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1.  Gore BioA Fistula Plug in the treatment of high anal fistulas – initial results from a German multicenter-study 
GMS German Medical Science  2012;10:Doc13.
Background: Treatment of high anal fistulas may be associated with a high risk of continence disorders. Beside traditional procedure of flap-reconstruction the occlusion of the fistula tract using fistula-plugs offers a new sphincter-saving treatment option. In this study for the first time results from Germany are described.
Patients and method: 40 patients (30 male, 10 female, age 51±12 years) underwent closure of a high trans-sphincteric (n=28) or supra-sphincteric (n=12) fistula with Gore BioA Fistula Plug® in three surgical departments. The surgical procedures had been performed by five colorectal surgeons. Four patients had Crohn’s disease. Preoperatively 33 patients were completely continent; seven patients complained of minor continence disorders. Treatment of the patients was performed on a intent-to-treat basis and evaluation of the results was retrospective using pooled data from each center.
Results: Postoperatively one patient developed an abscess, which had to be managed surgically. In two patients the plug had fallen out within the first two weeks postoperatively. Six months after surgery the fistula has been healed in 20 patients (50.0%). Three additional fistulas healed after 7, 9 rsp. 12 months. The overall healing-rate was 57.5% (23/40). The healing rate differs considerably between the surgeons from 0 to 75% and depends on the number of previous interventions. In patients having only drainage of the abscess success occurred in 63.6% (14/22) whereas in patients after one or more flap fistula reconstruction the healing rate decreased slightly to 50% (9/18). No patient complained about any impairment of his preoperative continence status.
Conclusion: By occlusion of high anal fistulas with a plug technique definitive healing could be achieved in nearly every second patients. Previous surgery seems to have a negative impact on success rate. We have not observed any negative impact on anal continence. From that point of view anal fistula plugs might be discussed as a treatment option for high anal fistulas, but further studies are needed to gain conclusive evidence.
PMCID: PMC3440842  PMID: 22984363
complex fistula-in-ano; transsphincteric fistula; suprasphincteric fistula; surgical procedures; fecal incontinence; fistula plug
2.  Treatment of Crohn’s disease-related high perianal fistulas combining the mucosa advancement flap with platelet-rich plasma: a pilot study 
Techniques in Coloproctology  2015;19(8):455-459.
Healing rates after surgical closure for high perianal fistula in patients with Crohn’s disease are even more disappointing than in patients with cryptoglandular fistulas. The objective was to improve healing rates by combining the well-known mucosal advancement flap with platelet-rich plasma.
A prospective pilot study was conducted in one tertiary referral centre. Consecutive patients with primary or recurrent Crohn’s disease-related high perianal fistulas, defined as involving the middle and/or upper third parts of the anal sphincter complex, were included. A staged procedure was performed with non-cutting seton treatment for 3 months first, followed by a mucosal advancement flap with injection of platelet-rich plasma into the fistula tract.
Ten consecutive patients were operated on between 2009 and 2014. Half (50 %) of the patients had undergone previous fistula surgery. Mean follow-up was 23.3 months (SD 13.0). Healing of the fistula was 70 % (95 % confidence interval, 33–89 %) at 1 year. One (10 %) patient had a recurrence, and in two (20 %) patients, the fistula was persistent after treatment. An abscess occurred in one (10 %) patient. The median post-operative Vaizey score was 8.0 (range 0–21), indicating a moderate to severe continence impairment.
The results of combining the mucosal advancement flap with platelet-rich plasma in patients with Crohn’s disease-related high perianal fistulas are moderate with a healing rate of 70 %. Further investigation is needed to determine the benefits and risks on continence status for this technique in this patient population.
PMCID: PMC4513214  PMID: 25975971
Mucosal advancement flap; Platelet-rich plasma; High perianal fistula; Recurrence; Crohn’s disease
3.  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.
PMCID: PMC3160532  PMID: 21876616
Fistula; Abscess; Fibrin sealant; Anal fistula plug; Dermal advancement flap; Endorectal flap; Ligation of intersphincteric fistula tract procedure
4.  Fibrin glue and transanal rectal advancement flap for high transsphincteric perianal fistulas; is there any advantage? 
