Comparison of clinical outcomes of anal fistula plug and endoanal advancement flap repair treating the complex anal fistula: a systematic review and meta-analysis.

Anal fistula (AF) is a common disease with high prevalence and surgical operations are effective treatments in clinical work. There exist many well-known surgical techniques treating complex anal fistula (CAF), however, none is ideal. To compare the superiority of Anal fistula plug (AFP) and Endoanal advancement flap repair (EAFR) for complex anal fistula. We searched worldwide databases including Pubmed, Embase, Cochrane Library, Web of Science, CNKI, WanFang, VIP, and SinoMed from their inception to March 2023. Studies comparing the outcomes of AFP and EAFR were included according to the PICO principles. The indicators of the healing rate, recurrence rate, wound infection rate, and complication rate, et al. were extracted and compared between different surgical methods. 5 RCTS and 7 non-RCTs were included in the meta-analysis with a total of 847 patients (341 patients conducted with AFP and 506 patients with EAFR). By combining the total effect of the 12 articles, we found that there was a statistical difference reporting the healing rate of AFP 48.3% and EAFR 64.4% treating the CAF (OR 0.68, 95% CI 0.30,1.55, P = 0.03), and EAFR has a better healing rate. However, there was no significant difference in terms of the recurrence rate (OR 1.68, 95% CI 0.80,3.54, P = 0.17), the wound infection rate (OR 1.82, 95% CI 0.95,3.52, P = 0.07), and the complication rate (OR 1.06, 95% CI 0.70,1.61, P = 0.77) either in the 12 articles or in the subgroup. The meta-analysis indicated that the EAFR was superior to AFP in terms of the healing rate treating the CAF, however, there were no significant differences between the two groups when it came to the recurrence rate, the wound infection rate, and the complication rate. EAFR might be one initial treatment for the complex cryptoglandular anal fistulas compared with AFP.

Postoperative three-dimensional endoanal ultrasound findings and relation to anal fistula plug failure.

OBJECTIVES: To explore the utilization of three-dimensional (3D) endoanal ultrasound (EAUS) for the follow-up of the anal fistula plug (AFP), describe morphological findings in postoperative 3D EAUS, and evaluate if postoperative 3D EAUS combined with clinical symptoms can predict AFP failure. MATERIALS AND METHODS: A retrospective analysis of 3D EAUS examinations performed during a single-centre study of prospectively included consecutive patients treated with the AFP between May 2006 and October 2009. Postoperative assessment by clinical examination and 3D EAUS was performed at 2 weeks, 3 months and 6-12 months ("late control"). Long-term follow-up was carried out in 2017. The 3D EAUS examinations were blinded and analysed by two observers using a protocol with defined relevant findings for different follow-up time points. RESULTS: A total of 95 patients with a total of 151 AFP procedures were included. Long-term follow-up was completed in 90 (95%) patients. Inflammation at 3 months, gas in fistula and visible fistula at 3 months and at late control, were statistically significant 3D EAUS findings for AFP failure. The combination of gas in fistula and clinical finding of fluid discharge through the external fistula opening 3 months postoperatively was statistically significant (p < 0.001) for AFP failure with 91% sensitivity and 79% specificity. The positive predictive value was 91%, while the negative predictive value was 79%. CONCLUSIONS: 3D EAUS may be utilized for the follow-up of AFP treatment. Postoperative 3D EAUS at 3 months or later, especially if combined with clinical symptoms, can be used to predict long-term AFP failure.ClinicalTrials.gov identifier NCT03961984.

Surgical management of perianal fistula using an ovine forestomach matrix implant.

PURPOSE: Invasive surgical management of cryptoglandular perianal fistulas (PF) is challenging because of high recurrence rates and the potential for injury to the sphincter complex. In the present technical note, we introduce a minimally invasive treatment for PF using a perianal fistula implant (PAFI) comprising ovine forestomach matrix (OFM). METHODS: This retrospective observational case series highlights 14 patients who had undergone a PAFI procedure at a single center between 2020 and 2023. During the procedure, previously deployed setons were removed and tracts were de-epithelialized with curettage. OFM was rehydrated, rolled, passed through the debrided tract, and secured in place at both openings with absorbable suture. Primary outcome was fistula healing at 8 weeks, and secondary outcomes included recurrence or postoperative adverse events. RESULTS: Fourteen patients underwent PAFI using OFM with a mean follow-up period of 37.6 ± 20.1 weeks. In follow-up, 64% (n = 9/14) had complete healing at 8 weeks and all remained healed, except one at last follow-up visit. Two patients underwent a second PAFI procedure and were healed with no recurrence at the last follow-up visit. Of all patients that healed during the study period (n = 11), the median time to healing was 3.6 (IQR 2.9-6.0) weeks. No postprocedural infections nor adverse events were noted. CONCLUSIONS: The minimally invasive OFM-based PAFI technique for PF treatment was demonstrated to be a safe and feasible option for patients with trans-sphincteric PF of cryptoglandular origin.

Improved fistula plug outcome depends on the type of plug: a single-centre retrospective study.

