Symptom Amelioration in Crohn’s Perianal Fistulas Using Video-Assisted Anal Fistula Treatment (VAAFT)

Symptom Amelioration in Crohn’s Perianal Fistulas Using Video-Assisted Anal Fistula Treatment... Abstract Background and Aims A third of patients with Crohn’s disease develop perianal fistulas. These are associated with a significant burden of symptoms and negative impact on quality of life. This study reports the use of video-assisted anal fistula treatment [VAAFT] as a means of symptom improvement; this is a minimally invasive technique to access fistula track, and diagnose/facilitate drainage of deep/complex secondary extensions with cauterization of excess inflammatory tissue. Methods Consecutive patients with complex Crohn’s fistula undergoing VAAFT for symptomatic Crohn’s anal fistula were included. They were identified from a prospectively maintained database, which was interrogated from June 2015 to November 2017. Patients underwent diagnostic fistuloscopy and fulguration of tracts/secondary extensions. Setons were sited/replaced after the procedure to maintain postoperative drainage. The primary endpoint was completion of the ‘Measure your medical outcome profile’ [MYMOP2] quality of life [QoL] questionnaire at 6 weeks postoperatively. Secondary outcome measures were a decisional regret scale [DRS], postoperative complications and the 30-day re-operation rate. Results Twenty-five patients underwent the procedure during the study period. In total, 21/25 patients [84%] provided MYMOP2 QoL data demonstrating a statistically significant improvement in both pain and discharge scores. Eighty-one per cent of patients who completed the questionnaire agreed/strongly agreed that the procedure was the right decision and no patient regretted undergoing the procedure. There was one re-operation but otherwise no complications. Conclusions This study demonstrates the feasibility, safety and importantly an improvement in patient-reported outcomes in a series of patients undergoing VAAFT for complex Crohn’s anal fistula. VAAFT reduces the main symptoms [pain and discharge] in patients with complex refractory anal fistulas. VAAFT, fistula, patient-reported outcomes 1. Introduction Perianal fistulas occur in approximately a third of all patients with Crohn’s disease [CD] and represent a distinct and aggressive phenotype.1,2 Complex Crohn’s perianal fistulas can involve a significant portion of the anal sphincter muscle, often have multiple secondary tracts/openings and can be associated with other manifestations of perianal CD.3 Treatment in this context is challenging with limited medical and surgical options for sustained cure. The introduction of anti-tumour necrosis factor [anti-TNF] agents [e.g. infliximab and adalimumab] promised improved treatment with clinical response rates of up to 68% and reported complete healing rates of 55% in the short term.4 Recent guidelines5 in the treatment of perianal fistulizing CD recommend anti-TNF agents as the current gold standard, with antibiotics and immunosuppressant agents offering a role as adjunctive treatments. Despite best medical treatment a significant number of patients either never achieve response or subsequently lose response to biological treatments. Only a third of patients with Crohn’s perianal fistula that closed on induction remain in remission on long-term maintenance treatment, and this number reduces with time.6 Surgical treatment options are limited due to the anatomical complexity limiting the sphincter-sparing options suitable.7,8 Surgical procedures aim to heal fistulas but these too have disappointing results with frequent recurrences. Each recurrence or operation can lead to tissue destruction, distorting anatomy and making subsequent procedures more challenging. In about 12–20% of cases, proctectomy may ultimately be required.9 Combined surgical and medical therapies offer improved outcomes, yet robust, sustained healing remains an elusive goal.10 Video-assisted anal fistula treatment [VAAFT] is a sphincter-sparing, minimally invasive technique,11 comprising diagnostic and operative phases. The diagnostic phase involves viewing the fistula from the inside using a fistuloscope, and identifying all secondary extensions under direct vision. As described by the original authors,11 the fistuloscope allows detection of true fistulas as distinct from false passages and facilitates intraoperative delineation of complex fistula