The primary aim of the European Society of Coloproctology (ESCP) Guideline Development Group (GDG) was to produce high-quality, evidence-based guidelines for the management of cryptoglandular anal fistula with input from a multidisciplinary group and using transparent, reproducible methodology.

Previously published methodology in guideline development by the ESCP has been replicated in this project. The guideline development process followed the requirements of the AGREE-S tool kit. Six phases can be identified in the methodology. Phase one sets the scope of the guideline, which addresses the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula in adult patients presenting to secondary care. The target population for this guideline are healthcare practitioners in secondary care and patients interested in understanding the clinical evidence available for various surgical interventions for anal fistula. Phase two involved formulation of the GDG. The GDG consisted of 21 coloproctologists, three research fellows, a radiologist and a methodologist. Stakeholders were chosen for their clinical and academic involvement in the management of anal fistula as well as being representative of the geographical variation among the ESCP membership. Five patients were recruited from patient groups to review the draft guideline. These patients attended two virtual meetings to discuss the evidence and suggest amendments. In phase three, patient/population, intervention, comparison and outcomes questions were formulated by the GDG. The GDG ratified 250 questions and chose 45 for inclusion in the guideline. In phase four, critical and important outcomes were confirmed for inclusion. Important outcomes were pain and wound healing. Critical outcomes were fistula healing, fistula recurrence and incontinence. These outcomes formed part of the inclusion criteria for the literature search. In phase five, a literature search was performed of MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews by eight teams of the GDG. Data were extracted and submitted for review by the GDG in a draft guideline. The most recent systematic reviews were prioritized for inclusion. Studies published since the most recent systematic review were included in our analysis by conducting a new meta-analysis using Review manager. In phase six, recommendations were formulated, using grading of recommendations, assessment, development, and evaluations, in three virtual meetings of the GDG.

In seven sections covering the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula, there are 42 recommendations.

This is an up-to-date international guideline on the management of cryptoglandular anal fistula using methodology prescribed by the AGREE enterprise.

Evaluation of the effectiveness and tolerability of the application of an OTSC (Ovesco Endoscopy AG Tuebingen, Germany) Proctology clip as an innovative strategy of anorectal fistulae closure when established treatment strategies had already failed or were not feasible.

Retrospective single-center study including consecutive patients treated between March 2014 and March 2016 with the OTSC Proctology system for anorectal fistula closure, including one rectovaginal and one rectourethral fistula. The primary outcome was the healing rate with a minimum follow up of 6 months. Healing was defined as closure of the internal fistula ostium and absence of secretion or local inflammation during follow up.

A total of 66 fistula closures by the OTSC Proctology clip were investigated, including cryptoglandular fistulas (45/66 patients, 68%), fistulas associated with CED (19/66 patients, 29%), and other non-cryptoglandular fistulas (2/66 patients, 4%). 47% (31/66 patients) had a failed previous therapy. In that selected collective, a successful fistula closure was achieved in 29/66 cases (44%) after a median follow up time of 40 months (6-61 months). Suprasphincteric and high transsphincteric fistulas showed healing in 63% and 42% in CD associated fistulas.

Fistula closure by the OTSC Proctology clip is an innovative, sphincter protecting treatment strategy in anorectal fistulas that can achieve long-term cure in complex anorecta.

Perianal Crohn's disease is associated with decreased quality of life, high morbidity, and high health care use. Treatment goals are to provide infection control, stop fistula drainage, and heal fistula tracts while preserving the anorectal sphincter. Treatment includes a combination of medical and surgical intervention, but new techniques are using interventional endoscopy to act as either a bridge to surgery or to decrease the need for surgical intervention. The decision on which approach to pursue requires knowledge of prior surgery, altered anatomy, prior fistula treatment, and imaging and endoscopic evaluation of fistula complexity, mucosal involvement, and associated stricture or abscess.

Crohn's anal fistula is a challenging condition, and may require multiple surgical procedures. To replicate successful procedures, these must be adequately reported in the literature. The aim of this study was to review the quality of reporting of components of surgical interventions for Crohn's anal fistula.

A systematic review was conducted. It was registered with PROSPERO (CRD:42019135157). The Medline and EMBASE databases were searched for studies reporting interventions intended to close fistula in patients with Crohn's disease, published between 1999 and August 2019. Abstracts and full texts were screened for inclusion by two reviewers. Dual extraction of data was performed to compare reporting to the TIDiER and Blencowe frameworks for reporting of interventions.

Initial searches identified 207 unique studies; 38 full texts were screened for inclusion and 33 were included. The most common study design was retrospective cohort (17/33), and the most frequently reported interventions were anal fistula plug (n = 8) and fibrin glue (n = 6). No studies showed coverage of all domains of TIDieR. Reporting was poor among domains related to who provided an intervention, where it was provided, and how it was tailored. Reporting of domains in the Blencowe framework was poor; the majority of studies did not report the component steps of procedures or efforts to standardise them.