Backgrounds and aim
In recent decades, fibrin glue has appeared as an alternative treatment for high perianal fistulas. Early results seemed promising, with high success rates being reported. However, with increasing follow-up, the enthusiasm was tempered because of disappointing results. The aim of this retrospective study was to assess the additional value of fibrin glue in combination with transanal advancement flap, compared to advancement flap alone, for the treatment of high transsphincteric fistulas of cryptoglandular origin.
Materials and methods
Between January 1995 and January 2006, 127 patients were operated for high perianal fistulas with an advancement flap. After exclusion of patients with inflammatory bowel disease or HIV, 80 patients remained. A consecutive series of 26 patients had an advancement flap combined with obliteration of the fistula tract with fibrin glue. Patients were matched for prior fistula surgery, and the advancement was performed identically in all patients. In the fibrin glue group, glue was installed retrogradely in the fistula tract after the advancement was completed and the fistula tract had been curetted.
Minimal follow-up after surgery was 13 months [median of 67 months (range, 13–127)]. The overall recurrence rate was 26% (n = 21). Recurrence rates for advancement flap alone vs the combination with glue were 13% vs 56% (p = 0.014) in the group without previous fistula surgery and 23% vs 41% (p = 0.216) in the group with previous fistula surgery.
Obliterating the fistula tract with fibrin glue was associated with worse outcome after rectal advancement flap for high perianal fistulas.
PMCID: PMC2386753  PMID: 18322659
Rectal fistula; Surgery; Recurrence; Fibrin glue; Advancement
5.  Surgery for fistula-in-ano in a specialist colorectal unit: a critical appraisal 
BMC Gastroenterology  2011;11:120.
Several techniques have been described for the management of fistula-in-ano, but all carry their own risks of recurrence and incontinence. We conducted a prospective study to assess type of presentation, treatment strategy and outcome over a 5-year period.
Between 1st January 2005 and 31st March 2011 247 patients presenting with anal fistulas were treated at the University Hospital Tor Vergata and were included in the present prospective study. Mean age was 47 years (range 16-76 years); minimum follow-up period was 6 months (mean 40, range 6-74 months).
Patients were treated using 4 operative approaches: fistulotomy, fistulectomy, seton placement and rectal advancement flap. Data analyzed included: age, gender, type of fistula, operative intervention, healing rate, postoperative complications, reinterventions and recurrence.
Etiologies of fistulas were cryptoglandular (n = 218), Crohn's disease (n = 26) and Ulcerative Colitis (n = 3). Fistulae were classified as simple -intersphincteric 57 (23%), low transphincteric 28 (11%) and complex -high transphicteric 122 (49%), suprasphincteric 2 (0.8%), extrasphinteric 2 (0.8%), recto-vaginal 7 (2.8%) Crohn 26 (10%) and UC 3 (1.2%).
The most common surgical procedure was the placement of seton (62%), usually applied in case of complex fistulae and Crohn's patients.
Eighty-five patients (34%) underwent fistulotomy, mainly for intersphincteric and mid/low transphincteric tracts. Crohn's patients were submitted to placement of one or more loose setons.
The main treatment successfully eradicated the primary fistula tract in 151/247 patients (61%). Three cases of major incontinence (1.3%) were detected during the follow-up period; Furthermore, three patients complained minor incontinence that was successfully treated by biofeedback and permacol injection into the internal anal sphincter.
This prospective audit demonstrates an high proportion of complex anal fistulae treated by seton placement that was the most common surgical technique adopted to treat our patients as a first line. Nevertheless, a good outcome was achieved in the majority of patients with a limited rate of faecal incontinence (6/247 = 2.4%). New technologies provide promising alternatives to traditional methods of management particularly in case of complex fistulas. There is, however, a real need for high-quality randomized control trials to evaluate the different surgical and non surgical treatment options.
PMCID: PMC3235969  PMID: 22070555
6.  The Role of Fibrin Glue in the Treatment of High and Low Fistulas in Ano 
Aim: The aim of this study was to assess the outcome of fibrin glue in high and low anal fistulas.