anatomy. The operative phase employs cautery for tract ablation with various options [suture/staple closure or advancement flap] to close the internal opening. Several studies have reported ‘success’ in cryptoglandular fistulas, albeit with heterogeneous outcomes. Data on use in Crohn’s perianal fistula are sparse, with few studies evaluating this procedure. The aim, in studies published to date, is to achieve closure of the fistula. Qualitative studies reveal that with refractory disease, not only is a patient’s physical state affected, but also their emotional wellbeing, social life, educational activities, professional lives and intimate relationships.12 In the face of this impact on quality of life, there is a need to address symptom burden in those cases where definitive cure is not always achievable. Whilst robust healing of Crohn’s anal fistula with medical or surgical treatment is rare, we noticed that patients gained symptomatic benefit from VAAFT procedures, even when healing did not occur. Many patients are managed in the long term on biological agents, which control their symptoms incompletely. We hypothesized that VAAFT [performed with the intent of symptom amelioration rather than fistula closure] might further improve symptoms from Crohn’s anal fistula. In this study, we analyse the use of VAAFT as a minimally invasive technique to access the fistula track and facilitate drainage of secondary extensions with cauterization of excessive inflammatory tissue. We sought to assess the role of VAAFT as a symptomatic treatment in perianal Crohn’s fistula using patient-reported outcome measures as our primary endpoint, and secondary outcome measures of complications and 30-day re-operation. 2. Methods We performed an analysis from a prospectively maintained database of consecutive Crohn’s fistula patients undergoing VAAFT between June 2015 and November 2017. All patients had persistent fistula symptoms in the context of multiple previous procedures, previous/current use of biological therapy and complex fistulas according to the American Gastroenterological Association [AGA] classification,3 i.e. high [high intersphincteric/high trans-sphincteric or extrasphincteric or suprasphincteric origin of the fistula tract], ±multiple external openings, ±collection, ±rectovaginal fistula/anorectal stricture/active rectal disease at endoscopy. 2.1. Operative procedure Patients were placed in the lithotomy position under general anaesthesia. The fistuloscope was used to survey the fistula tract network from the external opening[s] to the internal opening[s]. The technique as described by Meinero and Mori11 was used with the exception of treatment of the internal opening which was not closed, as fistula closure was not sought. All fragments of the whitish material adhering to the fistula wall were cauterized with careful observation for secondary extensions, any abscess cavities or any possible fistula tract. Continuing under direct vision, any inflammatory or necrotic material was removed with an endo-brush and continuous jet irrigation [glycine-mannitol 1%] ensuring all waste exits via the internal or external openings. Setons were changed or sited to facilitate postoperative drainage. Patient reported outcome measures were as follows. 2.1.1. Quality of life questionnaire [‘Measure your medical outcome profile’ MYMOP] Patients completed a quality of life questionnaire using a generic [MYMOP2] quality of life questionnaire. MYMOP was developed by Paterson and initially published in 1996,6 and a revised version including items on medication was validated in 1999.7,8 Since then, the MYMOP has been used in several studies and has proven to be a sensitive measure of within-person change over time.8,9 Patients rated their two most important symptoms on a 1–6 Likert scale both pre- and postoperatively [at 6 weeks of follow up]. Pre- and postoperative MYMOP2 scores as well as decisional regret scores were then collated and expressed in spreadsheet format [using Microsoft Excel], and analysed. Any difference between their chosen MYMOP2 scores pre- and postoperatively were determined, as this difference represents the magnitude of the effect on symptoms. Secondary outcome measures were 30-day re-operation rate, to identify a tendency to provoke abscess formation, and any complications recorded on review of electronic records. 