Anal Fistula Plug Research Articles

Anal Fistula Plug

This study was designed to analyze the efficacy of the Cook Surgisis AFP anal fistula plug for the management of complex anal fistulas. This was a retrospective review of all patients prospectively entered into a database at our institution who underwent treatment for complex anal fistulas using Cook Surgisis AFP anal fistula plug between July 2005 and July 2006. Patient's demographics, fistula etiology, and success rates were recorded. The plug was placed in accordance with the inventor's guidelines. Success was defined as closure of all external openings, absence of drainage without further intervention, and absence of abscess formation. Thirty-five patients underwent 39 plug insertions (22 men; mean age, 46 (range, 15-79) years). Three patients were lost to follow-up, therefore, 36 procedures to be analyzed. The fistula etiology was cryptoglandular in 31 (88.6 percent) patients and Crohn's disease associated in the other 4 (11.4 percent). There were 11 smokers and 3 patients with diabetes. The mean follow-up was 126 days (standard = 69.4). The overall success rate was 5 of 36 (13.9 percent). One of the four Crohn's disease-associated fistulas healed (25 percent) and 4 of 32 (12.5 percent) procedures resulted in healing of cryptoglandular fistulas. In 17 patients, further procedures were necessary as a result of failure of treatment with the plug. The reasons for failure were infection requiring drainage and seton placement in 8 patients (25.8 percent), plug dislodgement in 3 (9.7 percent), persistent drainage/tract and need for other procedures in 20 patients (64.5 percent). The success rate for Surgisis AFP anal fistula plug for the treatment of complex anal fistulas was (13.9 percent), which is much lower than previously described. Further analysis is needed to explain significant differences in outcomes.

Flaps, Glues, and Plugs—A View From the East

Complex fistulas are difficult to treat. The options available are advancement flaps, fibrin glue, and, of late, anal fistula plug (AFP). A sizable proportion of the published studies are from the US and Europe. The results from these studies were analyzed and compared to the results of the published literature from the east (Asia and Australia). The overall success rate ranges from 46% to 100% for advancement flaps, 14% to 78% for fibrin glue, and 24% to 87% for AFP technique. However, the present data is insufficient to conclude the superiority of either (ie, fibrin glue or AFP procedure) over the other. So, depending on the surgeon's preference, either of the two procedures may be recommended as the first line of approach to tackle complex fistulas. Advancement flap procedure is associated with higher morbidity and involves a significant risk of incontinence/worsening continence (0%-52%). Therefore, under the circumstances, advancement flap procedure should probably be recommended only after the lesser invasive procedures (fibrin glue and AFP) have failed.

Anal Fistula Plug: A European Perspective

Impressed by the initial success rates (80%) of the Cook Surgisis AFP anal fistula plug for the closure of both cryptoglandular and Crohn's associated anorectal fistulas, the preliminary results from Europe showed healing rates of 41% and 61%, respectively. However, no impairment of continence was documented. Analyzing the current experiences of the plug procedure from a German perspective, a variety of issues are under debate including the role of bowel preparation, treatment of fistula tract, closure of the internal opening, postoperative management, and, finally, financial reimbursement. Furthermore, the ideal indication has to be defined. In general, the introduction of the plug has accelerated a new discussion on the optimal treatment of high anorectal fistulas. Further analysis is needed to explain the definite role of this innovative technique in comparison to traditional surgical techniques, particularly whether the plug can offer the biological properties required for permanent fistula healing. Consequently—as a European perspective—the randomized German multicenter study comparing the plug procedure vs. advancement flap repair for transsphincteric fistulas will hopefully elucidate the definite role of the plug.

