Collagen treatment of complex anorectal fistula: 3 years follow-up.

Fistula in ano is a common anorectal disease in adults. Currently, surgery remains the definitive therapeutic approach, but in some cases, it can lead to serious complications as faecal or gas incontinence. Therefore, sphincter sparing treatments should be considered for complex fistulas. One of the sphincteric preserving treatment is the filling with a dermal extract commonly called "collagen glue" as Salvecoll-E® gel. This is a multicentric, prospective, observational study on the use of Salvecoll-E® gel in treatment of complex anal fistulas. We treated 70 patients from May 2016 to May 2017. In the first phase, we debrided the fistula tract using a loose seton kept for 4-6 weeks. In the second phase, the seton was removed and the fistula tract was filled with Salvecoll-E® gel. In this article, we report results at 36 months of follow-up. Fifty patients (71.4%) had completely healed fistula within 36 months of follow-up. Twenty-eight patients (28.2%) had recurrences. Among these failures, 65% were within 6 months. All low transphincteric fistulas healed. Recurrences occurred only in median and high transphincteric fistulas. No patient had a worsening of continence status measured with Cleveland Clinic Florida Incontinence Severity score. Salvecoll-E® gel is a recent finding among sphincter-sparing treatments. In this study, we demonstrate that it is a safe option in the treatment of complex fistulas. Final results are satisfactory and in line with the best results published in literature among mini-invasive treatments.

Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration.

INTRODUCTION: The goal of this project was to create an up-to-date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI. METHODS: These guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher-level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus. RESULTS: These guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients. CONCLUSION: These multidisciplinary European guidelines provide an up-to-date comprehensive evidence-based framework with recommendations on the diagnosis and management of adult patients who suffer from FI.

Guideline for the diagnosis and treatment of faecal incontinence: a UEG/ESCP/ESNM/ESPCG collaboration [Pré-print]

The goal of this project was to create an up-to-date joint European clinical practice guideline for the diagnosis and treatment of faecal incontinence (FI), using the best available evidence. These guidelines are intended to help guide all medical professionals treating adult patients with FI (e.g., general practitioners, surgeons, gastroenterologists, other healthcare workers) and any patients who are interested in information regarding the diagnosis and management of FI. These guidelines have been created in cooperation with members from the United European Gastroenterology (UEG), European Society of Coloproctology (ESCP), European Society of Neurogastroenterology and Motility (ESNM) and the European Society for Primary Care Gastroenterology (ESPCG). These members made up the guideline development group (GDG). Additionally, a patient advisory board (PAB) was created to reflect and comment on the draft guidelines from a patient perspective. Relevant review questions were established by the GDG along with a set of outcomes most important for decision making. A systematic literature search was performed using these review questions and outcomes as a framework. For each predefined review question, the study or studies with the highest level of study design were included. If evidence of a higher-level study design was available, no lower level of evidence was sought or included. Data from the studies were extracted by two reviewers for each predefined important outcome within each review question. Where possible, forest plots were created. After summarising the results for each review question, a systematic quality assessment using the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach was performed. For each review question, we assessed the quality of evidence for every predetermined important outcome. After evidence review and quality assessment were completed, recommendations could be formulated. The wording used for each recommendation was dependent on the level of quality of evidence. Lower levels of evidence resulted in weaker recommendations and higher levels of evidence resulted in stronger recommendations. Recommendations were discussed within the GDG to reach consensus. These guidelines contain 45 recommendations on the classification, diagnosis and management of FI in adult patients. These multidisciplinary European guidelines provide an up-to-date comprehensive evidence-based framework with recommendations on the diagnosis and management of adult patients who suffer from FI.

Deadlock of proctologic practice in Italy during COVID-19 pandemic: a national report from ProctoLock2020.

Proctology is one of the surgical specialties that suffered the most during COVID-19 pandemic. Using data from a cross-sectional worldwide web survey, we aimed to snapshot the current status of proctologic practice in Italy with differences between three macro areas (North, Centre, South). Specialists affiliated to renowned scientific societies with an interest in coloproctology were invited to join a 27-item survey. Predictive power of respondents' and hospitals' demographics on the change of status of surgical activities was calculated. The study was registered at ClinicalTrials.gov (NCT04392245). Of 299 respondents from Italy, 94 (40%) practiced in the North, 60 (25%) in the Centrer and 82 (35%) in the South and Islands. The majority were men (79%), at consultant level (70%), with a mean age of 46.5 years, practicing in academic hospitals (39%), where a dedicated proctologist was readily available (68%). Southern respondents were more at risk of infection compared to those from the Center (OR, 3.30; 95%CI 1.46; 7.47, P = 0.004), as were males (OR, 2.64; 95%CI 1.09; 6.37, P = 0.031) and those who routinely tested patients prior to surgery (OR, 3.02; 95%CI 1.39; 6.53, P = 0.005). The likelihood of ongoing surgical practice was higher in the South (OR 1.36, 95%CI 0.75; 2.46, P = 0.304) and in centers that were not fully dedicated to COVID-19 care (OR 4.00, 95%CI 1.88; 8.50, P < 0.001). The results of this survey highlight important factors contributing to the deadlock of proctologic practice in Italy and may inform the development of future management strategies.