2.1.2. Decisional Regret Scale Decision regret has been associated with lower satisfaction with medical decision-making and quality of life, poorer health outcomes, and negative experiences with the healthcare system,13 thus making it a potential indicator for assessing the quality of health decisions.14–16 The validated Decisional Regret Scale [DRS]14 was used to measure distress or remorse after the decision to have surgery. The scale uses a five-item self-reported Likert scale [1, ‘strongly agree’; 2, ‘agree’; 3, ‘neither agree nor disagree’; 4, ‘disagree’; and 5, ‘strongly disagree’]. Patients completed the decisional regret questionnaires at the 6 weeks of follow-up. 3. Results A total of 25 patients underwent the VAAFT procedure for symptom improvement of Crohn’s anal fistulas between June 2015 and November 2017. The median age was 32 [range 17–64] years. Tne majority [23/25, 92%] were on biological medication with concurrent azathioprine [92%], with 32% [8/25] having been on two or more previous courses of biological treatment [Table 1]. All operations where done as day case procedures with no overnight stays. Table 1. Patient and fistula characteristics Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] IO, internal opening; EO, external opening. View Large Table 1. Patient and fistula characteristics Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] IO, internal opening; EO, external opening. View Large The procedure was completed as planned in 24/25 patients. In one patient, the planned VAAFT procedure was abandoned for routine examination under anaesthesia [EUA], due to an inability to intubate the narrow fistula tract with the fistuloscope. Patient-reported outcome measures were collected for 21/24 patients who underwent the procedure as planned, and completed MYMOP scores pre- and postoperatively [at 6 weeks] as well as decisional regret scale postoperatively. Three patients [3/24] missed their follow-up appointments and had no recorded postoperative scores. All patients who completed questionnaires chose pain and discharge as their two most important symptoms for the MYMOP2 score. Figure 1 demonstrates the pre- and postoperative MYMOP pain scores. Median preoperative pain score was 4 [range 1–6], and this result decreased to a median postoperative pain score of 1 [range 0–4]. This difference between these paired groups was statistically significant on Wilcoxon signed rank testing [p < 0.001]. Figure 1. View largeDownload slide Pre- and postoperative MYMOP pain scores. Figure 1. View largeDownload slide Pre- and postoperative MYMOP pain scores. Figure 2 demonstrates the pre- and postoperative MYMOP discharge scores. Median discharge score was 4 [range 1–6], and this decreased to a median postoperative discharge score of 1 [range 0–5]. This difference between these paired groups was also statistically significant on Wilcoxon signed rank testing [p < 0.001]. Figure 2. View largeDownload slide Pre- and postoperative MYMOP discharge scores. Figure 2. View largeDownload slide Pre- and postoperative MYMOP discharge scores. The results of completed decisional regret scales are shown in Table 2. Eighty-one per cent of patients who underwent the VAAFT procedure agreed or strongly agreed that it was the right decision and 71% agreed or strongly agreed that they would make the decision to undergo the procedure again, in the same situation. All patients disagreed or strongly disagreed with the statement that they regretted undergoing the procedure, and 95% disagreed or strongly disagreed that the choice did them harm. Table 2. Follow-up data at end of study period Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] View Large Table 2. Follow-up data at end of study period Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] View Large There was one return to theatre at 2 weeks postoperatively for an EUA due to clinical suggestion of an abscess. No abscess or collections were identified at EUA in this patient. There were no reported complications in the remaining 20 patients. 