Treatment of Transsphincteric Anal Fistulas by Endorectal Advancement Flap or Collagen Fistula Plug

In this study we compared the outcomes of patients with complex cryptoglandular fistulas treated by endorectal advancement flap or anal fistula plug. We performed a retrospective analysis of patients with transsphincteric anal fistulas treated by endorectal advancement flap or anal fistula plug from January 1996 through April 2007. Patients with noncryptoglandular fistulas or insufficient follow-up were excluded. Results were obtained with a combination of chart reviews, mailed questionnaire, and phone interviews. Success was defined as a closed external opening in absence of symptoms at a minimal follow-up time of six months. Forty-three patients had an endorectal advancement flap and 37 patients had an anal fistula plug procedure. The two cohorts were comparable for age, gender, smoking status, fistula type, and previous failed treatments. The success rate was 63 percent in the endorectal advancement flap group and 32 percent in the anal fistula plug group (P = 0.008), after a mean follow-up of 56 (range, 6-136) months for endorectal advancement flap and 14 (range, 6-22) months for anal fistula plug. The current study indicates that the endorectal advancement flap provides a higher success rate than the anal fistula plug. Randomized trials are needed to further elucidate the efficacy and potential functional benefit of the anal fistula plug in the treatment of complex anal fistulas.

The Anal Fistula Plug versus the mucosal advancement flap for the treatment of Anorectal Fistula (PLUG trial)

BackgroundLow transsphincteric fistulas less than 1/3 of the sphincter complex are easy to treat by fistulotomy with a high success rate. High transsphincteric fistulas remain a surgical challenge. Various surgical procedures are available, but recurrence rates of these techniques are disappointingly high. The mucosal flap advancement is considered the gold standard for the treatment of high perianal fistula of cryptoglandular origin by most colorectal surgeons. In the literature a recurrence rate between 0 and 63% is reported for the mucosal flap advancement. Recently Armstrong and colleagues reported on a new biologic anal fistula plug, a bioabsorbable xenograft made of lyophilized porcine intestinal submucosa. Their prospective series of 15 patients with high perianal fistula treated with the anal fistula plug showed promising results.The anal fistula plug trial is designed to compare the anal fistula plug with the mucosal flap advancement in the treatment of high perianal fistula in terms of success rate, continence, postoperative pain, and quality of life.Methods/designThe PLUG trial is a randomized controlled multicenter trial. Sixty patients with high perianal fistulas of cryptoglandular origin will be randomized to either the fistula plug or the mucosal advancement flap. Study parameters will be anorectal fistula closure-rate, continence, post-operative pain, and quality of life. Patients will be followed-up at two weeks, four weeks, and 16 weeks. At the final follow-up closure rate is determined by clinical examination by a surgeon blinded for the intervention.DiscussionBefore broadly implementing the anal fistula plug results of randomized trials using the plug should be awaited. This randomized controlled trial comparing the anal fistula plug and the mucosal advancement flap should provide evidence regarding the effectiveness of the anal fistula plug in the treatment of high perianal fistulas.Trial registrationISRCTN: 97376902

Treatment of Complex Anal Fistulas with the Collagen Fistula Plug

Anal fistulas that involve a significant amount of sphincter may be difficult to treat without compromising continence function. In this study, we evaluated our experience with the Surgisis anal fistula plug, which was recently reported to be successful in >80 percent of patients with complex fistulas. We retrospectively collected patient and fistula characteristics, procedure details, and follow-up information for all patients treated with the anal fistula plug at our institution from January 2006 through April 2007. The outcome was considered successful if the external opening was closed and if the patient had no drainage at the last follow-up. Using multivariate statistics, we analyzed the relationship between anal fistula plug success and several key variables. From January 2006 through April 2007, 47 patients with 49 complex anal fistulas underwent 64 anal fistula plug procedures. The median follow-up time for patients who were considered healed was 6.5 (range, 3-11) months. The success rate was 31 percent per procedure and 43 percent per patient. An increased amount of external sphincter involvement was associated with a higher failure rate (P < 0.05). In our early experience with the anal fistula plug, 43 percent of patients with complex anal fistulas were successfully treated. Patients with less external sphincter involvement were more likely to heal.

