Anal Fistula Plug Research Articles

Treatment of Crohn's Fistulae Using an Anal Fistula Plug of Porcine Small Intestinal Submucosa Origin

Objective: This study was designed to evaluate the efficacy of the Biodesign ® Anal Fistula Plug (AFP) for the closure of Crohn's anorectal fistula. Patients & Methods: This study was a prospective analysis of patients with Crohn's disease who received the AFP for the treatment of anorectal fistulas of Crohn's origin. Under general anesthesia and in the lithotomy or prone jackknife posi- tion, patients underwent irrigation of the fistula tract by saline or hydrogen peroxide. The AFP was then inserted into the fistula tract until it was snug. The internal end of the plug was securely sutured with 2-0 Vicryl ® and covered with a small mucosal advancement flap, while the external opening was left open to allow for drainage. Results: Twenty-one patients with a combined 28 fistula tracts were prospectively enrolled. Three single tract fistula pa- tients were lost to follow up and were excluded from the analysis. At the final follow-up of 12 months, all fistula tracts were successfully closed in 10 of 18 patients, for an overall success rate of 56%; total fistula tracts were closed in 17 of 25 tracts, for an overall success rate of 68%. None of the tracts that were closed recurred during the study period. Conclusions: Closure of Crohn's anorectal fistulas using the anal fistula plug is safe and successful in 56% of patients and 68% of fistula tracts. Given the relatively low morbidity associated with the procedure, the AFP should be considered as a viable treatment option for patients with Crohn's-associated anorectal fistulas.

Ligation of Intersphincteric Fistula Tract

Transsphincteric fistulotomy is associated with a variable degree of fecal incontinence that is directly related to the thickness of the sphincter mechanism overlying the fistula. Staged fistulotomy with seton or the use of cutting seton designed to reduce the proportionate incontinence rates have failed to do so. This has resulted in attempts to find novel sphincter-sparing techniques in the past 2 decades including draining seton, fibrin sealant, anal fistula plug, dermal advancement, and endorectal advancement flaps. These operations have a variable success rates of 30% to 80% reported in the literature. In 2007, Rojanasakul from Thailand demonstrated a novel technique, ligation of intersphincteric fistula tract, and reported a 94% success rate in a small series. Since then, a few other small cohorts of patients have been reported in the literature with success rates varying from 57% to 82%. An institutional review board-approved study was proposed to measure our results and compare them with the published data. This study was undertaken to evaluate the success of ligation of intersphincteric fistula tract procedures in a group of unselected transsphincteric fistulas deemed unsuitable for lay-open fistulotomy. The procedure was performed in 3 different settings: a public institution, a major university hospital, and a large private hospital. A total of 40 patients underwent 41 ligation of intersphincteric fistula tract procedures performed by 6 Board-certified colon and rectal surgeons. In a mean follow-up of 18 weeks, 74% of the patients achieved healing. In patients who underwent ligation of intersphincteric fistula tract as their primary procedure, the healing rate was 90%. The limitation of this study is its "case series" nature and the short mean follow-up period of 18 weeks. Ligation of intersphincteric fistula tract has had excellent success in transsphincteric fistulas in multiple small series. A larger number of patients and longer follow-up period are needed to validate the early favorable results.

Is the Placement of the New Synthetic Anal Fistula Plug Really So Ineffective?

Is the Placement of the New Synthetic Anal Fistula Plug Really So Ineffective?

Initial experience of treating anal fistula with the Surgisis anal fistula plug

Complex anal fistulas remain a challenge for the colorectal surgeon. The anal fistula plug has been developed as a simple treatment for fistula-in-ano. We present and evaluate our experience with the Surgisis anal fistula plug from two centres. Data were prospectively collected and analysed from consecutive patients undergoing insertion of a fistula plug between January 2007 and October 2009. Fistula plugs were inserted according to a standard protocol. Data collected included patient demographics, fistula characteristics and postoperative outcome. Forty-four patients underwent insertion of 62 plugs (27 males, mean age 45.6years), 25 of whom had prior fistula surgery. Mean follow-up was 10.5months Twenty-two patients (50%) had successful healing following the insertion of plug with an overall success rate of 23 out of 62 plugs inserted (35%). Nineteen out of 29 patients healed following first-time plug placement, whereas repeated plug placement was successful in 3 out of 15 patients (20%; p=0.0097). There was a statistically significant difference in the healing rate between patients who had one or less operations prior to plug insertion (i.e. simple fistulas) compared with patients who needed multiple operations (18 out of 24 patients vs. 4 out of 20 patients; p=0.0007). Success of treatment with the Surgisis anal fistula plug relies on the eradication of sepsis prior to plug placement. Plugs inserted into simple tracts have a higher success rate, and recurrent insertion of plugs following previous plug failure is less likely to be successful. We suggest the fistula plug should remain a first-line treatment for primary surgery and simple tracts.