AIM: Fistula-in-ano is a common condition that is potentially difficult to treat. In recent years 'sphincter-sparing' procedures have increased in popularity due to the lower rates of reported complications, such as incontinence. One such treatment is the fistula plug, which has seen varied success compared with other techniques. There are currently several plugs on the market and it is possible that difference in outcomes could be linked to the type of plug used. The aim of this study was to compare healing and complication rates between two fistula plugs in a single tertiary referral centre in the UK. METHOD: We conducted a single-centre retrospective analysis of all patients over the age of 18 years who underwent elective fistula plug insertion, with two different fistula plugs over a 13-year period. RESULTS: A total of 113 patients underwent fistula plug insertion (plug A n = 90; plug B n = 23). Plug B had been on the market for the final 4 years of the study period, hence the differing patient numbers. There was no difference in patient demographics, fistula type or aetiology of the fistula between the two plugs. Plug B had a significantly higher fistula healing rate compared with plug A (56.5% vs. 12.2%; p < 0.005). A quarter of all patients experienced a complication, 93% being those who had fistula plug A inserted. The most common complication was extrusion of the plug within 72 h of insertion. CONCLUSION: This study demonstrated significantly different outcomes according to the type of fistula plug used. Whilst current randomized controlled trials have not found a significant difference in healing rates when comparing one type of fistula plug to other treatment modalities, this study suggests that plug type may influence efficacy.

Single Institution Outcome of Minimally Invasive Enterocutaneous Fistula Management Utilizing the Biodesign® Fistula Plug.

PURPOSE: To report the outcomes of the Biodesign Fistula Plug as an alternative treatment for enterocutaneous fistulae by presenting our institutional experience from 2013 to 2020. MATERIALS AND METHODS: A retrospective review of all attempted fistula closures utilizing the Biodesign Fistula Plug at a single institution from 2012 to 2020 was performed under IRB approval and in compliance with HIPAA. Patient demographics were obtained including age at the time of the procedure, etiology, location of the fistula, history of malignancy, prior chemotherapy or radiation, and history of prior surgery or other interventions. Patient follow-up was performed through 7/2020 to evaluate for fistula closure, complications, or subsequent treatments. RESULTS: There were 25 patients who underwent 35 Biodesign Fistula Plug placements. Of these, 7 procedures were successful, defined as closure of the fistula, and 28 procedures were unsuccessful, defined as persistent fistula output or requiring further intervention on the EC fistula. There were 7 major complications, SIR classification D = 3, E = 2 and F = 2. No statistically significant risk factors were found predicting fistula plug failure although there was a trend towards patients with malignancy having unsuccessful outcome (p = 0.057). The average number of procedures for patients with successful closure was 1.4 versus 4.22 for those with unsuccessful closure. The average time to plug failure was 27.8 days (range 3-163 days), and the average time to fistula closure following plug placement was 21.4 days (range 14-30). CONCLUSION: Enterocutaneous fistulae are complex and morbid with no good treatment options. These findings demonstrate the Biodesign Fistula Plug can be successful in select patients, however, should be used with great caution due to high rate of failure and complications including two patient deaths.

Minor Sphincter Sparing Surgery for Successful Closure of Perianal Fistulas in Patients with Crohn's Disease.

The purpose of this study is to demonstrate that repetitive minor surgical procedures allow for a high rate of permanent closure of perianal fistulas in patients with Crohn's disease (CD). Patients with perianal fistulizing CD (PFCD) who underwent perianal surgery at the University Hospital of Muenster between 2003 and 2018 were assessed for fistula characteristics and surgical procedures. We included 45 patients (m:f = 28:17) with a mean age of 27 years at first fistula appearance. Of these, 49% suffered from a complex fistula. An average of 4.2 (1-14) procedures were performed, abscess incisions and fistula seton drainages included. Draining setons were left in place for 5 (1-54) months, until fistula closure. Final surgical techniques were fistulotomy (31.1%), seton removal with sustained biological therapy (26.7%), Anal Fistula Plug (AFP) (17.8%), Over-The Scope-Clip proctology (OTSC) (11.1%), and mucosa advancement flap (4.4%). In 8.9% of cases, the seton was kept as permanent therapy. The time from first to last surgery was 18 (0-182) months and the median follow-up time after the last surgery was 90 (15-200) months. The recurrence rate was 15.5% after 45 (17-111) months. Recurrent fistulas healed after another 1.86 (1-2) surgical re-interventions. The final success rate was 80%. Despite biological treatment, PFCD management remains challenging. However, by repeating minor surgical interventions over a prolonged period of time, high permanent healing rates can be achieved.

Treatment of Complex Anal Fistula by Video-Assisted Anal Fistula Treatment Combined with Anal Fistula Plug: A Single-Center Study.

Objective. The surgical treatment of complex anal fistulae is very challenging because of the incidence of incontinence after traditional approaches. There are no studies on the role of video-assisted anal fistula treatment (VAAFT) combined with anal fistula plug (AFP) in the complex anal fistulae. The aim of this study was to demonstrate the efficacy of treating complex anal fistulae using VAAFT combined with AFP. Method. This was a retrospective, nonrandomized observational study. 57 consecutive patients with complex anal fistulae who had undergone the VAAFT with AFP in our hospital between April 2016 and December 2019 were included. The primary outcomes were the cure rate, recurrence rate, and Wexner incontinence scores; the secondary outcomes were surgery time, blood loss, wound healing time postoperatively, pain, and patient satisfaction. Results. All 57 patients completed the surgery and follow-up, with an average follow-up time of 28 months; 6 patients suffered with recurrence (recurrence rate: 10.5%). The average surgery time was 57.9 minutes, and the average wound healing time was 46 days. There were no severe postoperative complications, and anal sphincter function was protected in all patients. Conclusions. The treatment of complex anal fistula by VAAFT combined with AFP is safe and effective, has a high healing rate and few postoperative complications, and is a promising surgery that can effectively protect the patient's anal sphincter function.