This study demonstrates that reporting on technical aspects of interventions for Crohn's anal fistula is poor. Surgeons should aim to improve reporting to allow accurate reproduction of techniques both in clinical practice and in clinical trials.

The over-the-scope clip (OTSC) system has been increasingly utilized as a non-surgical option to endoscopically manage refractory gastrointestinal (GI) hemorrhage, perforations/luminal defects and fistulas. Limited data exist evaluating the efficacy and safety of OTSC.

To determine the clinical success and adverse event (AE) rates of OTSC across all GI indications.

A PubMed search was conducted for eligible articles describing the application of the OTSC system for any indication in the GI tract. Any article or case series reporting data for less than 5 total patients was excluded. The primary outcome was the rate of clinical success. Secondary outcomes included: Technical success rate, OTSC-related AE rate and requirement for surgical intervention despite-OTSC placement. Pooled rates (per-indication and overall) were calculated as the number of patients with the event of interest divided by the total number of patients.

A total of 85 articles met our inclusion criteria (n = 3025 patients). OTSC was successfully deployed in 94.4% of patients (n = 2856/3025). The overall rate of clinical success (all indications) was 78.4% (n = 2371/3025). Per-indication clinical success rates were as follows: (1) 86.0% (1120/1303) for GI hemorrhage; (2) 85.3% (399/468) for perforation; (3) 55.8% (347/622) for fistulae; (4) 72.6% (284/391) for anastomotic leaks; (5) 92.8% (205/221) for defect closure following endoscopic resection (e.g., following endoscopic mucosal resection or endoscopic submucosal dissection); and (6) 80.0% (16/20) for stent fixation. AE's related to the deployment of OTSC were only reported in 64 of 85 studies (n = 1942 patients), with an overall AE rate of 2.1% (n = 40/1942). Salvage surgical intervention was required in 4.7% of patients (n = 143/3025).

This systematic review demonstrates that the OTSC system is a safe and effective endoscopic therapy to manage GI hemorrhage, perforations, anastomotic leaks, defects created by endoscopic resections and for stent fixation. Clinical success in fistula management appears limited. Further studies, including randomized controlled trials comparing OTSC with conventional and/or surgical therapies, are needed to determine which indication(s) are the most effective for its use.

Perianal sepsis is a common condition ranging from acute abscess to chronic anal fistula. In most cases, the source is considered to be a non-specific cryptoglandular infection starting from the intersphincteric space. Surgery is the main treatment and several procedures have been developed, but the risks of recurrence and of impairment of continence still seem to be an unresolved issue. This statement reviews the pertinent literature and provides evidence-based recommendations to improve individualized management of patients.

The over-the-scope clip proctology system is rather new and information regarding its use for the closure of anorectal fistulas is scarce. No study has been designed to focus exclusively on its application in the treatment of rectovaginal fistulas. The aim of the study was to evaluate the feasibility, safety, and effectiveness of the clip for rectovaginal fistula repair.

From September 2014 to November 2017, consecutive patients underwent a rectovaginal fistula repair using the over-the-scope clip proctology system and were enrolled in a non-randomized prospective monocentric study. The primary outcome was fistula healing at 8 months. Secondary outcomes included assessment of morbidity and timing of rectovaginal fistula recurrence.

There were 16 patients with a median age of 40.1 years. The most common causes of rectovaginal fistula were adverse events following proctectomy or pelvic radiotherapy (6 patients), obstetric trauma (5 patients) and inflammatory bowel disease (3 patients). Most participants had undergone at least two previous surgical interventions before the clipping procedure. 11 patients had a temporary diverting stoma at time of the clipping procedure. Successful primary healing of the fistula was observed in 7 (43.7%) patients. Short-term complications were rare and included pain, which occurred in 4 patients, and spontaneous clip detachment, which occurred in 2 patients. Most recurrences appeared shortly after the procedure, with a median delay of 45 days (range 16-217).

We demonstrated the feasibility, safety, and reproducibility of the Over-The-Scope Clip Proctology system in rectovaginal fistula repair for the patients selected. Further trials should be designed, incorporating comparisons to well-established techniques, a longer follow-up period, and a larger cohort.