A Systematic Review of the Anal Fistula Plug for Patients With Crohn's and Non-Crohn's Related Fistula-in-Ano

The management of fistula-in-ano is a balance between fistula cure and preservation of continence. The aim of this study is to summarize the anal fistula plug literature for Crohn's and non-Crohn's fistula-in-ano in a homogenous patient population. PubMed, MEDLINE, Embase, and Cochrane medical databases were searched from 1995 to 2011. Abstracts from The American Society of Colon and Rectal Surgeons, The Society for Surgery of the Alimentary Tract, The European Society of Coloproctology, and the Association of Coloproctology of Great Britain and Ireland meetings between 2007 and 2010 were also evaluated. Studies were included if results for patients with and without Crohn's disease could be differentiated. Patients with rectovaginal, anovaginal, rectourethral, or ileal-pouch vaginal fistulas were excluded as were studies where the mean or median follow-up was less than 3 months. Two researchers independently selected studies matching the inclusion criteria. Anal fistula plug insertion was performed. The primary outcomes measured were the overall fistula closure rates and length of follow-up. Seventy-six articles or abstracts were identified from the title as being of relevance. Twenty studies (2 abstracts, 18 articles) were finally included. Study sample size ranged from 4 to 60 patients; 530 patients were included in all studies (488 non-Crohn's and 42 Crohn's patients). The plug extrusion rate was 8.7% (46 patients). The proportion of patients achieving fistula closure varied widely between studies for non-Crohn's, ranging from 0.2 (95% CI 0.04-0.48) to 0.86 (95% CI 0.64-0.97). The pooled proportion of patients achieving fistula closure in patients with non-Crohn's fistula-in-ano was 0.54 (95% CI 0.50-0.59). The proportion achieving closure in patients with Crohn's disease was similar (0.55, 95% CI 0.39-0.70). This study was limited by the variability of operative technique and perioperative care between studies. Fistula closure is achieved by using the anal fistula plug in approximately 54% of patients without Crohn's disease. The anal fistula plug has not been adequately evaluated in the Crohn's population.

Evolution of Treatment of Fistula in Ano

Fistula-in-ano is a common medical problem affecting thousands of patients annually. In the past, the options for treatment of fistula-in-ano were limited to fistulotomy and/or seton placement. Current treatment options also include muscle-sparing techniques such as a dermal island flap, endorectal advancement flap, fibrin sealent injection, anal fistula plug, and most recently ligation of the intersphincteric fistula tract (procedure). This study seeks to evaluate types and time trends for treatment of fistula-in-ano. A retrospective review from 1975 to 2009 was performed. Data were collected and sorted into 5-year increments for type and time trends of treatment. Fistulotomy and partial fistulotomy were grouped as cutting procedures. Seton placement, fibrin sealant, dermal flap, endorectal flap, and fistula plug were grouped as noncutting procedures. Statistical analysis was performed for each time period to determine trends. With institutional review board approval, the records of 2,267 fistula operations available for analysis were included. Most of the patients were men (74 vs. 26%). Cutting procedures comprised 66.6% (n = 1510) of all procedures. Noncutting procedures were utilized in 33.4% (n = 757), including Seton placement alone 370 (16.3%), fibrin sealant 168 (7.4%), dermal or endorectal flap 147 (6.5%), and fistula plug 72 (3.2%). The distribution of operations grouped in 5-year intervals is as follows: 1975-1979, 78 cutting and one noncutting; 1980-1984, 170 cutting and 10 noncutting; 1985-1989, 54 cutting and five noncutting; 1990-1994, 37 cutting and six noncutting; 1995-1999, 367 cutting and 167 noncutting; 2000-2004, 514 cutting and 283 noncutting; 2005-2009, 290 cutting and 285 noncutting. The percentage of cutting and noncutting procedures significantly differed over time, with cutting procedures decreasing and noncutting procedures increasing proportionally (χ(2) linear-by-linear association, p < 0.05). Fistula-in-ano remains a common complex disease process. Its treatment has evolved to include a variety of noncutting techniques in addition to traditional fistulotomy. With the advent of more sphincter-sparing techniques, the number of patients undergoing fistulotomy should continue to decrease over time. Surgeons should become familiar with various surgical techniques so the treatment can be tailored to the patient.