Video-assisted anal fistula treatment combined with anal fistula plug for treatment of horseshoe anal fistula.

OBJECTIVE: Horseshoe anal fistula is a common anorectal disease, and there is no standard procedure for its treatment. In this study, we performed a modified surgical procedure for the treatment of horseshoe anal fistula and investigated its efficacy and adverse effects. METHODS: We retrospectively analyzed the outcomes of video-assisted anal fistula treatment combined with an anal fistula plug (VAAFT-Plug) in 26 patients with a horseshoe anal fistula. The follow-up period ranged from 6 to 18 months. Preoperative and postoperative data were collected to analyze the cure rate, anal sphincter function, and incidence of complications. RESULTS: The surgeries were successfully performed in all patients, 23 of whom were cured (effective cure rate of 88.46%). Three patients developed recurrence and were cured after traditional surgery. No patients developed severe complications or postoperative anal incontinence. The VAAFT-Plug protocol was performed with a small incision in the fistula that subsequently promoted fistula healing and preserved sphincter function. CONCLUSION: Although randomized controlled trials will be needed to fully validate these findings, our results suggest that VAAFT-Plug represents a promising treatment strategy for horseshoe anal fistulas. This technique preserves normal anal function and achieves satisfactory outcomes in most patients.

Effects of an anal fistula plug on anal function after surgery for treatment of a trans-sphincteric anal fistula.

PURPOSE: The aim of this study was to evaluate the anal function in patients with trans-sphincteric anal fistulas who underwent an anal fistula plug procedure, and analyze risk factors that might affect post-operative anal function. METHODS: This was an observational, retrospective study of patients diagnosed with trans-sphincteric anal fistulas and initially underwent anal fistula plug procedures between August 2008 and September 2012 at our institute. The analysis includes clinical characteristics, anal fistula healing, and the Wexner score for pre- and post-operative anal function (0 = no incontinence to 20 = complete incontinence). RESULTS: A total of 123 patients who had an adequate follow-up in the end were included. The median duration of follow-up was 8 years (range 72-121 months). The overall healing rate was 56% (69/123), and 33 (26.8%) patients had decreased anal function after surgery. The post-operative Wexner score on anal function was significantly higher than that before the operation (p < 0.001), as well as scores of gas, liquid stool, solid stool incontinence, and alteration in lifestyle (p < 0.05). Based on multiple logistic regression analysis, a high body mass index (p < 0.001) and long distance between the external opening and anal verge (p = 0.003) were significantly associated with a decline in post-operative anal function. CONCLUSIONS: As a sphincter-preserving technique for the treatment of anal fistulas, the anal fistula plug procedure might impair the anal function. Especially for patients with obesity or long distance between the external opening of anal fistula and anal verge, the reduced anal function is more likely to occur after treatment with anal fistula plug therapy.

Long-term outcome of the Surgisis® (Biodesign® ) anal fistula plug for complex cryptoglandular and Crohn's fistulas.

AIM: To evaluate the long-term success rate of treatment with the Surgisis® (Biodesign® ) anal fistula plug for complex anal fistulas, assess fistula plug failure over time and compare success rates for fistula plug between a group of patients with cryptoglandular fistula and another group with Crohn's fistula. METHOD: This is a single-centre study of consecutive patients treated with the Surgisis® (Biodesign® ) anal fistula plug between May 2006 and October 2009. All patients had complex anal fistulas in need of surgical treatment. The patients were assessed preoperatively by physical examination and three-dimensional (3D) endoanal ultrasound, and treated with a loose seton. Postoperative assessment by clinical examination and 3D endoanal ultrasound was performed at 2 weeks, 3 months and 6-12 months. Long-term follow-up was carried out in 2017 using a questionnaire, and clinical examination combined with 3D endoanal ultrasound was performed if the questionnaire indicated any signs of fistula recurrence. RESULTS: A total of 95 patients were included; 30 had quiescent Crohn's disease. Overall, 151 plug procedures were performed. Long-term follow-up was undertaken in 90 (95%) patients; the results showed that after a median period of 110 months, the overall healing rate after one to five plug procedures was 38%. No statistically significant difference in success rate was found between the cryptoglandular fistula group and the Crohn's fistula group (P = 0.37). No further healing was observed after the use of three plugs. CONCLUSION: Considering its low morbidity in a complex disease with high recurrence rates over time, the anal fistula plug may still be considered as one of the first-line treatments for patients with complex anal fistulas.

[Long-term effect of anal fistula plug treatment on postoperative anal function in patients with trans-sphincteric perianal fistula and risk factors associated with anal function].