Methods: A prospective, non-randomized trial was carried out on 30 patients who were diagnosed to have fistulas in ano. They were evaluated by categorizing them into high (with the internal opening above the anorectal ring)(14/30) and low anal fistulas (with the internal opening below the anorectal ring)(16/30). The fibrin glue was instilled in their anal tracts. The character of the anal tract, whether it was single or multiple and primary or recurrent, was analyzed. The outcome in terms of a postoperative discharge (failure), the incidence of a postoperative perianal pain/abscess and the glue reaction, was noted at 1 week, 1 month, 3 months and 6 months. A success was defined as the absence of any discharge at 6 months.
Results: Fourteen patients with high anal fistulas and 16 with low anal fistulas (with a mean age of 48.5yrs) were treated with fibrin glue. 19 patients had primary tracts (7- high group and 12- low group) and 11 had recurrent tracts (7- high group and 4- low group). 20 fistulas were single tracted (8- high and 12- low) and ten were multiple tracted (6- high and 4-low). The success rate at 6 months was 57.14% in the high group and it was 81.25% in the low group. The failure rate was 85.71% in the recurrent high fistula group as compared to 25% in the recurrent low fistula group (p=0.049). 25% of the single tracted high fistulas failed to heal as compared to a 100% healing rate in the single low fistulas group (p=0.90).
Conclusion: This procedure is thus, superior to the conventional surgical treatment, in terms of the patient comfort, an undisturbed sphincter function, a reduced overall hospital stay, wound pain and the complications and adverse reactions. It showed the best results in the primary, single tracted and the low anal fistulas.
PMCID: PMC3681059  PMID: 23814732
Fistula in ano; Fibrin glue; Failed fistula; Recurrenct fistula
7.  Modified Plug Repair with Limited Sphincter Sparing Fistulectomy in the Treatment of Complex Anal Fistulas 
Frontiers in Surgery  2014;1:17.
Purpose: New technical approaches involving biologically derived products have been used to treat complex anal fistulas in order to avoid the risk of fecal incontinence. The least invasive methods involve filling out the fistula tract with fibrin glue or introduction of an anal fistula plug into the fistula canal following thorough curettage. A review shows that the new techniques involving biologically derived products do not confer any significant advantages. Therefore, the question inevitably arises as to whether the combination of a partial or limited fistulectomy, i.e., of the extrasphincteric portion of the fistula, and preservation of the sphincter muscle by repairing the section of the complex anal fistula running through the sphincter muscle and filling it with a fistula plug produces better results.
Methods: A modified plug technique was used, in which the extrasphincteric portion of the complex anal fistula was removed by means of a limited fistulectomy and the remaining section of the fistula in the sphincter muscle was repaired using the fistula plug with fixing button.
Results: Of the 52 patients with a complex anal fistula, who had undergone surgery using a modified plug repair with limited fistulectomy of the extrasphincteric part of the fistula and use of the fistula plug with fixing button, there are from 40 patients (follow-up rate: 77%) some kind of follow-up informations, after a mean of 19.32 ± 6.9 months. Thirty-two were men and eight were women, with a mean age of 52.97 ± 12.22 years. Surgery was conducted to treat 36 transsphincteric, 1 intersphincteric, and 3 rectovaginal fistulas. In 36 of 40 patients (90%), the complex anal fistulas or rectovaginal fistulas were completely healed without any sign of recurrence. None of these patients complained about continence problems.
Conclusion: A modification of the plug repair of complex anal fistulas with limited fistulectomy of the extrasphincteric part of the fistula and use of the plug with fixing button seems to increase the healing rate in comparison to the standard plug technique.
PMCID: PMC4287161  PMID: 25593941
anal fistula; plug repair; sphincter sparing fistulectomy; fistula plug; biological plug
8.  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.
PMCID: PMC3140329  PMID: 22379401
Fistula; abscess; anorectal infection; sphincterotomy; fecal incontinence
9.  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.