Anal fistula plug vs mucosa advancement flap in complex fistula-in-ano: A meta-analysis

To investigate the efficacy of the anal fistula plug (AFP) compared to the mucosa advancement flap (MAF), considered the best procedure for patients with a complex anal fistula. The literature search included PubMed, EMBASE, Cochrane Library and OVID original studies on the topic of AFP compared to MAF for complex fistula-in-ano that had a deadline for publication by April 2011. Randomized controlled trials, controlled clinical trials and prospective cohort studies were included in the review. After information collection, a meta-analysis was performed using data on overall success rates as well as incidence of incontinence and morbidity. The quality of postoperative life was also included with the clinical results. Six studies involving 408 patients (AFP = 167, MAF = 241) were included in the meta-analysis. The differences in the overall success rates and incidence of fistula recurrence were not statistically significant between the AFP and MAF [risk difference (RD) = -0.12, 95%CI: -0.39 - 0.14; RD = 0.13; 95%CI: -0.18 - 0.43, respectively]. However, for the AFP, the risk of postoperative impaired continence was lower (RD = -0.08, 95%CI: -0.15 - -0.02) as was the incidence of other complications (RD = -0.06, 95%CI: -0.11 - -0.00). The postoperative quality of life, for patients treated using the AFP was superior to that of the MAF patients. Patients treated with the AFP had less persistent pain of a shorter duration and the healing time of the fistula and hospital stay were also reduced. The AFP is an effective procedure for patients with a complex anal fistula; it has the same success rate but a lower risk of complications than the MAF and may also be associated with an improved postoperative quality of life. Additional evidence is needed to confirm these findings.

New techniques for treating an anal fistula.

Surgery for an anal fistula may result in recurrence or impairment of continence. The ideal treatment for an anal fistula should be associated with low recurrence rates, minimal incontinence and good quality of life. Because of the risk of a change in continence with conventional techniques, sphincter-preserving techniques for the management complex anal fistulae have been evaluated. First, the anal fistula plug is made of lyophilized porcine intestinal submucosa. The anal fistula plug is expected to provide a collagen scaffold to promote tissue in growth and fistula healing. Another addition to the sphincter-preserving options is the ligation of intersphincteric fistula tract procedure. This technique is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Recently, cell therapy for an anal fistula has been described. Adipose-derived stem cells have two biologic properties, namely, ability to suppress inflammation and differentiation potential. These properties are useful for the regeneration or the repair of damaged tissues. This article discusses the rationales for, the estimated efficacies of, and the limitations of new sphincter-preserving techniques for the treatment of anal fistulae.

Analysis of mechanical response of fistula plug for structure optimization

Anal fistula is one of the three greatest anorectal diseases with a high prevalence. The traditional treatments(e.g., surgery) for fistula have limitations due to damage to the internal anal sphincter of patients. With recent advances in biomaterials, treatments based on biomaterial filling (e.g., scleraprotein injection, fistula plug) have emerged as novel therapies for fistula. The anal fistula plug (e.g., based on small intestinal submucosa (SIS)) has attracted increasing attention because of short term healing rate and biocompatibility. However, challenges remain for this method such as plug falling as observed in clinics. To address this, this paper analyzes the case of SIS falling under physiological condition from mechanical point of view using ANSYS simulation. It then proposes three new geometrical structures for fistula plug and compares their mechanical behavior (e.g., axial stress, reaction of constraint) with that of clinically used structure (cone shape). Based on the simulation, it optimizes the geometric parameters of fistula plug. The approach developed here can help to improve the design of fistula plug for better clinical treatments.