Objective: To evaluate the long-term effects of anal fistula plug treatment on postoperative anal function in patients with trans-sphincteric perianal fistula, and identify risk factors associated with anal function. Methods: A case-control study was conducted. Clinical and follow-up data of 123 patients with trans-sphincteric perianal fistula receiving anal fistula plug treatment in Beijing Chaoyang Hospital from August 2008 to September 2012 were retrospectively analyzed. The follow-up deadline was April 30, 2020. The Wexner score for incontinence was used to evaluate pre-and postoperative anal function (range from 0 to 20, with higher score representing worse function). The potential risk factors affecting postoperative anal function, including gender, age, fasting blood glucose, diabetes, smoking, alcoholism, location of external opening of anal fistula, surgeon expertise and operation time, were statistically analyzed. Results: Among the 123 patients, 114 were male and 9 were female, the median age was 39 (15-69) years, body mass index (BMI) was (26.2±3.9) kg/m(2), and the median distance between the external opening of anal fistula and the anal verge was 2.6 (1.0-5.0) cm. The median operation time was 30.4 (15.0-60.0) minutes. The median follow-up time was 120 (93-141) months. Sixty-nine patients (56.5%) were healed. The assessment of anal function by Wexner incontinence score showed that 33 (26.8%) patients had anal functional decline after surgery, and the postoperative median Wexner score was 1.34 (0-8), which was significantly higher than preoperative score of 0.17 (0-4) (Z=-5.057, P<0.001). Compared with preoperative levers, postoperative subscores of flatus incontinence, liquid incontinence, solid incontinence and alteration in lifestyle were increased significantly (all P<0.05). Subgroup analysis showed that both in the healed and unhealed groups, the postoperative Wexner scores were higher than those before surgery [healed group: 1.22 (0-8) vs. 0.17 (0-1), Z=-3.796, P<0.001; unhealed group: 1.5 (0-8) vs.0.17 (0-3), Z=-3.422, P=0.001]. Univariate analysis revealed that 33 patients with postoperative anal functional decline had higher BMI, higher fasting blood glucose, higher proportion of alcoholism, longer distance between external opening of anal fistula and the anal verge, and longer operation time (all P<0.05). Multivariate logistic regression analysis testified that higher BMI (OR=1.485, 95% CI: 1.220-1.807, P<0.001) and longer distance between external opening and anal verge (OR=2.207, 95% CI: 1.276-3.220, P=0.003) were independent risk factors for postoperative anal functional decline. Conclusions: The treatment for trans-sphincteric anal fistula with anal fistula plug leads to long-term postoperative anal function decline. For patients with obesity and longer distance between external opening of anal fistula and the anal verge, this procedure should be performed with particular caution, and the anal sphincter should be preserved as much as possible during the operation.

[Long-term efficacy of bioprosthetic anal fistula plug in the treatment of transsphincteric anal fistula].

Objective: To evaluate the long-term healing rate of transsphincteric anal fistula treated with anal fistula plug procedure and the risk factors affecting the healing of anal fistula. Methods: A retrospective case-control study was conducted to analyze the clinical data of 207 patients with transsphincteric anal fistulas who received anal fistula plug procedure at the Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University from August 2008 to September 2012. Inclusion criteria: (1) consistent with the diagnosis of transsphincteric anal fistula: the anal fistula passed through the internal and external sphincter; (2) complete data; (3) initial treatment with anal fistula plug procedure. Exclusion criteria: (1) acute rectal or perianal infection or poorly controlled focal infection; (2) recent incision and drainage of perianal abscess or spontaneous rupture of abscess; (3) patients with malignant tumor; (4) patients with Crohn's disease or ulcerative colitis; (5) patients with heart, liver, brain, lung or renal insufficiency; (6) cachexia due to various chronic wasting diseases; (7) patients could not tolerate surgery. Patients were followed up for anal fistula healing. The cumulative healing rate of patients with transsphincteric anal fistula was plotted using the Kaplan-Meier method, and the factors affecting anal fistula healing were explored by univariate and multivariate logistic regression analysis. Results: There were 186 males and 21 females with age of 15 to 69 (mean 38) years. The duration of anal fistula was 3-60 (mean 15) months. Three patients had a history of previous episodes of perianal abscess and underwent incision and drainage of perianal abscess (all more than 3 months). During follow-up ending on October 31, 2018, 72 patients (34.8%) were lost to follow-up. Among 135 patients who were successfully followed up, the average follow-up period was 96 (75-124) months. Seventy-five patients had anal fistula healing, with healing rate of 55.6%. Kaplan-Meier survival curve showed that the healing time of anal fistula was prolonged and finally stabilized at 55.6%. In the patients who failed initial treatment with anal fistula plug packing, there were 6 cases whose anal fistula healed spontaneously without other treatment. Among them, 3 cases healed spontaneously 2 years and 3 cases 3 years after operation without recurrence. From 2008 to 2012, the annual healing rates of anal fistula plug treatment were 3/6, 61.5% (24/39), 42.1% (24/57), 12/15 and 12/18, respectively. Multivariate logistic regression analysis showed that the duration of anal fistula≥6 months (OR=3.187, 95% CI: 1.361-7.466, P=0.008) was an independent risk factor for anal fistula healing after treatment with anal fistula plug. Conclusion: The long-term efficacy of anal fistula plug procedure in the treatment of transsphincteric anal fistula is positive, and this procedure should be implemented as soon as possible.