OTSC Proctology is a minimally invasive sphincter-preserving technique for the surgical treatment of anorectal fistulas. It is based on a super-elastic Nitinol clip which closes the internal fistula opening to allow healing of the fistula tract. A systematic search of the literature was undertaken to identify publications about OTSC Proctology. All studies and reports identified were reviewed and evaluated to determine the feasibility, efficacy and safety of clip surgery. The assessment of all available studies with a total of more than 200 surgical cases strongly suggests that the clip procedure is safe and effective with a low rate of complications. The technique rendered convincing short and long term results with an overall healing rate of approximately 63%. Best results were achieved when OTSC Proctology was used as first-line treatment (healing rate 74%) and for cryptoglandular fistulas (healing rate 64%). However, its future clinical role for IBD-associated recurrent and anorecto-vaginal fistulas remains to be determined, due to a relatively low number of these patients in the evaluated studies. OTSC Proctology is part of the novel armamentarium for the treatment for anorectal fistulas, which is based on high-technology devices. They can be repeatedly used and even combined without causing irreversible sphincter damage.

Over-the-scope-clip (OTSC) System is a relatively new endoluminal intervention for gastrointestinal (GI) leaks, fistulas, and bleeding. Here, we present a single center experience with the device over the course of 4 years.

Retrospective chart review was conducted for patients who received endoscopic OTSC treatment. Primary outcome is the resolution of the original indication for clip placement. Secondary outcomes are complications and time to resolution.

Forty-one patients underwent treatment with the OTSC system from 2011 to 2015 with average follow-up of 152 days. The average age is 53.7. The most common site of clip placement was in the stomach (44%). Clips were placed after surgical complication for 28 patients (68%), endoscopic complications for 8 patients (19%), and spontaneous presentation in 5 patients (12%). Technical success was achieved in all patients. Overall, 34 patients (83%) were successfully treated. Nine patients required multiple clips and three patients required additional treatment modalities after OTSC. Four patients used the OTSC as a bridging therapy to surgery. Using OTSC for palliation versus nonpalliative indications was associated with lower rates of treatment success (50% versus 86%, P = .028). Using OTSC for symptoms <6 months had higher rates of treatment success than those experiencing longer symptoms (88% versus 65%, P = .045). There were no major morbidities or mortalities directly associated with the OTSC system. Complications from clip use were pain in two patients (5%) and hematemesis in one patient (3%).

The OTSC System can be a very successful treatment for iatrogenic or spontaneous GI leaks and bleeds. Treatment success is more likely in patients treated within 6 months of diagnosis and less likely to when used for palliation. It was also successfully used as bridging therapy in several patients.

The surgical treatment of complex anal fistulae, particularly those involving a significant portion of the anal sphincter in which fistulotomy would compromise continence, is challenging. Video-assisted anal fistula treatment (VAAFT), fistula tract laser closure (FiLaC™) and over-the-scope clip (OTSC®) proctology system are all novel sphincter-sparing techniques targeted at healing anal fistulae. In this study, all published articles on these techniques were reviewed to determine efficacy, feasibility and safety.

A systematic search of major databases was performed using defined terms. All studies reporting on experience of these techniques were included and outcomes (fistula healing and safety) evaluated.

Eighteen studies (VAAFT-12, FiLaC™-3, OTSC®-3) including 1245 patients were analysed. All were case series, and outcomes were heterogeneous with follow-up ranging from 6 to 69 months and short-term (< 1 year) healing rates of 64-100%. Morbidity was low with only minor complications reported. There was one report of minor incontinence following the first reported study of FiLaC™, and this was treated successfully at 6 months with rubber band ligation of hypertrophied prolapsed mucosa. There are inconsistencies in the technique in studies of VAAFT and FiLaC™.

All three techniques appear to be safe and feasible options in the management of anal fistulae, and short-term healing rates are acceptable with no sustained effect on continence. There is, however, a paucity of robust data with long-term outcomes. These techniques are thus welcome additions; however, their long-term place in the colorectal surgeon's armamentarium, whether diagnostic or therapeutic, remains uncertain.

The treatment of complex anocutaneous fistulas remains a major therapeutic challenge balancing the risk of incontinence against the chance of permanent closure.

The purpose of this study was to investigate the efficacy of a nitinol proctology clip for closure of complex anocutaneous fistulas.

This is a single-center cohort study with retrospective analysis of all of the treated patients.

Data were obtained from patient records and MRI reports, as well as follow-up telephone calls and clinical follow-up with endoanal ultrasonography.

All of the patients were treated for high transsphincteric and suprasphincteric anocutaneous fistulas at the Digestive Disease Center, Bispebjerg Hospital, between May 2013 and February 2015.

All of the patients were treated with the nitinol proctology clip.

Primary outcome was fistula healing after proctology clip placement, as evaluated through clinical examination, endoanal ultrasonography, and MRI.

The fistula healing rate 1 year after the clip procedure was 54.3% (19 of 35 included patients). At the end of follow-up, 17 (49%) of 35 patients had persistent closure of the fistula tracks. No impairment of continence function was observed. Treatment outcome was not found to be statistically associated with any clinicopathological characteristics.