PMCID: PMC3296947  PMID: 22413076
Anal fistula; Rectal fistula; Fecal incontinence
10.  Current management of anal fistulas in Crohn's disease 
Anal fistulas occurring in Crohn's disease (CD) comprise a risk factor of severe course of inflammation. They are frequently intractable due to various factors such as penetration of the anal canal or rectal wall, impaired wound healing, and immunosuppression, among others. Anal fistulas typical to CD develop from fissures or ulcers of the anal canal or rectum. Accurate identification of the type of fistula, such as low and simple or high and complex, is crucial for prognosis as well as for the choice of treatment. If fistulotomy remains the gold standard in the surgical treatment of the former, it is contraindicated in high and complex fistulas due to possible risk of damage to the anal sphincter with subsequent faecal incontinence. Therefore, the latter require a conservative and palliative approach, such as an incision and drainage of abscesses accompanying fistulas or prolonged non-cutting seton placement. Currently, conservative, sphincter-preserving, and definitive procedures such as mucosal advancement or dermal island flaps, the use of plugs or glue, video assisted anal fistula treatment, ligation of the intersphincteric track, and vacuum assisted closure are gaining a great deal of interest. Attempting to close the internal opening without injuring the sphincter is a major advantage of those methods. However, both the palliative and the definitive procedures require adjuvant therapy with medical measures.
PMCID: PMC4631268  PMID: 26557938
Crohn's disease; anal fistula; combined therapy
11.  Treatment of Fistula-In-Ano with Fistula Plug – a Review Under Special Consideration of the Technique 
Frontiers in Surgery  2015;2:55.
In a recent Cochrane review, the authors concluded that there is an urgent need for well-powered, well-conducted randomized controlled trials comparing various modes of treatment of fistula-in-ano. Ten randomized controlled trials were available for analyses: There were no significant differences in recurrence rates or incontinence rates in any of the studied comparisons. The following article reviews the studies available for treatment of fistula-in-ano with a fistula plug with special attention paid to the technique.
Material and Methods
PubMed, Medline, Embase, and the Cochrane medical database were searched up to July 2015. Sixty-four articles were relevant for this review.
Healing rates of 50–60% can be expected for treatment of complex anal fistula with a fistula plug, with a plug-extrusion rate of 10–20%. Such results can be achieved not only with plugs made of porcine intestinal submucosa but also those made of other biological or synthetic bioabsorbable mesh materials. Important technical steps are firm suturing of the head of the plug in the primary opening and wide drainage of the secondary opening.
Treatment of a complex fistula-in-ano with a fistula plug is an option with a success rate of 50–60% with low complication rate. Further improvements in technique and better studies are needed.
PMCID: PMC4607815  PMID: 26528482
complex anal fistula; fistula plug; biological mesh; fistula closure rate; incontinence
12.  Fistula-in-Ano Complicated by Fournier's Gangrene Our Experience in North-Eastern Region of Nigeria 
Fistula-in-ano when complicated by Fournier's gangrene is an unusual finding and always carries high morbidity. This study details our experience in managing 10 cases.
Methods of Study:
Case files of all patients managed in University of Maiduguri Teaching Hospital and Federal Medical Center of Yola and Gombe from January, 2007 to December, 2011 were retrieved from Medical Record Departments and other Hospital Records. These were analyzed for demographic, clinical and pathological variables, the type of treatment and follow-up.
A total of 10 men with a mean age of 50.5 years (35-60) were managed in the period of study. Nearly, 50% of the patients were farmers, 30% businessmen and 20% were civil servant. 7 (70%) of these patients presented with Fournier's gangrene within 4 weeks of development of fistula-in-ano and the rest within 8 weeks. 4 (40%) of these patients had inadequate drainage of their perianal abscess and 2 (20%) had incision and drainage. Another 4 (40%) had spontaneously rupture of the perianal abscess. 6 (60%) of the fistula-in-ano was submuscular, 30% subcutaneous and 10% were complex or recurrent. Nearly, 20% of patients had fistulotomy and seton application for adequate drainage. Mucosal advancement flap was performed in 5 (50%) and fistulotomy in 3 (30%) patients. Another 30% had fistulotomy and continuing sitz bath.
Cryptoglandular infection is an important cause of perianal abscesses and fistula-in-ano and if poorly managed results in Fournier's gangrene. Early broad spectrum parenteral antibiotic therapy and primary surgical treatment can prevent Fournier's gangrene.
PMCID: PMC3899549  PMID: 24497752
Fistula-in-ano; Fournier's gangrene; perianal abscess
Anorectal fistula represents an epithelized communication path of infectious origin between the rectum or anal canal and the perianal region. The association of endoscopic surgery with the minimally invasive approach led to the development of the video-assisted anal fistula treatment.
