal sphincter)] or infection. The Panel unanimously agreed that the overwhelming majority of fistulas which heal do so within 3 months, although some will take longer. The decision whether the operation should be considered a failure rests with the individual surgeon, but should not be taken for a minimum of 3 months. Conclusions The anal fistula plug was felt to be a reasonable alternative for the treatment of anal fistula. Members of the Panel were asked to state what they felt to be a reasonable rate of success and concluded that 50–60% should be considered acceptable. To achieve the highest possibility of success, the Panel concluded that patient selection, avoidance of local infection, and meticulous technique were required. Besides the consideration of cost it was felt that the patient would not be adversely affected by insertion of the fistula plug because all other management options were still available. It was recognized, however, that even in patients with apparent healing the rate of subsequent recurrence was unknown. Prospective randomized trials comparing the anal fistula plug with other treatments such as seton fistulotomy were recommended. Finally it was unanimously agreed that the procedure should be undertaken only by trained surgeons familiar with anorectal anatomy and experienced in conventional anal fistula surgery and in the management of its complications. Conflict of interest statement All of the participants in the Conference received reimbursement for their expenses through Cook Medical Incorporated (Bloomington, IN, USA), and everyone received an honorarium for dedicating his or her weekend to the task. References 1 Champagne BJ, O’Connor LM, Ferguson M et al. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up. Dis Colon Rectum 2006; 49: 1817– 21. CrossrefPubMedWeb of Science®Google Scholar 2 Badylak SF. (1993) Small intestinal submucosa (SIS): a biomaterial conducive to smart tissue remodeling. In: Tissue Engineering: Current Perspectives (ed. E Bell), pp. 179– 89. Burkhauser, Cambridge. CrossrefWeb of Science®Google Scholar 3 Edelman DS. Laparoscopic herniorraphy with porcine small intestinal submucosa: a preliminary study. JSLS 2002; 6: 203– 5. PubMedGoogle Scholar 4 Ellis CN. Bioprosthetic plugs for complex anal fistulas: an early experience. J Surg Educ 2007; 64: 36– 40. CrossrefPubMedGoogle Scholar 5 Franklin ME, Gonzalez JJ, Glass JL. Use of porcine small intestinal mucosa as a prosthetic device for laparoscopic repair of hernias in contaminated fields: 2-year follow-up. Hernia 2004; 8: 3– 6. CrossrefGoogle Scholar 6 Franklin ME, Gonzalez JJ, Michaelson RP et al. Preliminary experience with new bioactive prosthetic material for repair of hernias in infected fields. Hernia 2002; 6: 171– 4. CrossrefPubMedWeb of Science®Google Scholar 7 Helton WS, Fisichella PM, Berger R et al. Short-term outcomes with small intestinal submuca in the management of infected or potentially contaminated abdominal defects. J Gastrointest Surg 2004; 8: 109– 12. CrossrefPubMedWeb of Science®Google Scholar 8 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. CrossrefPubMedWeb of Science®Google Scholar 9 O’Connor L, Champagne BJ, Ferguson MA et al. Efficacy of anal fistula plug in closure of Crohn’s anorectal fistulas. Dis Colon Rectum 2006; 49: 1569– 73. CrossrefPubMedWeb of Science®Google Scholar 10 Oelschlager BK, Barreca M, Chang L, Pellegrini CA. The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique. Am J Surg 2003; 186: 4– 8. CrossrefPubMedWeb of Science®Google Scholar 11 Robb BW, Vogler SA, Nussbaum N, Sklow B (2004) Early Experience Using Porcine Small Intestinal Submucosa to Repair Fistulas-in-Ano. Poster Session, 8–13 May 2004, Annual Meeting, American Society of Colon and Rectal Surgeons, Dallas. Google Scholar 12 Schultz DJ, Brasel KJ, Spinelli KS et al. Porcine small intestine submucosa as a treatment for enterocutaneous fistulas. JACS 2002; 194: 541– 3. CrossrefPubMedWeb of Science®Google Scholar 13 Ueno T, Pickett LC, De La Feunte SG et al. Clinical application of porcine small intestinal submucosa in the management of infected or potentially contaminated abdominal wall defects. J Gastrointest Surg 2004; 8: 109– 12. CrossrefPubMedWeb of Science®Google Scholar Citing Literature Volume10, Issue1January 2008Pages 17-20 ReferencesRelatedInformation" @default.
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