Early Experience with the Bioabsorbable Anal Fistula Plug

Management of anal fistula represents a balance between curing the condition and maintaining anal continence. Recent reports of the results of the porcine anal fistula plug have demonstrated excellent fistula healing rates without reporting significant complications. The outcome of patients who underwent treatment for anal fistula with the Surgisis anal plug was retrospectively reviewed. Twenty patients were treated; three underwent concomitant anal advancement flap at the time of plug placement. Seventeen patients had a trans-sphincteric fistula, and three had an anoperineal fistula. Ten patients had previously undergone failed surgical therapy to cure their fistula, including anal advancement flap in four, muscle interposition flap in two, fistulotomy in two, and cutting seton placement in two. Mean follow-up was 7.4 months. Only 4 of 17 (24%) patients treated with the plug alone had closure of their fistula. Acute postoperative sepsis was seen in 5 of 17 (29%) patients treated with the plug alone. Four developed perianal abscesses that required incision and drainage, and one intersphincteric abscess was treated with antibiotics. Two of the patients who underwent concomitant anal advancement flaps and plug placement healed successfully. Contrary to other published series, the use of the Surgisis anal plug was associated with a low rate of fistula healing and a high incidence of perianal sepsis. The addition of a transanal advancement flap to the procedure may improve success rates.

Collagen Fistula Plug for the Treatment of Anal Fistulas

This study was designed to evaluate the efficacy of the Surgisis (Anal Fistula Plug) in multiple patients at our institution and present early clinical results along with notable clinical observations from our experience. This was a prospective analysis of all patients who received the Anal Fistula Plug for treatment of anorectal fistulas between April 2006 and February 2007. All tracts were irrigated with peroxide, the plug was inserted in the tract, and buried at the internal opening with 2-0 vicryl and mucosal advancement flap. Statistical analysis was performed with Fisher's exact test. Forty-five patients were treated with the Anal Fistula Plug and one patient was lost to follow-up. There were 27 males and 17 females with average age of 44.1 years treated for simple (n = 24) or complex (n = 20) fistulas. Preliminary results indicated an 84 percent healing rate by 3 to 8 weeks postoperatively, which progressively declined from 72.7 percent at 8 weeks to 62.4 percent at 12 weeks and 54.6 percent at a median follow-up of 6.5 (range, 3-13) months. Long-term Anal Fistula Plug closure rate was significantly higher in patients with simple than complex fistulas (70.8 vs. 35 percent; P < 0.02) and with non-Crohn's disease vs. Crohn's disease (66.7 vs. 26.6 percent; P < 0.02). Patients with two successive plug placements had significantly lower closure rates than patients who underwent placement of the plug once (12.5 vs. 63.9 percent; P < 0.02). No significant difference in closure rates were found between patients with one vs. multiple fistula tracts. Postoperative complications included perianal abscess in five patients (3 Crohn's disease, 2 non-Crohn's disease). Anal Fistula Plug is most successful in the treatment of simple anorectal fistulas but is associated with a high failure rate in complex fistula and particularly in patients with Crohn's disease. Repeat plug placement is associated with increased failure. Given the relatively low morbidity associated with the procedure, Anal Fistula Plug should be considered as a first-line treatment for patients with simple fistulas and as an alternative in selected patients with complex fistulas.

Acellular extracellular matrix anal fistula plug: Results in high fistula-in-ano awaited

Song et al have reported a 100% success rate of acellular extracellular matrix (AEM) anal fistula plug in low fistula-in-ano. The results with this product in high fistula-in-ano are keenly awaited.

A anorectal fistula treatment with acellular extracellular matrix: A new technique

To investigate a new technique of the anorectal fistula treatment with acellular extracellular matrix (AEM). Thirty patients with anorectal fistula were treated with AEM. All fistula tracts and primary openings were identified using conventional fistula probe. All tracts were curetted with curet and irrigated with hydrogen peroxide and metronidazole. The AEM was pulled into the fistula tract from secondary to primary opening. The material was secured at the level of the primary opening. The excess AEM was trimmed at skin level at the secondary opening. All of the 30 patients had successful closure of their fistula after a 7-14 d follow-up. The healing rate of anal fistula in treatment group was 100%. The ache time, healing time and anal deformation of treatment group were obviously superior to traditional surgical methods. Using AEM anal fistula plug in treatment that causes the anorectal fistula is safe and successful in 100% of patients. It can reduce pain, shorten disease course and protect anal function.