To describe the technique and initial experience with the technique video-assisted for anal fistula treatment.
A Karl Storz video equipment was used. Main steps included the visualization of the fistula tract using the fistuloscope, the correct localization of the internal fistula opening under direct vision, endoscopic treatment of the fistula and closure of the internal opening which can be accomplished through firing a stapler, cutaneous-mucosal flap, or direct closure using suture.
The mean distance between the anal verge and the external anal orifice was 5.5 cm. Mean operative time was 31.75 min. In all cases, the internal fistula opening could be identified after complete fistuloscopy. In all cases, internal fistula opening was closed using full-thickness suture. There were no intraoperative or postoperative complications. After a 5-month follow-up, recurrence was observed in one (12.5%) patient.
Video-assisted anal fistula treatment is feasible, reproducible, and safe. It enables direct visualization of the fistula tract, internal opening and secondary paths.
PMCID: PMC4675488  PMID: 24676305
Rectal fistula; Surgical procedures; Minimally invasive; Fecal incontinence; Crohn's disease
14.  Management of an extrasphincteric fistula in an HIV-positive patient by using fibrin glue: a case report with tips and tricks 
BMC Gastroenterology  2010;10:18.
Individuals with impaired immunity are at higher risk of perianal diseases. Concerning complex anal fistulas impaired healing and complication rates are also higher. Definitive treatment of a fistula aims controlling the purulent discharge and prevents its recurrence. It depends mainly on the trajectory of the fistula and the underlying disease.
We present a case of a HIV-positive patient with a complex extrasphincteric anal fistula who was treated successfully with fibrin glue application. We further, discuss tips and tricks when applying fibrin glue as plugging material in complex anal fistulas.
Case presentation
A sixty-one-year-old HIV-positive male referred to us for warts and extrasphincteric fistula. Because of the patients' immunological status, we opted against surgery and recommended fibrin glue plugging. The patient was discharged the same day. A follow-up examination was performed 5 days after the initial fibrin glue application showing that the fistula canal was obstructed. Three months and a year post-intervention the fistula tract remains closed.
The best treatment for a disease gives at least the same result with the other treatments with minimised risk for the life of the patient and minimal application effort. Conservative closure of fistula with fibrin plugging is simple, safe and with less morbidity than surgery. Our patient was successfully treated without endangering his life despite his precarious medical state. Not everybody believes in the effectiveness of fibrin glue application, however we consider this solution in cases of complex fistulas at least as primary procedure in special populations such as the immunosupressed.
PMCID: PMC2829488  PMID: 20152052
15.  Fibrin glue in the treatment of anal fistula: a systematic review 
New sphincter-saving approaches have been applied in the treatment of perianal fistula in order to avoid the risk of fecal incontinence. Among them, the fibrin glue technique is popular because of its simplicity and repeatability. The aim of this review is to compare the fibrin glue application to surgery alone, considering the healing and complication rates.
We performed a systematic review searching for published randomized and controlled clinical trials without any language restriction by using electronic databases. All these studies were assessed as to whether they compared conventional surgical treatment versus fibrin glue treatment in patients with anal fistulas, in order to establish both the efficacy and safety of each treatment. We used Review Manager 5 to conduct the review.
The healing rate is higher in those patients who underwent the conventional surgical treatment (P = 0,68), although the treatment with fibrin glue gives no evidence of anal incontinence (P = 0,08). Furthermore two subgroup analyses were performed: fibrin glue in combination with intra-adhesive antibiotics versus fibrin glue alone and anal fistula plug versus fibrin glue. In the first subgroup there were not differences in healing (P = 0,65). Whereas in the second subgroup analysis the healing rate is statistically significant for the patients who underwent the anal fistula plug treatment instead of the fibrin glue treatment (P = 0,02).
In literature there are only two randomized controlled trials comparing the conventional surgical management versus the fibrin glue treatment in patients with anal fistulas. Although from our statistical analysis we cannot find any statistically significant result, the healing rate remains higher in patients who underwent the conventional surgical treatment (P = 0,68), and the anal incontinence rate is very low in the fibrin glue treatment group (P = 0,08). Anyway the limited collected data do not support the use of fibrin glue. Moreover, in our subgroup analysis the use of fibrin glue in combination with intra-adhesive antibiotics does not improve the healing rate (P = 0.65), whereas the anal fistula plug treatment compared to the fibrin glue treatment shows good results (P = 0,02), although the poor number of patients treated does not lead to any statistically evident conclusion. This systematic review underlines the need of new RCTs upon this issue.