Long-term Efficacy of the Button Fistula Plug in the Treatment of Ileal Pouch-vaginal and Crohn's-related Rectovaginal Fistulas

Several new techniques have been described for the management of anal fistulas. The anal fistula plug has received much attention. The button plug adaptation has been heralded for use in rectovaginal and ileal pouch-vaginal fistulas. The aim of this study was to report the long-term efficacy of the button plug in patients with such fistulas. All women with ileal pouch-vaginal and rectovaginal fistulas secondary to Crohn's disease who underwent insertion of a novel button fistula plug between May 2008 and November 2009 were prospectively evaluated. At long-term follow up of a median of 118 (interquartile range, 81.5-129.0) weeks, none of the 11 patients (0%) with ileal pouch-vaginal fistulas were considered to have healed, whereas 4 of the 9 patients (44%) with rectovaginal fistulas had healed. Each of these 4 patients whose treatment was successful were nonsmokers with an etiology of Crohn's disease and achieved complete closure of the fistula tract after one procedure, and none had been defunctioned. All repeat procedures failed. The button fistula plug may be an option for patients with Crohn's-related rectovaginal fistulas, albeit with the caveat of advising patients of a less than 50% success rate, but not for patients with ileal pouch-vaginal fistulas. Repeat attempts cannot be justified.

A Systematic Review of the Anal Fistula Plug for Patients With Crohns and Non-Crohns Related Fistula-in-Ano

A Systematic Review of the Anal Fistula Plug for Patients With Crohns and Non-Crohns Related Fistula-in-Ano

The Anal Fistula Plug Treatment Compared With the Mucosal Advancement Flap for Cryptoglandular High Transsphincteric Perianal Fistula: A Double-Blinded Multicenter Randomized Trial

The anal fistula plug was developed as an alternative treatment for perianal fistulas. This study aimed to compare the anal fistula plug with the mucosal advancement flap for the treatment of high transsphincteric fistulas. This study was a double-blinded, multicenter, randomized trial. Sixty patients with perianal fistulas were randomly assigned to receive an anal fistula plug or a mucosal advancement flap and were blinded for the type of treatment. The outcome measures comprised the closure rate, postoperative pain, continence (colorectal functional outcome, Vaizey, and Wexner scores), and quality of life. Closure was determined by clinical examination by a surgeon blinded for the intervention. At a follow-up of 11 months the recurrence rates were 71% (n = 22) in the anal fistula plug group and 52% (n = 15) in the mucosal advancement flap group, which was not significantly different. There were no significant differences in postoperative pain, in pre- and postoperative incontinence scores, soiling, and quality of life. The results of the anal fistula plug and advancement flap procedures are disappointing in the multicenter setting. There were no significant differences in recurrence, functional outcome, and quality of life between the plug and the advancement flap. Because the plug is simple to apply and minimally invasive, it can be considered as an initial treatment option for high transsphincteric fistulas.

Anorectal Infection: Abscess-Fistula

Anorectal abscess and fistula are among the most common diseases encountered in adults. Abscess and fistula should be considered the acute and chronic phase of the same anorectal infection. Abscesses are thought to begin as an infection in the anal glands spreading into adjacent spaces and resulting in fistulas in ~40% of cases. The treatment of an anorectal abscess is early, adequate, dependent drainage. The treatment of a fistula, although surgical in all cases, is more complex due to the possibility of fecal incontinence as a result of sphincterotomy. Primary fistulotomy and cutting setons have the same incidence of fecal incontinence depending on the complexity of the fistula. So even though the aim of a surgical procedure is to cure a fistula, conservative management short of major sphincterotomy is warranted to preserve fecal incontinence. However, trading radical surgery for conservative (nonsphincter cutting) procedures such as a draining seton, fibrin sealant, anal fistula plug, endorectal advancement flap, dermal island flap, anoplasty, and LIFT (ligation of intersphincteric fistula tract) procedure all result in more recurrence/persistence requiring repeated operations in many cases. A surgeon dealing with fistulas on a regular basis must tailor various operations to the needs of the patient depending on the complexity of the fistula encountered.