4. Discussion In this study, we used patient-reported outcome measures to determine the benefit produced by VAAFT with the intent of symptom improvement for Crohn’s perianal fistula. No attempt was made to close the fistula, the internal opening was left open and a seton was left in situ. In these patients with refractory fistula, medical treatment and seton drainage were added to the VAAFT technique, in an attempt to reduce symptoms but not to affect fistula closure. The increasingly recognized importance of improving quality of life in patients with perianal CD is further highlighted in such studies as the PISA trial, which uses quality of life as a principal outcome measure.17 Techniques to improve quality of life in patients with refractory perianal CD remain crucial where remission is not always achievable. Our study demonstrated that for complex fistulas, VAAFT was associated with a significant improvement in pain and discharge, measured using MYMOP2 6 weeks postoperatively. Fistuloscopy was feasible in 24/25 patients. In total, 81% of patients felt that undergoing VAAFT was the right decision for them and no patient regretted it. One patient returned to theatre due to increased pain and swelling, but no abscess was found. No other complications were observed. An important factor in assessing the role of this technique may derive from an improved understanding of the underlying mechanism of action, and how this addresses the pathogenesis of Crohn’s anal fistula. VAAFT and Fistula tract Laser Closure [FiLaC™] are novel therapies for definitive sphincter-sparing surgical treatment of anal fistulas, which have largely been evaluated in cryptoglandular fistula.18 The rationale behind these minimally invasive procedures, which probe the fistula tract via the external opening, is to ablate the tract either by electrocautery [VAAFT] or by laser energy [FiLaC™], damaging the lining of the tract and leaving a healthier wound behind, allowing potential tissue repair by the macrophages and fibroblasts recruited from the surrounding healthy connective tissue.19 They have the benefit of causing minimal damage to surrounding tissues, which in turn allows the opportunity for repeat procedures. The exact mechanism of action remains unknown, with no studies assessing the changes on a cellular level or in cytokine milieu, before and after treatment. There are very few studies assessing the VAAFT procedure in patients with Crohn’s anal fistula. A recent review article on VAAFT as well as other novel sphincter-sparing techniques reported a total of 917 patients undergoing VAAFT across 12 studies.18 Of these 917 patients, 21 [2%] underwent VAAFT for Crohn’s anal fistula.18,20–23 The studies reported varied treatment of the internal opening, with advancement flap in 11/21,20,23 no closure in 9/21 [VAAFT used purely for diagnosis and evaluating anatomy]22 and suture/staple in 1/21.21 Success was assessed clinically and varied across the studies and was seen in 12/21 at maximum follow-up of 9 months. Conclusions are difficult to draw given the heterogeneity in the procedure and outcome measurement, and the overall paucity of data. The largest Crohn’s series in the review was by Schwandner,23 reporting on 11 patients who had VAAFT in combination with advancement flap repair of complex fistulas in CD, with an 81% ‘success’ rate [9/11 patients]. ‘Success’ was defined clinically, closure of internal/external openings, and absence of fistula drainage/abscess formation, and this was assessed on a 3-monthly basis with maximum follow-up of 9 months. The VAAFT element was employed for diagnosis of secondary extensions with disruption of these with electrocautery or brushing. There was a diagnostic benefit noted in 64% [7/11] of patients in whom additional side tracts, not seen with preoperative clinical/endosonographic evaluation, were detected.18,23 To our knowledge, no other studies to date have used patient-reported outcomes as the primary outcome following intervention on Crohn’s anal fistula. Sahnan et al.24 highlighted an important problem with studies reporting on interventions in CD with regard to heterogeneity in outcome reporting.24 This heterogeneity significantly affects robust data synthesis across studies, making it difficult to determine the role and value of interventions in perianal CD. A core outcome set for this disease has recently been published by a national collaborative group, and the importance of patient reported outcome measures (PROMs) was emphasized in this process, and in the resulting core oucome set.25 There are some limitations to this study. This was a case series to determine feasibility and identify if any beneficial effect was produced, there was no comparative control group and hence it is not possible to exclude the placebo effect of having undergone a general anaesthetic and surgery. A sham surgery, randomized controlled trial, with optimized