PMCID: PMC2784785  PMID: 19912660
16.  Anal fistula plug vs mucosa advancement flap in complex fistula-in-ano: A meta-analysis 
AIM: 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.
METHODS: 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.
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.
CONCLUSION: 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.
PMCID: PMC3596507  PMID: 23494149
Complex anal fistula; Anal fistula plug; Mucosa advancement flap; Meta-analysis
17.  Staged Mucosal Advancement Flap versus Staged Fibrin Sealant in the Treatment of Complex Perianal Fistulas 
Background. In this prospective randomised study, the staged mucosal advancement flap is compared with staged fibrin sealant application in the treatment of perianal fistulas. Methods. All patients with high complex cryptoglandular fistulas were randomised to closure of the internal opening by a mucosal advancement flap (MF) or injection with fibrin sealant (FS) after treatment with setons. Recurrence rate and incontinence disorders were explored. Results. The MF group (5 females and 10 males) with a median age of 51 years and a median followup of 52 months. The FS group (4 females and 11 males) with a median age of 45 years and a median followup of 49 months. Three (20%) patients of the MF group had a recurrent fistula compared to 9 (60%) of the FS group (P = 0.03). No new continence disorders developed. Conclusion. Staged FS injection has a much lower success rate compared to MF.
PMCID: PMC3144662  PMID: 21808642
18.  Identification of epithelialization in high transsphincteric fistulas 
Techniques in Coloproctology  2012;16(2):113-117.
At present, transanal advancement flap repair (TAFR) is the treatment of choice for transsphincteric fistulas passing through the upper and middle third of the external anal sphincter. It has been suggested that epithelialization of the fistula tract contributes to the failure of the treatment. The aim of this study was to assess the prevalence of epithelialization of the fistula tract and to study its effect on the outcome of TAFR and TAFR combined with ligation of the intersphincteric fistula tract (LIFT).
Forty-four patients with a high transsphincteric fistula of cryptoglandular origin underwent TAFR. Nine of these patients underwent a combined procedure of TAFR with LIFT. In all patients the fistula tract was excised from the external opening up to the outer border of the external anal sphincter. In patients undergoing TAFR combined with LIFT an additional central part of the intersphincteric fistula tract was excised. A total of 53 specimens were submitted. Histopathological examination of the specimens was carried out by a pathologist, blinded for clinical data.
Epithelialization of the distal and intersphincteric fistula tract was observed in only 25 and 22% of fistulas, respectively. There was no difference in outcome between fistulas with or without epithelialization.
Epithelialization of high transsphincteric fistulas is rare and does not affect the outcome of TAFR and TAFR combined with LIFT.
PMCID: PMC3310980  PMID: 22231563
Transanal advancement flap repair; Ligation of the intersphincteric fistula tract; Transsphincteric fistulas; Epithelialization
19.  Update on anal fistulae: Surgical perspectives for the gastroenterologist 
Anal fistulae – abnormal connections between two epithelialized surfaces, such as between the intestine and the perianal skin – are relatively common, especially debilitating and can be very difficult to treat. In the majority of cases, they occur secondary to abscesses arising from infected anal glands, but can also be due to, among others, Crohn’s disease, trauma or tuberculosis. Traditionally, surgery has been the treatment of choice, not without, however, the inherent risk of complications. This review discusses fistulae classification, imaging, and traditional and current treatment options. Finally, a brief introduction to ongoing and new research in the treatment of fistulae is presented.
Anal fistulae are common and debilitating; they are characterized by severe pain and discharge. They arise following infection near the anal canal, or as a primary event from an abscess in the abdomen, fistulating into the vagina or perianal skin. The term ‘cryptoglandular’ is given to abscesses arising from the anal glands.