Long-term efficacy of bioprosthetic anal fistula plug in the treatment of transsphincteric anal fistula / 中华胃肠外科杂志

Objective@#To evaluate the long-term healing rate of transsphincteric anal fistula treated with anal fistula plug procedure and the risk factors affecting the healing of anal fistula.@*Methods@#A retrospective case-control study was conducted to analyze the clinical data of 207 patients with transsphincteric anal fistulas who received anal fistula plug procedure at the Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University from August 2008 to September 2012. Inclusion criteria: (1) consistent with the diagnosis of transsphincteric anal fistula: the anal fistula passed through the internal and external sphincter; (2) complete data; (3) initial treatment with anal fistula plug procedure. Exclusion criteria: (1) acute rectal or perianal infection or poorly controlled focal infection; (2) recent incision and drainage of perianal abscess or spontaneous rupture of abscess; (3) patients with malignant tumor; (4) patients with Crohn′s disease or ulcerative colitis; (5) patients with heart, liver, brain, lung or renal insufficiency; (6) cachexia due to various chronic wasting diseases; (7) patients could not tolerate surgery. Patients were followed up for anal fistula healing. The cumulative healing rate of patients with transsphincteric anal fistula was plotted using the Kaplan-Meier method, and the factors affecting anal fistula healing were explored by univariate and multivariate logistic regression analysis.@*Results@#There were 186 males and 21 females with age of 15 to 69 (mean 38) years. The duration of anal fistula was 3-60 (mean 15) months. Three patients had a history of previous episodes of perianal abscess and underwent incision and drainage of perianal abscess (all more than 3 months). During follow-up ending on October 31, 2018, 72 patients (34.8%) were lost to follow-up. Among 135 patients who were successfully followed up, the average follow-up period was 96 (75-124) months. Seventy-five patients had anal fistula healing, with healing rate of 55.6%. Kaplan-Meier survival curve showed that the healing time of anal fistula was prolonged and finally stabilized at 55.6%. In the patients who failed initial treatment with anal fistula plug packing, there were 6 cases whose anal fistula healed spontaneously without other treatment. Among them, 3 cases healed spontaneously 2 years and 3 cases 3 years after operation without recurrence. From 2008 to 2012, the annual healing rates of anal fistula plug treatment were 3/6, 61.5% (24/39), 42.1% (24/57), 12/15 and 12/18, respectively. Multivariate logistic regression analysis showed that the duration of anal fistula≥6 months (OR=3.187, 95% CI: 1.361-7.466, P=0.008) was an independent risk factor for anal fistula healing after treatment with anal fistula plug.@*Conclusion@#The long-term efficacy of anal fistula plug procedure in the treatment of transsphincteric anal fistula is positive, and this procedure should be implemented as soon as possible.

Anal fistula plug versus surgeon's preference for surgery for trans-sphincteric anal fistula: the FIAT RCT.

BACKGROUND: The aim of fistula surgery is to eradicate the disease while preserving anal sphincter function. The efficacy of the Surgisis® anal fistula plug (Cook Medical, Bloomington, IN, USA) in the treatment of trans-sphincteric fistula-in-ano has been variably reported. OBJECTIVES: To undertake a randomised comparison of the safety and efficacy of the Surgisis anal fistula plug in comparison with surgeon's preference for the treatment of trans-sphincteric anal fistulas. DESIGN: A randomised, unblinded, parallel-arm, prospective, multicentre clinical trial. SETTING: Hospitals in the UK NHS involving colorectal surgeons accredited by the Association of Coloproctology of Great Britain and Ireland. PARTICIPANTS: Adult patients suffering from trans-sphincteric fistula-in-ano of cryptoglandular origin. INTERVENTIONS: Patients were randomised on a 1 : 1 basis to either the fistula plug or the surgeon's preference [e.g. fistulotomy, cutting seton, advancement flap or ligation of intersphincteric fistula tract (LIFT) procedure]. MAIN OUTCOME MEASURES: The primary outcome measure was quality of life as measured by the Faecal Incontinence Quality of Life (FIQoL) questionnaire at 12-month follow-up. Secondary outcome measures included clinical and radiological fistula healing rates, faecal incontinence rates, complications rates, reintervention rates and cost-effectiveness. RESULTS: Between May 2011 and March 2016, 304 participants were recruited (152 fistula plug vs. 152 surgeon's preference). No difference in FIQoL score between the two trial groups was seen at the 6-week, 6-month or 12-month follow-up. Clinical evidence of fistula healing was reported in 66 of 122 (54%) participants in the fistula plug group and in 66 of 119 (55%) participants in the surgeon's preference group at 12 months. Magnetic resonance imaging (MRI) showed fistula healing in 54 of 110 (49%) participants in the fistula plug group and in 63 of 112 (56%) participants in the surgeon's preference group. Variation in 12-month clinical healing rates was observed: 55%, 64%, 75%, 53% and 42% for fistula plug, cutting seton, fistulotomy, advancement flap and LIFT procedure, respectively. Faecal incontinence rates were low at baseline, with small improvement in both groups post treatment. Complications and reinterventions were frequent. The mean total costs were £2738 [standard deviation (SD) £1151] in the fistula plug group and £2308 (SD £1228) in the surgeon's preference group. The average total quality-adjusted life-years (QALYs) gain was much smaller in the fistula plug group (0.829, SD 0.174) than in the surgeon's preference group (0.790, SD 0.212). Using multiple imputation and probabilistic sensitivity analysis, and adjusting for differences in baseline EuroQol-5 Dimensions, three-level version utility, there was a 35-45% chance that the fistula plug was as cost-effective as surgeon's preference over a range of thresholds of willingness to pay for a single QALY of £20,000-30,000. LIMITATIONS: Limitations include a smaller sample size than originally calculated, a lack of blinding that perhaps biased patient-reported outcomes and a lower compliance rate with MRI at 12-month follow-up. CONCLUSIONS: The Surgisis anal fistula plug is associated with similar FIQoL score to surgeon's preference at 12-month follow-up. The higher costs and highly uncertain and small gains in QALYs associated with the fistula plug mean that this technology is unlikely to be considered a cost-effective use of resources in the UK NHS. FUTURE WORK: Further in-depth analysis should consider the clinical and MRI characteristics of fistula-in-ano in an attempt to identify predictors of fistula response to treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78352529. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 21. See the NIHR Journals Library website for further project information.