From high volume to "zero" proctology: Italian experience in the COVID era.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic hit Italy early and strongly, challenging the whole health care system. Proctological patients and surgeons are experiencing a previously unseen change in care with unknown repercussion. Here we discuss the proctological experience of 4 Italian hospitals during the COVID-19 pandemic. METHODS: Following remote brainstorming, the authors summarised their experience in managing proctological patients during the COVID-19 pandemics and put forward some practical observations to further investigate. RESULTS: The 4 hospitals shifted from a high-volume proctological activity to almost "zero" visits and surgery. Every patient accessing the hospital must respect a specific COVID-19 protocol. Proctological patients can be stratified based on presentation and management considerations into (1) neoplastic patients, the only allowed to be surgically treated, (2) the ones requiring urgent care, operated only in highly selected cases and (3) the stable, already known patients, managed remotely. Changes in the clinical management of the proctological disease are presented together with some considerations to be explored. CONCLUSIONS: In the absence of scientific evidence, these practical considerations may be valuable to proctological surgeons starting to face the COVID-19 pandemics. Beside the more clinical considerations, this crisis produced unexpected consequences such as an improvement of the therapeutic alliance and a shift towards telemedicine that may be worth exploring also in the post-COVID-19 era.

Radiofrequency hemorrhoidectomy: less is less? Results of a comparative study.

BACKGROUND: Radiofrequency has been introduced as an instrument conceived to upgrade the conventional treatment of hemorrhoidectomy. To reduce the economic aspect, recently a new radiofrequency device has been introduced: Vojant™. The aim of this study was to compare the clinical outcomes of hemorrhoidectomy with LigaSure™ and Vojant™, performed with the Milligan-Morgan technique, on the medium term. METHODS: Between January 2016 and December 2016, 50 consecutive patients with symptomatic grade III and IV were scheduled for surgical treatment. Patients were assigned randomly to either Vojant™ or LigaSure™ hemorrhoidectomy. All preoperative and postoperative data were collected. RESULTS: Patients in the LigaSure™ group experienced less pain than those treated with Vojant™, (P<0.05). In the Vojant™ group one patient developed immediate postoperative bleeding (within 48 hours), the other one seven days after surgery. Complete wound healing and return to work activities was faster in the LigaSure™ group (P<0.05). One case of stenosis in the LigaSure™ group and two in the Vojant™ group were detected (P>0.05). CONCLUSIONS: Radiofrequency hemorrhoidectomy with Vojant™ seems a valid alternative to LigaSure hemorrhoidectomy.

Surgical Treatment of Rectovaginal Fistula in Crohn's Disease: A Tertiary Center Experience.

BACKGROUND: Rectovaginal fistula (RVF) is a disastrous complication of Crohn's disease (CD) that is exceedingly difficult to treat. It is a disabling condition that negatively impacts a woman's quality of life. Current treatment algorithms range from observation to medical management to the need for surgical intervention. A wide variety of success rates have been reported for all management options. The choice of surgical repair methods depends on various fistula and patient characteristics, and its published success rates vary with initial success being around 50% rising to 80% with repeated surgery. Several surgical and sphincter sparing approaches have been described for the management of rectovaginal fistula, aimed to minimize the recurrence and to preserve the continence. MATERIALS AND METHODS: A retrospective study was performed for RVF repair between 2008 and 2014 in our tertiary centre at the University Hospital of Tor Vergata, Italy. All the patients were affected by Crohn's disease and underwent surgery for an RVF under the same senior surgeon. All patients were prospectively evaluated. RESULTS: All 43 patients that underwent surgery for RVF were affected by Crohn's disease. The median age was 43 years (range 21-53). Four different surgical approaches were performed: drainage and seton, rectal advacenment flap (RAF), vaginal advancement flap (VAF), transperineal approach using porcine dermal matrix (PDM), and martius flap (MF). The median time to success was six months (range 2-11). None of the patients were lost during the 18 months of follow-up. The failure group rate was 19% in contrast with the healing rate group that was 81%. No demographic of disease-related factors were found to influence healing. CONCLUSION: The case series of this study supports the dogma that "there are no absolute rules when treating Crohn's fistula". There is no gold standard technique; however, it is mandatory to minimize the recurrence with a sphincter saving technique. Randomized trials are needed to find a standard surgical approach.