medical management and EUA as standard in both arms, is required to answer this question. The duration of the symptomatic effect was also not ascertained in this study and can also only be determined in a placebo-controlled trial. Anecdotally, symptoms [pain and discharge] appeared to deteriorate slowly after approximately 2 months to return to their preoperative level. Some of the patients in this study had multiple procedures [Table 3]; this was on a selective basis according to patient request following symptomatic benefit. Future studies need to assess the benefit and timing of repeated VAAFT procedures within a programme of treatment which includes optimized medical management, and determine whether this maintains an improvement in symptoms on each occasion. Clearly, a cost-effectiveness analysis would be required to assess the health economic benefits of this approach. The various aspects of this optimized package of care aiming to produce symptom improvement will develop and evolve in the coming years. Further studies reporting closure of the internal opening [whether by advancement flap, suture or staple device] would enable assessment of the curative efficacy of VAAFT for Crohn’s fistulas. VAAFT also has the potential to deliver medication to the fistula tract.26 This application has great potential in view of increasing evidence of injectable treatments such as stem cells, platelet-rich plasma and fat27–29 and also for local injection of drugs. Table 3. Decision Regret Scores for patients postoperatively Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 View Large Table 3. Decision Regret Scores for patients postoperatively Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 View Large 5. Conclusions This study introduces the concept of symptom improvement as a tool to demonstrate the efficacy of a novel use for a new surgical technique in Crohn’s anal fistula. Although there are outstanding questions to be addressed, including the mechanism of action, efficacy against placebo, duration of effect and cost effectiveness, our study suggests that VAAFT may offer symptomatic improvement for some patients with Crohn’s perianal fistula. Given the current low rates of fistula healing in response to any technique, it is imperative that the symptom burden associated with this challenging condition is addressed directly. Better patient-reported outcome measures are required for this, particularly those that relate specifically to Crohn’s anal fistula, and work is currently underway in this regard. Conference Preliminary results from this study were presented as an oral presentation at the Association of Coloproctologists of Great Britain and Ireland [ACPGBI] in July 2017; and as a poster presentation at the European Society of Coloproctologists in September 2017. Funding No specific funding was received for this study. Kapil Sahnan is supported by a Royal College of Surgeons of England Research Scholarship. Conflict of interest None. Author contributions JW, RKSP, OF, AH, PJT and SOA conceptualized the study. SOA, KS and RS collected data [patient-reported outcome questionnaires]; ODF, JW and PJT performed the operations; SOA, KS and PFCL prepared the manuscript; AH, PFCL, OF, RKSP and JW revised the manuscript critically and prepared the final version of the manuscript. All authors approved the final draft prior to submission. References 1. Economou M , Zambeli E , Michopoulos S , et al. Incidence and prevalence of Crohn’s disease and its etiological influences. Ann Gastroenterol 2009 ; 22 : 158 – 67 . 2. Ardizzone S , Porro GB . Perianal Crohn’s disease: overview . Dig Liver Dis 2007 ; 39 : 957 – 8 . Google Scholar CrossRef Search ADS PubMed 3. Sandborn WJ , Fazio VW , Feagan BG , Hanauer SB ; American Gastroenterological Association Clinical Practice Committee . AGA technical review on perianal Crohn’s disease . Gastroenterology 2003 ; 125 : 1508 – 30 . Google Scholar CrossRef Search ADS PubMed 4. Present DH , Rutgeerts P , Targan S , et al. 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Symptom Amelioration in Crohn’s Perianal Fistulas Using Video-Assisted Anal Fistula Treatment (VAAFT)

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Oxford University Press
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Copyright © 2018 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com
ISSN
1873-9946
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1876-4479
D.O.I.