Fistula-in-ano is a common condition in which the inside of the anus is in communication with the outside skin. It is a cause of long-term suffering owing to recurrent infection. Many surgical operations have been proposed to treat fistula-in-ano, with varying degrees of success. These carry the risk of faecal incontinence. The aim of the Fistula-In-Ano Trial (FIAT) was to assess the benefits of a new technology, the Surgisis^® anal fistula plug (Cook Medical, Bloomington, IN, USA), compared with other surgical techniques. The FIAT involved 304 participants; 152 participants were treated with the fistula plug and 152 participants were treated with an alternative surgical technique. There were no differences in quality of life (QoL) among participants treated with the fistula plug compared with those receiving other treatments when assessed 12 months following the operation. Successful fistula healing was achieved in 54% of fistula plug-treated participants and in 55% of participants treated with an alternative technique at 12 months following the operation. Few patients suffered from faecal incontinence before their operation and there was a slight improvement following treatment with the fistula plug and other surgical treatments. The only difference seen between the group treated with the fistula plug and those receiving other surgical treatments was in the complication rate at the 6-week assessment time, with the fistula plug group having higher rates of unexpected pain. Economic analysis of the fistula plug compared with the other surgical treatments showed that the fistula plug was more expensive and only produced very small improvements in QoL. On this basis, it is unlikely that decision-makers in the NHS will support the routine use of the fistula plug.

Anal fistula plug vs rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a systematic review and meta-analysis of studies with long-term follow-up.

AIM: The aim was to compare the effectiveness of the anal fistula plug (AFP) with the rectal advancement flap (RAF) for complex cryptoglandular anal fistulas. METHODS: We conducted a literature search to identify relevant available articles published without language restriction from Embase and PubMed databases and the Cochrane Library. Studies comparing outcomes with the AFP vs RAF for complex cryptoglandular anal fistulas were eligible for inclusion. RESULTS: A total of 11 articles with 810 patients were included in this meta-analysis. Four RCTs and one observational clinical study provided long-term follow-up. The pooled analysis of all 11 studies indicated that there was no significant difference between the AFP and RAF in terms of healing rate, recurrence rate and incidence of fistula complications. However, the pooled results of studies with long-term follow-up revealed that the RAF group had a significantly higher healing rate (OR 0.32, 95% CI 0.13, 0.78, P = 0.01) and lower recurrence rate (OR 4.45, 95% CI 1.45, 13.65, P = 0.009) than the AFP group. CONCLUSIONS: For the treatment of complex cryptoglandular anal fistulas, the RAF was superior to the AFP in terms of healing and recurrence rate after pooling of randomized controlled trials with long-term follow-up, even though a comparison based on the pooling of all studies showed no significant difference.

Long-term outcomes of (Gore) fistula plug versus ligation of intersphincteric fistula tract for anal fistula / Desfechos de longo prazo do tampão de fístula (Gore) versus ligadura do trato da fístula interesfincteriana (LIFT) para fístula anal