For many years, the treatment of choice was to lay open the fistula; however, this risks causing incontinence with potentially devastating consequences. Alternative surgical treatments include setons, fibrin glue, collagen plugs and flaps to cover the internal fistula opening. These have achieved varying degrees of success, as will be discussed. The present review also discusses anal fistulae in light of much recently published literature. Currently, anal fistulae remain challenging and require specialist expertise; however, new treatment options are on the horizon.
PMCID: PMC3266159  PMID: 22175058
Anal; Assessment; Fistula; Surgery; Treatment
20.  Multimodal treatment of perianal fistulas in Crohn’s disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial 
Trials  2015;16:366.
Currently there is no guideline for the treatment of patients with Crohn’s disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs.
This is a multicentre, randomized controlled trial. Patients with Crohn’s disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs.
The PISA trial is a multicentre, randomised controlled trial of patients with Crohn’s disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters.
Trial registration
Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).
Electronic supplementary material
The online version of this article (doi:10.1186/s13063-015-0831-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4545975  PMID: 26289163
Crohn’s disease; Perianal fistula; Seton; Anti-TNF; Advancement plasty; Quality of life; Cost-effectiveness
21.  Ligation of intersphincteric fistula tract: What is the evidence in a review? 
Broadly, complex fistulas are those that are not low transsphincteric or intersphincteric. The objectives of surgical management are to achieve fistula healing, prevent recurrences and maintain continence. The risk of incontinence associated with treatment ranges from 10% to 57%. The objective of this manuscript is to review the current literature to date on the ligation of the intersphincteric fistula tract procedure (LIFT procedure) as a treatment option in these types of fistula. A search was conducted in Medline, PUBMED, EMBASE and ISI Web of Knowledge, and studies published from January 2009 to May 2013 were included. The primary outcomes were fistula healing rates, mean healing time and patient satisfaction with this surgical technique. Eighteen studies were included in this review. The total number of patients included was 592 (65% male). The median age reported was 42.8 years. The most common type of fistula included was transsphincteric (73.3% of cases). The mean healing rate reported was 74.6%. The risk factors for failure discovered were obesity, smoking, multiple previous surgeries and the length of the fistula tract. The mean healing time was 5.5 wk, and the mean follow-up period was 42.3 wk. The patient satisfaction rates ranged from 72% to 100%. No de novo incontinence developed secondary to the LIFT procedure. There is not enough evidence that variants in the surgical technique achieve better outcomes (Bio-LIFT, LIFT-Plug, LIFT-Plus). This review indicates that the LIFT procedure is primarily effective for transsphincteric fistulas with an overall fistula closure of 74.6% and has a low impact on fecal continence. This procedure produces better outcomes at the first surgical attempt.
PMCID: PMC3812479  PMID: 24187455
Fistula-in-ano; Ligation; Intersphincteric; Fistula tract; Incontinence; Recurrence; Transsphincteric fistula
22.  The Nasal Artery Musculomucosal Cutaneous Flap in Difficult Palatal Fistula Closure 
Background After cleft palate repair is performed, oronasal fistulas are potential consequences with resultant regurgitation of fluid and food, hearing loss, and velopharyngeal insufficiency. Treatment of oronasal fistulas is a challenge for plastic surgeons especially when the fistulas are large and scarring is significant. The facial artery musculomucosal (FAMM) flap, introduced by Pribaz in 1992, is a reliable and useful procedure for the closure of wide palatal fistulas. A new modification of facial artery composite flap is presented here including a skin component that avoids extended procedures for nasal layer reconstruction and reduces the mucosal component size. The flap described here is the nasal artery musculomucosal (NAMMC) flap; the main blood supply comes from the lateral nasal artery, a terminal branch of facial artery.
Methods We present a series of anteriorly and posteriorly based NAMMC flaps, which were used to close large palatal fistulas after cleft palate repair in 12 patients.
Results All flaps were successful. One flap had an anterior wound dehiscence in a bilateral case, and we have seen no total flap failure or postoperative palatal fistulas. The aesthetic appearance of the skin donor site was acceptable in all cases.
Conclusions The NAMMC flap is a good alternative for closing wide and recurrent fistulas. It is associated with a high rate of success. The traditional FAMM flap should be named as “nasal (lateral) artery musculomucosal flap” because the distal branch of the facial artery is the main blood supply of the flap.