The study is limited by its retrospective and nonrandomized design. Selection bias may have occurred, because treatment options other than the clip were available during the study period. The small number of patients means that there is a nonnegligible risk of type II error in the conclusion, and the follow-up may be too short to have detected all of the failures.

Healing rates were comparable with those of other noninvasive, sphincter-sparing techniques for high-complex anocutaneous fistulas, with no risk of incontinence. Predictive parameters for fistula healing using this technique remain uncertain. See Video Abstract at http://links.lww.com/DCR/A347.

Treatment failure of anal fistula results in high re-occurrence rate.

Efficacy and safety of a nitinol closure clip system (bear-claw clip) were evaluated for anal fistulae treatment in a 36-month long-term follow-up study.

Twenty-two patients were included. No patient had been treated with a bear-claw clip system before. All patients were fully continent before treatment. Follow-up time was 36 months (range 19-48 months). We observed a re-occurrence rate of 41% (nine patients) with presence of an active fistula. Time to recurrence was on average 6.9 months (range 3-11 months). Thirteen patients (59%) showed a complete healing of the fistula. Placed clip was removed in all patients on average after almost 5.8 months (3-12 months), in three cases the clip was left in situ. We did not observe any incontinence; one patient reported recurrent burning after defecation once the clip system was removed.

Clip placement is a minimally invasive sphincter-preserving procedure with minimal complications and with an acceptable recurrence rate in the long term. However, bear-claw clip placement should probably be offered patients as a treatment option before more invasive procedures with higher perioperative morbidity are taken into consideration.

Anoscrotal fistula is an extremely rare condition involving an epithelialised tract between the anal canal and scrotal wall. It is more commonly seen as a congenital phenomenon in the paediatric population, and has not previously been described in the literature in adults. We present the case of a man aged 52 years who developed a complex anoscrotal fistula after a radical inguinal orchidectomy for an intratesticular seminoma. A postsurgical wound-site infection developed into a chronically discharging wound refractory to antibiotic treatment prompting further investigation. By way of MRI, a 10 cm long trans-sphincteric anoscrotal fistula was found. The patient was successfully treated by fistuloscopic curettage, internal closure using an Ovesco clip, and negative pressure dressing. We present for the first time a rare anoscrotal fistula in an adult.

Management of complex perineal fistulas such as high perianal, rectovaginal, pouch-vaginal, rectourethral, or pouch-urethral fistulas requires a systematic approach. The first step is to control any sepsis with drainage of abscess and/or seton placement. Patients with large, recurrent, irradiated fistulas benefit from stoma diversion. In patients with Crohn's disease, it is essential to induce remission prior to any repair. There are different approaches to repair complex fistulas, from local repairs to transperineal and transabdominal approaches. Simpler fistulas are amenable to local repair. More complex fistulas, such as those secondary to irradiation, require interposition of healthy, well-vascularized tissue. The most common flap used for this treatment is the gracilis muscle with good outcomes reported. Once healing is confirmed by imaging and endoscopy, the stoma is reversed.

Complex anal fistulas are responsible for pain, faecal incontinence and impaired quality of life. The rectal mucosa advancement flap (RMAF) procedure to cover the internal opening of the fistula remains a strategy of choice. However, a new procedure for closing anal fistulas is now available with the use of a nitinol closure clip (OTSC Proctology, OVESCO), which should ensure a better healing rate. This procedure is currently becoming more widespread, though without robust scientific validation, and it is therefore essential to carry out a prospective evaluation in order to determine the efficacy and safety of this new medical device for complex anal fistulas.

The FISCLOSE trial is aimed at evaluating the efficacy and safety of a nitinol closure clip compared to the RMAF procedure for the management of complex anal fistulas. This trial is a prospective, randomised, controlled, single-blind, bicentre and interventional study. Patients (n=46 per group) will be randomly assigned for management with either a closure clip or RMAF. The main objectives are to improve the healing rate of the anal fistula, lessen the postoperative pain and faecal incontinency, enhance the quality of life, and lower the number of reinterventions and therapeutic management costs. The primary outcome is the proportion of patients with a healed fistula at 3 months. The secondary outcomes are anal fistula healing (6 and 12 months), proctological pain (visual analogue scale), the faecal incontinence score (Jorge and Wexner questionnaire), digestive disorders and quality of life (Gastrointestinal Quality of Life Index and Euroqol EQ5D-3 L) up to 1 year.

The study was approved by an independent medical ethics committee 1 (IRB00008526, CPP Sud-Est 6, Clermont-Ferrand, France) and registered by the competent French authority (ANSM, Saint Denis, France). The results will be disseminated in a peer-reviewed journal and presented at international congresses.

NCT02336867; pre-result.