ABSTRACT Background: The surgical treatment of anal fistula is complex due to the possibility of fecal incontinence. Fistulotomy and cutting Setons have the same incidence of fecal incontinence depending on the complexity of the fistula. Sphincter-preserving procedures such as anal fistula plug and ligation of intersphincteric fistula tract procedure may result in more recurrence requiring repeated operations. The aim of this study was to evaluate and compare the outcomes of treating fistula in Ano utilizing two methods: Fistula plug (Gore Bio-A) and ligation of intersphincteric tract (LIFT). Methods: Fifty four patients (33 males; 21 female, median ages 42 [range 32-47] years) with high anal inter-transphenteric fistula were treated with LIFT and fistula plug procedures from September 2011 until August 2016 by a single surgeon and were retrospectively evaluated. All were followed for a median of 23.9 (range 4-54) months with clinical examination. Twenty one patients underwent fistula plug and 33 patients underwent LIFT procedure (4 patients of the LIFT group underwent LIFT and rectal mucosa advancement flap). The healing rate and complications were evaluated clinically and through telephone calls. Results: The mean operative time for the Plug was 25 ± 17 min and for the LIFT was 40 ± 20 min (p = 0.017) and the mean hospital stay was 2.4 ± 1.1 and 1.9 ± 0.3 (p = 0.01) respectively. The early complications of the plug and LIFT procedures included; anal pain (33.3%, 66.6%, p = 0.13), perianal discharge (77.8%, 91%, p = 0.62), anal pruritus (38.9%, 50.0%, p = 0.71) and bleeding per rectum (16.7%, 33.3%, p = 0.39) respectively. The overall mean follow-up was 20.9 ± 16.8 months, p = 0.68. There was no statistically significant difference between the two groups (21.9 ± 7.5 months, 19.9 ± 16.1 months, p = 0.682). The healing rate was 76.2% (16/21 patients) in the fistula plug group and 81.1% (27/33 patients) in the LIFT group (p = 0.73). Patients who had LIFT procedure and a mucosal advancement flap had 100% healing rate (4 out of 4 patients). No incontinence of stool or feces and no fistula plug expulsion were seen in our patients. The healing time ranged from 1 to 6 months after surgery. There was no post-operative perianal abscess, cellulitis or pain. Conclusions: LIFT and anal plug are safe procedures for patients with primary and recurrent anal fistula. Both techniques showed excellent results in terms of healing and complication rate. None of our patients had incontinence after 5 years follow-up. The best success rate in our patients was seen after LIFT procedure with mucosal advancement flap. Larger and controlled randomized trials are needed for better assessment of treatment options.

RESUMO Introdução: O tratamento cirúrgico da fístula anal é complexo devido à possibilidade de incontinência fecal. A fistulotomia e o seton de corte têm a mesma incidência da incontinência fecal, dependendo da complexidade da fístula. Procedimentos de preservação do esfíncter, como o tampão da fístula anal e o procedimento LIFT (ligadura do trato da fístula interesfincteriana), podem resultar em mais recorrência, exigindo cirurgias repetidas. O objetivo deste estudo foi avaliar e comparar os desfechos do tratamento da fístula anal utilizando dois métodos: Tampão de fístula (Gore Bio-A) e Ligadura do Trato Interesfincteriano (LIFT). Métodos: Cinquenta e quatro pacientes (33 homens; 21 mulheres, com mediana de idade de 42 [variação 32-47] anos) foram tratados com LIFT e procedimentos com tampão de fístula de setembro de 2011 até agosto de 2016 por um único cirurgião e foram avaliados retrospectivamente. Todos foram acompanhados por uma mediana de 23,9 (variação de 4 a 54) meses com exame clínico. Vinte e um pacientes foram submetidos a tampão de fístula e 33 pacientes foram submetidos ao procedimento LIFT (4 pacientes do grupo LIFT foram submetidos a LIFT e retalho de avanço da mucosa retal). A taxa de cicatrização e as complicações foram avaliadas clinicamente e por meio de ligações telefônicas. Resultados: O tempo cirúrgico médio para o Tampão foi de 25 ± 17 minutos e para o LIFT foi de 40 ± 20 minutos (p = 0,017) e o tempo médio de internação foi de 2,4 ± 1,1 e 1,9 ± 0,3 (p = 0,01), respectivamente. As primeiras complicações dos procedimentos de tampão e LIFT incluíram: dor anal (33,3%, 66,6%, p = 0,13), secreção perianal (77,8%, 91%, p = 0,62), prurido anal (38,9%, 50,0%, p = 0,71) e sangramento pelo reto (16,7%, 33,3 %, p = 0,39) respectivamente. A média geral de acompanhamento foi de 20,9 ± 16,8 meses, p = 0,68. Não houve diferença estatisticamente significativa entre os dois grupos (21,9 ± 7,5 meses, 19,9 ± 16,1 meses, p = 0,682). A taxa de cicatrização foi de 76,2% (16/21 pacientes) no grupo com tampão de fístula e 81,1% (27/33 pacientes) no grupo LIFT (p = 0,73). Pacientes submetidos ao procedimento LIFT e um retalho de avanço da mucosa tiveram 100% de taxa de cura (4 de 4 pacientes). Nenhuma incontinência fecal e nenhuma expulsão do tampão da fístula foram observadas em nossos pacientes. O tempo de cicatrização variou de 1 a 6 meses após a cirurgia. Não houve abscesso perianal, celulite ou dor no pós-operatório. Conclusões: LIFT e tampão anal são procedimentos seguros para pacientes com fístula anal primária e recorrente. Ambas as técnicas apresentaram excelentes resultados em termos de cicatrização e taxa de complicações. Nenhum de nossos pacientes teve incontinência após 5 anos de acompanhamento. A melhor taxa de sucesso em nossos pacientes foi observada após o procedimento LIFT com retalho de avanço da mucosa. Ensaios clínicos randomizados de maior porte e controlados são necessários para melhor avaliação das opções de tratamento.

Extracellular matrix fistula plug for repair of bronchopleural fistula.