Management of Cryptoglandular Fistula-in-Ano

The management of complex cryptoglandular fistula has concerned surgeons for millennia. The need to control infection and extirpate the fistula while maintaining the continence mechanism has yielded the development of multiple approaches to fistula management. Seton placement is perhaps the oldest approach to initial control of sepsis and long-term fistula management. Fistulotomy is a time-honored, highly successful approach to fistula, but it can be associated with a varying and significant impact on continence. The advancement flap was developed as a sphincter-sparing method of definitive closure of the internal opening, but this approach is technically difficult and associated with varying degrees of success and impact on continence. The anal fistula plug was introduced as a safe, easy sphincter-sparing approach with excellent early success. Longer-term results and diverse reports, however, have shown disappointing overall success. Newer surgical approaches, such as ligation of the intersphincteric fistula tract, have focused on eradication of the fistula tract and cryptoglandular source in the intersphincteric plane. This method has shown early, promising success but remains to be validated. This technique has also been modified by the use of biological mesh to augment repair and appears promising. The range of approaches and outcomes continues to reinforce the fact that no one approach is the magic bullet. Surgeons need to maintain an armamentarium of approaches to complex fistulae and individualize treatment. Further randomized trials and appropriate, objective assessment of new biological approaches need to be conducted to help guide our treatment choices and improve outcomes.

Why do we have so much trouble treating anal fistula?

Anal fistula is among the most common illnesses affecting man. Medical literature dating back to 400 BC has discussed this problem. Various causative factors have been proposed throughout the centuries, but it appears that the majority of fistulas unrelated to specific causes (e.g. Tuberculosis, Crohn's disease) result from infection (abscess) in anal glands extending from the intersphincteric plane to various anorectal spaces. The tubular structure of an anal fistula easily yields itself to division or unroofing (fistulotomy) or excision (fistulectomy) in most cases. The problem with this single, yet effective, treatment plan is that depending on the thickness of sphincter muscle the fistula transgresses, the patient will have varying degrees of fecal incontinence from minor to total. In an attempt to preserve continence, various procedures have been proposed to deal with the fistulas. These include: (1) simple drainage (Seton); (2) closure of fistula tract using fibrin sealant or anal fistula plug; (3) closure of primary opening using endorectal or dermal flaps, and more recently; and (4) ligation of intersphincteric fistula tract (LIFT). In most complex cases (i.e. Crohn's disease), a proximal fecal diversion offers a measure of symptomatic relief. The fact remains that an "ideal" procedure for anal fistula remains elusive. The failure of each sphincter-preserving procedure (30%-50% recurrence) often results in multiple operations. In essence, the price of preservation of continence at all cost is multiple and often different operations, prolonged disability and disappointment for the patient and the surgeon. Nevertheless, the surgeon treating anal fistulas on an occasional basis should never hesitate in referring the patient to a specialist. Conversely, an expert colorectal surgeon must be familiar with many different operations in order to selectively tailor an operation to the individual patient.

The Anal Fistula Plug as an Adjunct to Transanal Advancement Flap Repair

The Anal Fistula Plug as an Adjunct to Transanal Advancement Flap Repair

A Tale of Two (Anal Fistula) Plugs: Is there a Difference in Short-Term Outcomes?

Treatment of complex anal fistulas presents an ongoing challenge to colorectal surgeons. The anal fistula plug is an attractive definitive option due to its minimal risk of incontinence, simple design, and easy application. Our objective was to compare the Cook Surgisis AFP plug and the newer Gore Bio-A plug in the management of complex anal fistulas. A retrospective chart review of patients treated with Cook and Gore fistula plugs between August 2007 and December 2009 was performed. Success was defined as closure of all external openings and absence of drainage and abscess formation. Twelve Cook patients underwent 16 plug insertions and 10 Gore patients underwent 11 plug insertions. The overall procedural success rate in the Gore group was 54.5 per cent (6 of 11) versus 12.5 per cent (2 of 16) in the Cook group. The reasons for failure were unknown in the majority of patients and plug dislodgement in two patients. Our short-term results with the Gore fistula plug suggest a higher procedural success rate in comparison to the Cook plug. Patients should be cautioned regarding potentially high failure rates; however, longer follow-up and a larger patient population are needed to confirm significant differences in fistula plug efficacy.