10.1093/ecco-jcc/jjy071
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Abstract

Abstract Background and Aims A third of patients with Crohn’s disease develop perianal fistulas. These are associated with a significant burden of symptoms and negative impact on quality of life. This study reports the use of video-assisted anal fistula treatment [VAAFT] as a means of symptom improvement; this is a minimally invasive technique to access fistula track, and diagnose/facilitate drainage of deep/complex secondary extensions with cauterization of excess inflammatory tissue. Methods Consecutive patients with complex Crohn’s fistula undergoing VAAFT for symptomatic Crohn’s anal fistula were included. They were identified from a prospectively maintained database, which was interrogated from June 2015 to November 2017. Patients underwent diagnostic fistuloscopy and fulguration of tracts/secondary extensions. Setons were sited/replaced after the procedure to maintain postoperative drainage. The primary endpoint was completion of the ‘Measure your medical outcome profile’ [MYMOP2] quality of life [QoL] questionnaire at 6 weeks postoperatively. Secondary outcome measures were a decisional regret scale [DRS], postoperative complications and the 30-day re-operation rate. Results Twenty-five patients underwent the procedure during the study period. In total, 21/25 patients [84%] provided MYMOP2 QoL data demonstrating a statistically significant improvement in both pain and discharge scores. Eighty-one per cent of patients who completed the questionnaire agreed/strongly agreed that the procedure was the right decision and no patient regretted undergoing the procedure. There was one re-operation but otherwise no complications. Conclusions This study demonstrates the feasibility, safety and importantly an improvement in patient-reported outcomes in a series of patients undergoing VAAFT for complex Crohn’s anal fistula. VAAFT reduces the main symptoms [pain and discharge] in patients with complex refractory anal fistulas. VAAFT, fistula, patient-reported outcomes 1. Introduction Perianal fistulas occur in approximately a third of all patients with Crohn’s disease [CD] and represent a distinct and aggressive phenotype.1,2 Complex Crohn’s perianal fistulas can involve a significant portion of the anal sphincter muscle, often have multiple secondary tracts/openings and can be associated with other manifestations of perianal CD.3 Treatment in this context is challenging with limited medical and surgical options for sustained cure. The introduction of anti-tumour necrosis factor [anti-TNF] agents [e.g. infliximab and adalimumab] promised improved treatment with clinical response rates of up to 68% and reported complete healing rates of 55% in the short term.4 Recent guidelines5 in the treatment of perianal fistulizing CD recommend anti-TNF agents as the current gold standard, with antibiotics and immunosuppressant agents offering a role as adjunctive treatments. Despite best medical treatment a significant number of patients either never achieve response or subsequently lose response to biological treatments. Only a third of patients with Crohn’s perianal fistula that closed on induction remain in remission on long-term maintenance treatment, and this number reduces with time.6 Surgical treatment options are limited due to the anatomical complexity limiting the sphincter-sparing options suitable.7,8 Surgical procedures aim to heal fistulas but these too have disappointing results with frequent recurrences. Each recurrence or operation can lead to tissue destruction, distorting anatomy and making subsequent procedures more challenging. In about 12–20% of cases, proctectomy may ultimately be required.9 Combined surgical and medical therapies offer improved outcomes, yet robust, sustained healing remains an elusive goal.10 Video-assisted anal fistula treatment [VAAFT] is a sphincter-sparing, minimally invasive technique,11 comprising diagnostic and operative phases. The diagnostic phase involves viewing the fistula from the inside using a fistuloscope, and identifying all secondary extensions under direct vision. As described by the original authors,11 the fistuloscope allows detection of true fistulas as distinct from false passages and facilitates intraoperative delineation of complex fistula anatomy. The operative phase employs cautery for tract ablation with various options [suture/staple closure or advancement flap] to close the internal opening. Several studies have reported ‘success’ in cryptoglandular fistulas, albeit with heterogeneous outcomes. Data on use in Crohn’s perianal fistula are sparse, with few studies evaluating this procedure. The aim, in studies published to date, is to achieve closure of the fistula. Qualitative studies reveal that with refractory disease, not only is a patient’s physical state affected, but also their emotional wellbeing, social life, educational activities, professional lives and intimate relationships.12 In the face of this impact on quality of life, there is a need to address symptom burden in those cases where definitive cure is not always achievable. Whilst robust healing of Crohn’s