Endoluminal Vacuum Therapy as Treatment for Anastomotic Colorectal Leakage.

BACKGROUND: The clinical leakage rate after anterior resection varies from 2.8-20%, with a 6-22% mortality rate and a 10-80% risk of permanent stoma. Endo-SPONGE® (B. Braun Melsungen AG, Melsungen, Germany) may treat extraperitoneal anastomotic leakage in the lesser pelvis. It consists of an open-pored sponge inserted into the cavity. A drainage tube fixed to a low vacuum drainage system is then connected to the sponge through the anus. MATERIAL AND METHODS: Between January 2007 and December 2014, 14 patients with anastomotic leakage following low anterior resection were treated with Endo-SPONGE® and were prospectively evaluated. In all patients, a CT-scan was performed and they received an intravenous antibiotic therapy with piperacillin+tazobactam (4.5g,3 times/daily). Complete healing was defined as endoscopically proven closure of the insufficiency cavity with a normal mucosa. RESULTS: Stapled straight end to end, colorectal anastomoses were performed in all patients between 3-7 cm above the anal verge, a protective loop ileostomy was performed in every patient. The diagnosis of anastomotic leakage was performed after a median interval of 14 days, the median size of the cavity was 81x46 mm. Fluid collection was drained, percutaneosly in 12 cases, surgically in two patients. The median duration of therapy was 35 days, with 3-14 sponge exchanges for each patient. Median healing time was 37 days. No intraoperative complications were recorded, however, we found five cases of mild anal pain treated medically. CONCLUSION: Considering the literature and our results, the Endo-SPONGE® seems an effective, minimally invasive procedure to treat extraperitoneal anastomotic leakage, reducing morbidity, mortality, and hospital stay.

May radiofrequency be the best choice for III-IV degree hemorrhoids?

BACKGROUND: Hemorrhoidectomy is considered the most efficient method to treat hemorrhoids of III and IV grades. The aim of this study was to compare conventional diathermy hemorrhoidectomy and radiofrequency hemorrhoidectomy based on a large series of patients. METHODS: Between June 2001 and June 2014, 1000 patients have been treated with radiofrequency hemorrhoidectomy (group A) and 500 patients have been treated with diathermy (group B) as a day-case procedure. Operating time, postoperative pain score, hospital stay, early and late postoperative complications, wound healing time and time to return to normal activities were assessed. RESULTS: The mean follow-up was seven years. The mean operating time for radiofrequency hemorrhoidectomy was shorter than diathermy but not significantly. Patients treated with radiofrequency had significantly less postoperative pain (measured on a Visual Analogue Scale; P=0.001), a shorter wound healing time, less time off work and postoperative complications (P=0.001) than patients who had diathermy. Neither wound healing nor mean hospital stay (day-case surgery) was significantly different. CONCLUSIONS: Radiofrequency hemorrhoidectomyis a valid alternative to the conventional diathermy technique, due to the reduction of operative time, postoperative pain, early and late complication rate.

LigasureTM hemorrhoidectomy: how we do.

BACKGROUND: Hemorrhoidectomy is considered the gold standard and the most effective and definitive treatment for grades 3 or 4 hemorrhoids, and Milligan-Morgan's and Ferguson's procedures are the most widely used techniques throughout the world. The aim of the study was to present our surgical technique using LigasureTM vessel sealing, focus on technical aspects and surgical tricks showing our results with a huge number of patients and a long-term follow-up. METHODS: Between June 2001 and June 2014 at the University Hospital of Tor Vergata, Rome, Italy, 1000 patients were selected to underwent LigasureTM hemorrhoidectomy for III and IV degree hemorrhoids. Age range 19-80 years, ASA I-II-III. Operating time, postoperative pain score, hospital stay, early and late postoperative complications, wound healing time and time to return to normal activities were assessed. Patients were followed-up at one week, one month, six, and twelve months after the operation and after 60 months they responded to the follow-up telephone interview and replied to the questionnaire. RESULTS: One-thousand patients were undergone LigasureTM hemorrhoidectomy. The mean follow-up was 7 years and 110 (11%) patients was lost from the follow-up after the first postoperative month. Among early postoperative complications, 21 patients (2.1%) has urinary retention treated with a urinary catheter and removed before the discharge. 3 (0.3%) patients had a minor bleeding that required a package of hemostatic absorbable sponge, as late complications, in 35 patients (4%) anal fissure due to hard stool, an incomplete healing was observed in 11 patients (1.1%) after the first month. Three transphincteric anal fistulas (0.3%) were collected and four perianal abscess (0.4%) were observed during the first month of the follow-up and they required a delayed surgical treatment. At the end of the seven years of follow-up 70 recurrences (7.8%) and 35 anal stenosis (4%) were detected. CONCLUSIONS: If technical guidelines are respected rigorously and the device is applied correctly, feared late complications, such as impaired fecal continence, anal stricture and postoperative pain can be minimized.