Treatment of fistula-in-ano with the Surgisis ® AFP TM anal fistula plug

Closure of the fistula tract with an anal fistula plug has been reported to provide success rates as high as 80%. The purpose of this study was to evaluate our results with this new method. From June 2006 to September 2007, an anal fistula plug was used for the treatment of high transsphincteric fistulas. Success was defined as no residual leakage or abscess formation and closure of the external opening. Fifteen patients (seven women), median age 46 years (range 32-58 years), were included in the study. Three had Crohn's disease, three had an anovulvar fistula and seven had undergone previous surgical-repair attempts. Three patients expelled the prosthesis on postoperative day 2, 5 and 7, respectively, and a second plug placement was followed by expulsion again. One patient developed an abscess that was noted on postoperative day 4. The fistula tract healed in 6/15 patients (40%) after 3 months and in 8/15 (53.3%) after 7 months. The success rate in Crohn's disease was 33%. No significant difference was found between patients with or without previous surgical repair. In our experience, this simple technique provided success rates of 40% at 3 months and 53% at 7 months.

Tract Length Predicts Successful Closure With Anal Fistula Plug in Cryptoglandular Fistulas

Collagen anal fistula plug treatment of transsphincteric fistulas produces variable results. The purpose of our study was to determine whether long-tract fistulas (>4 cm) correlated with successful closure. All patients undergoing transsphincteric cryptoglandular fistula repair with anal fistula plugs were enrolled in a prospective database. Patients with Crohn's disease were excluded. Fistula tract length was measured intraoperatively by subtracting the remaining plug length from the original plug size. All procedures used standardized techniques and postoperative care pathways. The primary outcome was complete fistula closure assessed through both postoperative outpatient visits and a follow-up telephone questionnaire. Forty-one patients with 42 fistula tracks were enrolled over a 39-month period. Complete closure was achieved in 18 of 42 (43%) fistulas at a mean follow-up of 25 months. Closure was not associated with gender, age, tract location, duration of seton, or length of follow-up. Successful closure was significantly associated with increased tract length, because fistulas longer than 4 cm were nearly 3 times more likely to heal compared with shorter fistulas ((14/23, 61%) vs (4/19, 21%), P = .004; relative risk = 2.8; 95% CI 1.14-7.03). Anal fistula plug repair of cryptoglandular anorectal fistulas is more successful for long-tract fistulas. Although the overall success is modest, limiting surgical indications to fistulas exceeding 4 cm may maximize benefits of the plug technique.

Anal fistula plug is a valid alternative option for the treatment of complex anal fistula in the long term

This prospective, two-centre study was designed to evaluate long-term outcomes when using a collagen plug to treat cryptoglandular anal fistulae. Over 3 years, 60 consecutive patients with cryptoglandular fistulae were treated using an anal fistula plug by experienced surgeons. Preoperative, postoperative and follow-up data were collected in a dedicated database. Success was defined as the closure of all fistula openings and the absence of discharge. Faecal incontinence scores were administered at baseline and at 6 months follow-up. Eleven patients had multiple fistula tracts. All fistulae treated in this series were classified as complex. Seventeen fistulae were anterior tracts in females, and the remaining tracts were trans-sphincteric in nature. Thirty-eight tracts were recurrent. Mean operative time was 26 ± 10 min. No major complications, active sepsis or mortality were observed. Success rate with a mean follow-up of 13 months was 60% of patients and 70% of tracts. Mean time for recurrence was 5.7 months. Two recurrent patients were successfully treated with a redo plug procedure, and five were successfully closed with a post-plug fistulotomy, leading to a global 72% success rate without continence impairment. Of the patients with a minimum follow-up of 6 months (mean, 18.5 months; range, 6-34 months), 29 in 32 (90.6%) were healed at final evaluation. In these patients, the mean preoperative CCF incontinence score was 0.73. This was reduced to 0.14 at 6-month follow-up. The mean reduction of CCF incontinence score was -0.6 (95% CI, 1.3 to -0.1; p = 0.01). Fistula tract treatment with the anal fistula plug is a safe and viable surgical option that should be offered to complex fistula patients. The reasons and risk factors for recurrence remain to be explored.