INTRODUCTION: Bronchopleural fistula (BPF) is a feared complication of pulmonary resection. Fistula plugs (FP) have been described as an adequate treatment in anorectal disease. We describe our early experience placing an FP in the treatment of BPF. MATERIALS AND METHODS: We retrospectively reviewed 5 patients for whom a FP was placed for BPF at our institution. Demographic data, initial perioperative information, method and technique of FP placement, and success is reported. RESULTS: Five patients (4 male, 1 female) with a median age of 63 years (range, 57-76 years) underwent 6 FP placements for BPF. Two patients were post-pneumonectomy and 3 patients post-lobectomy. The median time to presentation following surgery was 118 days (range 22-218). Upon bronchoscopic or operative re-evaluation, 3 patients had successful cessation of their air leak at 0, 1 and 4 days. Two of three patients subsequently underwent a thoracic muscle flap placement to augment healing. One patient had a persistent air leak despite 2 separate FP placements. The air leak stopped with endobronchial valves (EBV) which were deployed proximal to the FP, 9 days after placement of the FP. Another patient had a successful muscle flap placed 80 days after FP placement. There were no complications associated with the FP. Three of five patients were deemed successfully treated with FP placement alone. CONCLUSION: In patients with a postoperative BPF and pleural window, placement of a FP had a modest success rate and can be considered as a treatment modality option for BPF.

Treatment of fistula in-ano with fistula plug: experience of a tertiary care centre in South Asia and comparison of results with the West.

OBJECTIVES: Surgery for fistula in ano is associated with anal incontinence. The biologic anal fistula plug (AFP) can minimize this. This is a retrospective analysis of patients with cryptoglandular anorectal fistulae, who underwent a surgical procedure using AFP. Patient's demographics and characteristics of the fistulae were obtained from a prospective database. Each primary opening was occluded by using an AFP. Success was defined by the closure of the external opening and absent drainage. RESULTS: Fifty-one patients were treated with AFP (male:female: 37:14), mean age 42 years (SD ± 14.86, range 26-70). Ten patients defaulted follow-up. Forty-seven procedures were analysed. Twenty-three (56.1%) patients had complete healing while 18 (43.9%) patients failed the fistula plug procedure during the follow up period of 12 months. Logistical regression failed to identify any statistical significant association with demographic or disease factors and healing. Healing was 1.5 times less likely for every failed procedure prior to AFP insertion. Contrary to other published studies, placement of fistula plug was associated with much lower overall rates of fistula healing. Highest success rates were seen in simple fistulae when compared to the complex type. Repeat plug placement may be successful in selected patients.

Comparison of an anal fistula plug and mucosa advancement flap for complex anal fistulas: a meta-analysis.

OBJECTIVE: The aim of this analysis was to compare the advantages of the anal fistula plug (AFP) with the mucosa advancement flap (MAF) for complex anal fistulas. METHODS: Comparative studies of the efficacy of AFP and MAF were included. Two independent reviewers selected articles for inclusion. After information collection, a meta-analysis was performed using data on overall healing rates, complications, incontinences and recurrences. The quality of postoperative life and cost were also included with the clinical results. RESULTS: Ten studies included 778 patients who were divided into AFP and MAF groups in this meta-analysis. During the follow-up period, no significant difference in healing rates, complications and recurrences were found (P = 0.55, P = 0.78 and P = 0.23, respectively). The incontinence rate of AFP was lower than that of MAF (P = 0.04). The postoperative quality of life of AFP patients was superior to that of MAF patients. The AFP patients had less persistent pain of a shorter duration and shortened healing time and hospital stay. The treatment cost of AFP patient was lower than that of MAF. CONCLUSION: Compared to the MAF procedure, the AFP procedure has some advantages for complex anal fistulas, but more and large randomized clinical trials comparing the two procedures for fistula management need to be conducted.

Prospective evaluation of a new device for the treatment of anal fistulas.

AIM: To evaluate the safety of the implantation of a new device for the treatment of anal fistulas. The short-term clinical efficacy was also assessed. METHODS: This study took place at a tertiary care university hospital. Patients with a complex anal fistula of cryptoglandular origin were enrolled in the study and were treated with insertion of the new device. All patients were evaluated by clinical and physical examination, including an endoanal ultrasound at the baseline, and then at the 2 wk and 1, 2, 3 and 6-mo follow-up visits. RESULTS: Morbidity, continence status, and success rate were the main outcome measures. Ten patients underwent the placement of the new device. The fistulas were transphincteric in eight patients and extrasphincteric in the remaining two. The median duration of the surgical procedure was 34.5 (range, 27-42) min. Neither intra- nor postoperative complications occurred, and all patients were discharged the day after the procedure. At the 6-mo follow-up evaluation, the final success rate was 70%. Three failures were registered: a device expulsion (on the 10(th) postoperative day), the persistence of inflammatory tissue around the fistula tract (at the 2-mo follow up), and the persistence of serum discharge (at the 6-mo follow up). No patient experienced any change incontinence, as assessed by the Cleveland Clinic Fecal Incontinence score. CONCLUSION: The technical procedure is simple and has low risk of perioperative morbidity. The pre- and post-operative continence status did not change in any of the patients. The initial results at the 6-mo follow up seem to be promising. However, a longer follow-up period and a larger sample size are needed to confirm these preliminary results.