Initial experience on efficacy in closure of cryptoglandular and Crohn’s transsphincteric fistulas by the use of the anal fistula plug

It was the aim of this prospective study to analyze the efficacy of the Cook Surgisis AFP anal fistula plug (AFP) for the closure of cryptoglandular and Crohn's disease-associated transsphincteric anorectal fistulas. All patients with transsphincteric anorectal fistulas who underwent a surgical procedure using the AFP were prospectively enrolled in this study. Inclusion criteria included transsphincteric, single-tract fistulas. Patients' demographics, fistula etiology, surgical variables, continence (Cleveland Clinic Florida incontinence score), quality of life (fecal incontinence quality of life), and success rates were prospectively recorded. Surgery was performed in a standardized technique including irrigation of the fistula tract, placement, and internal fixation of the Cook Surgisis AFP anal fistula plug. No flap or excision of the fistula tract was performed. Success was defined as closure of both internal and external openings, absence of drainage without further intervention, and absence of abscess formation. Follow-up information was derived from clinical examination 3, 6, 9, and 12 months postoperatively. Within 6 months (August 2006 to January 2007), a total of 19 AFPs were inserted in 19 patients (8 females, 11 males; mean age, 38 years). Out of 19 patients, 12 had cryptoglandular and 7 had Crohn's associated transsphincteric fistulas. Three patients were smokers, one patient had methicillin-resistant Staphylococcus aureus infection. Mean operative time was 15 min (range, 8-22); no morbidity occurred. After a mean follow-up of 279 days (SD = 68.0) and one patient lost to follow-up, the overall success rate was 61% (12 of 18) at 9 months postoperatively. Focusing solely on cryptoglandular fistulas, the success rate was 45.5% (5 of 11), whereas it was 85.7% (6 of 7) in transsphincteric fistulas associated with Crohn's disease. Five patients with failure of AFP (plug dislodgement, n = 2; persistent secretion, n = 3) had reoperation (27.8%). The reasons for failure were infection requiring drainage (n = 2) and persistent drainage (n = 3). No deterioration of continence was documented. The success rate for the Cook Surgisis AFP anal fistula plug for the closure of complex anorectal fistulas both in cryptoglandular and Crohn's associated fistulas was 45.5 and 85.7%, respectively. Further analysis is needed to explain the definite role of this innovative technique in comparison to traditional surgical techniques.

The surgisis® AFP™ anal fistula plug: report of a consensus conference*

The surgisis^® AFP^™ anal fistula plug: report of a consensus conference*

Anal Fistula Plug for Closure of Difficult Anorectal Fistula: A Prospective Study

Complex high and recurrent fistulas remain a surgical challenge. Simple division, i.e., fistulotomy, will likely result in fecal incontinence. Various surgical treatment options for these fistulas have shown disappointing results. Recently a biologic anal fistula plug was developed to treat these high transsphincteric fistulas. To assess the results of the anal fistula plug in patients with complex high perianal fistulas, a prospective, two-center, clinical study was undertaken. Between April 2006 and October 2006, a consecutive series of patients with difficult therapy-resistant high fistulas were enrolled. During surgery, the internal fistula tract opening was identified. A conical shaped collagen plug was pulled through the fistula tract. Any remaining portion of the plug that was not implanted in the tract was removed. The plug was fixed at the internal opening with a deep 3/0 polydioxanone suture. Seventeen patients with a median age of 45 (range, 27-75) years were included. Of these patients, 71 percent (12/17) were male. At a median length of follow-up of 7 (range, 3-9) months, 7 of 17 fistulas had healed (41 percent). In ten patients, the fistula recurred. In these small series of 17 patients with difficult high perianal fistulas, a success rate of 41 percent is noted. Larger series, preferably in trial setting, must be performed to establish the efficacy of the anal fistula plug in perianal fistula.

Bronchopleural Fistula Repair During Clagett Closure Utilizing a Collagen Matrix Plug

We describe a 65-year-old man who was treated for an empyema after a right middle and lower lobectomy for adenocarcinoma with a Clagett procedure who subsequently had a bronchopleural fistula develop. After adequate debridement of the cavity through dressing changes, the right bronchus intermedius bronchopleural fistula was closed using a collagen porcine plug (Surgisis anal fistula plug [Cook Medical Inc, Bloomington, IN]) placed through the cavity into the fistula along with the placement of omentum into the cavity. This case report illustrates the utility of collagen plugs to close bronchopleural fistulas.