Does a relationship still exist between gastroesophageal reflux and Helicobacter pylori in patients with reflux symptoms?

BACKGROUND: The nature of the relationship between Helicobacter pylori and reflux esophagitis (RE) is not fully understood. In addition, the effect of H. pylori eradication on RE and gastroesophageal reflux disease (GERD) is unclear. This study was designed to investigate the relationship between H. pylori infection and the grade of GERD in patients with reflux symptoms. METHODS: Between January 2010 and July 2013, 184 consecutive patients with daily reflux symptoms for at least one year were evaluated at the ambulatory for functional esophageal disease, Tor Vergata University Hospital, Rome, Italy. All patients underwent a pretreatment evaluation, which included anamnesis, clinical examination, Esophagogastroduodenoscopy (EGDS) with biopsy, esophageal manometry and 24-hour pH-metry. All statistical elaborations were obtained using Statigraphies 5 plus for Window XP. RESULTS: There was no statistical difference regarding Lower Esophageal Sphincter (LES) pressure between patients who were H. pylori-positive and H. Pylori-negative (19.2 ± 9.5 (range: 3.7 to 46.2) and 19.7 ± 11.0 (range: 2.6 to 61), respectively). Further, no significant difference was evidenced in esophageal wave length (mean value: 3.1 seconds in H. pylori-negative patients versus 3.2 seconds in H. pylori-positive patients) or in esophageal wave height (mean value: 72.2 ± 39.3 in H. pylori-negative patients versus 67.7 ± 28.4 in H. pylori-positive patients). We observed that hiatal hernia (P = 0.01), LES opening (P = 0.05), esophageal wave length (P = 0.01) and pathological reflux number (P = 0.05) were significantly related to the presence of esophagitis. However, H. pylori infection was not significantly related to the presence of reflux esophagitis. CONCLUSIONS: Our clinical, endoscopic, manometric and pH-metric data shows no significant role of H. pylori infection in the development of GERD or in the pathogenesis of reflux esophagitis. However, current data do not provide sufficient evidence to define this relationship and further prospective large studies are needed.

Long-term results of pilonidal sinus disease with modified primary closure: new technique on 450 patients.

Chronic pilonidal disease is a debilitating condition that typically affects young adults. Controversy still exists regarding the best surgical technique for the treatment of pilonidal disease in terms of minimizing disease recurrence and patient discomfort. The present study analyzes the results of excision with our modified primary closure. This retrospective study involving consecutive patients with pilonidal disease was conducted over a 6-year period. From January 2004 to January 2010, 450 consecutive patients with primary pilonidal sinus disease received this new surgical treatment. Times for complete healing and return to work, the duration of operation and of hospitalization, postoperative pain, time to first mobilization, and postoperative complications were recorded. To evaluate patient comfort, all patients were asked to complete a questionnaire including visual analog scale. The median long-term follow-up was 54 months (range, 24 to 84 months). Four hundred fifty consecutive patients (96 female, 354 male) underwent excision. The median age was 25 years (range, 17 to 43 years). The median follow-up period was 54 months (range, 24 to 84 months). Four hundred twenty completed questionnaires were returned (87% response rate). The median duration of hospital stay was eight hours (range, 7 to 10 hours) No patient reported severe postoperative pain. Primary operative success (complete wound healing without recurrence) was achieved in 98.2 per cent. Two (0.5%) patients had a recurrence. The mean time lost to work/school after modified primary closure was eight days. Excision and primary closure with this new technique is an effective treatment for chronic pilonidal disease. It is associated with low morbidity, early return to work, and excellent cosmetic result and a high degree of patient satisfaction in the long-term follow-up.

Medical and surgical treatment of haemorrhoids and anal fissure in Crohn's disease: a critical appraisal.