PMCID: PMC3578655  PMID: 23997862
facial artery flap; palatal fistulas
23.  A anorectal fistula treatment with acellular extracellular matrix: A new technique 
AIM: To investigate a new technique of the anorectal fistula treatment with acellular extracellular matrix (AEM).
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
PMCID: PMC2739342  PMID: 18720541
Acellular extracellular matrix; Anorectal fistula
24.  Modern management of anal fistula 
Ideal surgical treatment for anal fistula should aim to eradicate sepsis and promote healing of the tract, whilst preserving the sphincters and the mechanism of continence. For the simple and most distal fistulae, conventional surgical options such as laying open of the fistula tract seem to be relatively safe and therefore, well accepted in clinical practise. However, for the more complex fistulae where a significant proportion of the anal sphincter is involved, great concern remains about damaging the sphincter and subsequent poor functional outcome, which is quite inevitable following conventional surgical treatment. For this reason, over the last two decades, many sphincter-preserving procedures for the treatment of anal fistula have been introduced with the common goal of minimising the injury to the anal sphincters and preserving optimal function. Among them, the ligation of intersphincteric fistula tract procedure appears to be safe and effective and may be routinely considered for complex anal fistula. Another technique, the anal fistula plug, derived from porcine small intestinal submucosa, is safe but modestly effective in long-term follow-up, with success rates varying from 24%-88%. The failure rate may be due to its extrusion from the fistula tract. To obviate that, a new designed plug (GORE BioA®) was introduced, but long term data regarding its efficacy are scant. Fibrin glue showed poor and variable healing rate (14%-74%). FiLaC and video-assisted anal fistula treatment procedures, respectively using laser and electrode energy, are expensive and yet to be thoroughly assessed in clinical practise. Recently, a therapy using autologous adipose-derived stem cells has been described. Their properties of regenerating tissues and suppressing inflammatory response must be better investigated on anal fistulae, and studies remain in progress. The aim of this present article is to review the pertinent literature, describing the advantages and limitations of new sphincter-preserving techniques.
PMCID: PMC4284327  PMID: 25574077
Anal fistula management; Ligation of intersphincteric fistula tract; Plug; Fibrin glue; Fistula laser closure; Video-assisted anal fistula treatment; Adipose-derived stem cells
25.  Repeat Transanal Advancement Flap Repair: Impact on the Overall Healing Rate of High Transsphincteric Fistulas and on Fecal Continence 
Diseases of the Colon and Rectum  2007;50(10):1508-1511.
Transanal advancement flap repair (TAFR) has been advocated as the treatment of choice for transsphincteric fistulas passing through the upper or middle third of the external anal sphincter. It is not clear whether previous attempts at repair adversely affect the outcome of TAFR. The purpose of the present study was to evaluate the success rate of a repeat TAFR and to assess the impact of such a second procedure on the overall healing rate of high transsphincteric fistulas and on fecal continence.
Between January 2001 and January 2005, a consecutive series of 87 patients (62 males; median age, 49 (range, 27–73) years) underwent TAFR. Median follow-up was 15 (range, 2–50) months. Patients in whom the initial operation failed were offered two further treatment options: a second flap repair or a long-term indwelling seton drainage. Twenty-six patients (male:female ratio, 5:2; median age, 51 (range, 31–72) years) preferred a repeat repair. Continence status was evaluated before and after the procedures by using the Rockwood Faecal Incontinence Severity Index (RFISI).
The healing rate after the first TAFR was 67 percent. Of the 29 patients in whom the initial procedure failed, 26 underwent a repeat TAFR. The healing rate after this second procedure was 69 percent, resulting in an overall success rate of 90 percent. Both before and after the first attempt of TAFR, the median RFISI was 7 (range, 0–34). In patients who underwent a second TAFR, the median RFISI before and after this procedure was 9 (range, 0–34) and 8 (range, 0–34), respectively. None of these changes were statistically significant.
Repeat TAFR increases the overall healing rate of high transsphincteric fistulas from 67 percent after one attempt to 90 percent after two attempts without a deteriorating effect on fecal continence.
PMCID: PMC2039788  PMID: 17701070
Transsphincteric fistula; Transanal advancement flap repair; Repeat repair; Fecal incontinence

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