Efficacy of Anal Fistula Plug in Closure of Cryptoglandular Fistulas: Long-Term Follow-Up

The long-term efficacy of Surgisis anal fistula plug in closure of cryptoglandular anorectal fistulas was studied. Patients with high cryptoglandular anorectal fistulas were prospectively studied. Additional variables recorded were: number of fistula tracts, and presence of setons. Under general anesthesia and in prone jackknife position, patients underwent irrigation of the fistula tract by using hydrogen peroxide. Each primary opening was occluded by using a Surgisis anal fistula plug, which was securely sutured in place at the primary opening and tacked to the periphery of the secondary opening. Forty-six patients were prospectively enrolled during a two-year period. Follow-up was six months to two years (median, 12 months). At final follow-up, all fistula tracts had been successfully closed in 38 patients, for an overall success rate of 83 percent. Seven patients had multiple tracts, for a total of 55 fistula tracts in the series. Of the 55 individual tracts, 47 (85 percent) were closed at final follow-up. Patients with one primary opening were most likely to have successful closure by using the anal fistula plug, although this was not significant. Successful closure was not correlated with the presence of setons. Long-term closure of cryptoglandular anorectal fistula tracts using Surgisis anal fistula plug is safe and successful in 83 percent of patients and 85 percent of tracts.

Efficacy of Anal Fistula Plug in Closure of Crohn's Anorectal Fistulas

The efficacy of Surgisis anal fistula plug in closure of Crohn's anorectal fistula was studied. Patients with Crohn's anorectal fistulas were prospectively studied. Diagnosis was made by histologic, radiographic, or endoscopic criteria. Variables recorded were: number of fistula tracts (primary openings), presence of setons, and current antitumor necrosis factor therapy. Under general anesthesia and in prone jackknife position, patients underwent irrigation of the fistula tract by using hydrogen peroxide. Each primary opening was occluded by using a Surgisis anal fistula plug. Superficial tracts amenable to fistulotomy were excluded. Twenty consecutive patients were prospectively enrolled, comprising a total of 36 fistula tracts. At final follow-up, all fistula tracts had been successfully closed in 16 of 20 patients, for an overall success rate of 80 percent. Thirty of 36 individual fistula tracts (83 percent) were closed at final follow-up. Patients with single fistulas (with 1 primary opening) were most likely to have successful closure using the anal fistula plug. Successful closure was not correlated with the presence of setons or antitumor necrosis factor therapy. Closure of Crohn's anorectal fistula tracts using Surgisis anal fistula plug is safe and successful in 80 percent of patients and 83 percent of fistula tracts. Closure rates were higher with single tracts than complex fistulas with multiple primary openings.

Efficacy of Anal Fistula Plug vs. Fibrin Glue in Closure of Anorectal Fistulas

Long-term closure rates of anorectal fistulas using fibrin glue have been disappointing, possibly because of the liquid consistency of the glue. A suturable bioprosthetic plug (Surgisis, Cook Surgical, Inc.) was fashioned to close the primary opening of fistula tracts. A prospective cohort study was performed to compare fibrin glue vs. the anal fistula plug. Patients with high transsphincteric fistulas, or deeper, were prospectively enrolled. Patients with Crohn's disease or superficial fistulas were excluded. Age, gender, number and type of fistula tracts, and previous fistula surgeries were compared between groups. Under general anesthesia and in prone jackknife position, the tract was irrigated with hydrogen peroxide. Fistula tracts were occluded by fibrin glue vs. closure of the primary opening using a Surgisis anal fistula plug. Twenty-five patients were prospectively enrolled. Ten patients underwent fibrin glue closure, and 15 used a fistula plug. Patient's age, gender, fistula tract characteristics, and number of previous closure attempts was similar in both groups. In the fibrin glue group, six patients (60 percent) had persistence of one or more fistulas at three months, compared with two patients (13 percent) in the plug group (P < 0.05, Fisher exact test). Closure of the primary opening of a fistula tract using a suturable biologic anal fistula plug is an effective method of treating anorectal fistulas. The method seems to be more reliable than fibrin glue closure. The greater efficacy of the fistula plug may be the result of the ability to suture the plug in the primary opening, therefore, closing the primary opening more effectively. Further prospective, long-term studies are warranted.