BACKGROUND: The principle to avoid surgery for haemorrhoids and/or anal fissure in Crohn's disease (CD) patients is still currently valid despite advances in medical and surgical treatments. In this study we report our prospectively recorded data on medical and surgical treatment of haemorrhoids and anal fissures in CD patients over a period of 8 years. METHODS: Clinical data of patients affected by perianal disease were routinely and prospectively inserted in a database between October 2003 and October 2011 at the Department of Surgery, Tor Vergata University Hospital, Rome. We reviewed and divided in two groups records on CD patients treated either medically or surgically according to the diagnosis of haemorrhoids or anal fissures. Moreover, we compared in each group the outcome in patients with prior diagnosis of CD and in patients diagnosed with CD only after perianal main treatment. RESULTS: Eighty-six CD patients were included in the study; 45 were treated for haemorrhoids and 41 presented with anal fissure. Conservative approach was initially adopted for all patients; in case of medical treatment failure, the presence of stable intestinal disease made them eligible for surgery. Fifteen patients underwent haemorrhoidectomy (open 11; closed 3; stapled 1), and two rubber band ligation. Fourteen patients required surgery for anal fissure (Botox ± fissurectomy 8; LIS 6). In both groups we observed high complication rate, 41.2% for haemorrhoids and 57.1% for anal fissure. Patients who underwent haemorrhoidectomy without certain diagnosis of CD had significantly higher risk of complications. CONCLUSIONS: Conservative treatment of proctologic diseases in CD patients has been advocated given the high risk of complications and the evidence that spontaneous healing may also occur. From these preliminary results a role of surgery is conceivable in high selected patients, but definitve conclusions can't be made. Further randomized trials are needed to establish the efficacy of the surgical approach, giving therapeutic recommendations and guidelines.

Role of 0.4% glyceryl trinitrate ointment after haemorrhoidectomy: results of a prospective randomised study.

INTRODUCTION: Conventional haemorrhoidectomy (CH) is well known to cause significant post-operative pain and delayed return to daily activities. Both surgical wounds and sphincterial apparatus spasms are likely responsible for the pain. In this study, we evaluated the role of glyceryl trinitrate ointment (GTN) in reducing post-operative pain, ameliorating wound healing and recovery after CH. PATIENTS AND METHODS: Between 01/08 and 12/11, 203 patients with symptomatic haemorrhoids were enrolled in the study and received (103 patients) or not (100 patients) 0.4 % GTN ointment for 6 weeks after surgery. Pain was assessed using a 10-cm linear visual analogue scale (VAS). Data on post-operative pain, wound secretion and bleeding, return to normal activities and complications were recorded. Data were analysed using Fisher's exact and Mann-Whitney tests. RESULTS: GTN-treated group experienced significantly less pain during the first week after surgery (p < 0.0001). This difference was more evident starting from post-operative day 4 (p < 0.0001). A significant higher percentage of untreated patients experienced severe pain (mean VAS score > 7) (10 % vs 31 %). There were significant differences in terms of secretion time (p = 0.0052) and bleeding time (p = 0.02) in favor of GTN. In addition, the duration of itching was less in the GTN group (p = 0.0145). Patients treated with GTN were able to an early return to daily activities compared to untreated (p < 0.0001). Fifteen GTN-treated patients (14.6 %) discontinued the application because of local discomfort and headache. CONCLUSIONS: GTN ointment enhances significantly post-operative recovery, reducing pain in terms of duration and intensity. This effect might be secondary to a faster wound healing expressed by reduced secretion, bleeding and itching time.

Preoperative embolization reduces the risk of cathecolamines release at the time of surgical excision of large pelvic extra-adrenal sympathetic paraganglioma.

A 30-year-old woman with severe hypertension was admitted to the hospital with a history of headache, palpitations, and diaphoresis following sexual intercourse. Twenty-four hour urinary excretion of free catecholamines and metabolites was markedly increased as was serum chromogranin A. Computed tomography scan revealed a large mass in the left adnex site and magnetic resonance imaging confirmed the computer tomography finding, suggesting the presence of extra-adrenal sympathetic paraganglioma. I-metaiodobenzyl guanidine scintigram revealed an increased uptake in the same area. Transcatheter arterial embolization of the mass resulted in marked decreases in blood pressure and urinary excretion of free catecholamines and metabolites. Surgical excision of the mass was then accomplished without complication. Preoperative embolization is a useful and safe procedure which may reduce the risk of catecholamines release at the time of surgical excision in large pelvic extra-adrenal sympathetic paraganglioma.

Surgery for fistula-in-ano in a specialist colorectal unit: a critical appraisal.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.