anal fistula with medical or surgical treatment is rare, we noticed that patients gained symptomatic benefit from VAAFT procedures, even when healing did not occur. Many patients are managed in the long term on biological agents, which control their symptoms incompletely. We hypothesized that VAAFT [performed with the intent of symptom amelioration rather than fistula closure] might further improve symptoms from Crohn’s anal fistula. In this study, we analyse the use of VAAFT as a minimally invasive technique to access the fistula track and facilitate drainage of secondary extensions with cauterization of excessive inflammatory tissue. We sought to assess the role of VAAFT as a symptomatic treatment in perianal Crohn’s fistula using patient-reported outcome measures as our primary endpoint, and secondary outcome measures of complications and 30-day re-operation. 2. Methods We performed an analysis from a prospectively maintained database of consecutive Crohn’s fistula patients undergoing VAAFT between June 2015 and November 2017. All patients had persistent fistula symptoms in the context of multiple previous procedures, previous/current use of biological therapy and complex fistulas according to the American Gastroenterological Association [AGA] classification,3 i.e. high [high intersphincteric/high trans-sphincteric or extrasphincteric or suprasphincteric origin of the fistula tract], ±multiple external openings, ±collection, ±rectovaginal fistula/anorectal stricture/active rectal disease at endoscopy. 2.1. Operative procedure Patients were placed in the lithotomy position under general anaesthesia. The fistuloscope was used to survey the fistula tract network from the external opening[s] to the internal opening[s]. The technique as described by Meinero and Mori11 was used with the exception of treatment of the internal opening which was not closed, as fistula closure was not sought. All fragments of the whitish material adhering to the fistula wall were cauterized with careful observation for secondary extensions, any abscess cavities or any possible fistula tract. Continuing under direct vision, any inflammatory or necrotic material was removed with an endo-brush and continuous jet irrigation [glycine-mannitol 1%] ensuring all waste exits via the internal or external openings. Setons were changed or sited to facilitate postoperative drainage. Patient reported outcome measures were as follows. 2.1.1. Quality of life questionnaire [‘Measure your medical outcome profile’ MYMOP] Patients completed a quality of life questionnaire using a generic [MYMOP2] quality of life questionnaire. MYMOP was developed by Paterson and initially published in 1996,6 and a revised version including items on medication was validated in 1999.7,8 Since then, the MYMOP has been used in several studies and has proven to be a sensitive measure of within-person change over time.8,9 Patients rated their two most important symptoms on a 1–6 Likert scale both pre- and postoperatively [at 6 weeks of follow up]. Pre- and postoperative MYMOP2 scores as well as decisional regret scores were then collated and expressed in spreadsheet format [using Microsoft Excel], and analysed. Any difference between their chosen MYMOP2 scores pre- and postoperatively were determined, as this difference represents the magnitude of the effect on symptoms. Secondary outcome measures were 30-day re-operation rate, to identify a tendency to provoke abscess formation, and any complications recorded on review of electronic records. 2.1.2. Decisional Regret Scale Decision regret has been associated with lower satisfaction with medical decision-making and quality of life, poorer health outcomes, and negative experiences with the healthcare system,13 thus making it a potential indicator for assessing the quality of health decisions.14–16 The validated Decisional Regret Scale [DRS]14 was used to measure distress or remorse after the decision to have surgery. The scale uses a five-item self-reported Likert scale [1, ‘strongly agree’; 2, ‘agree’; 3, ‘neither agree nor disagree’; 4, ‘disagree’; and 5, ‘strongly disagree’]. Patients completed the decisional regret questionnaires at the 6 weeks of follow-up. 3. Results A total of 25 patients underwent the VAAFT procedure for symptom improvement of Crohn’s anal fistulas between June 2015 and November 2017. The median age was 32 [range 17–64] years. Tne majority [23/25, 92%] were on biological medication with concurrent azathioprine [92%], with 32% [8/25] having been on two or more previous courses of biological treatment [Table 1]. All operations where done as day case procedures with no overnight stays. Table 1. Patient and fistula characteristics Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] IO, internal opening; EO, external opening. View Large Table 1. Patient and fistula characteristics Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] Patient demographics  Sex [male:female] 11:14  Age, years – median [range] 32 [17–64]  Median duration of CD diagnosis, years 5.5 [0–24]  Median duration of fistula[s], years 5 [0–19]  Number of patients on biological medication 23/25 [92%]  Number of patients with ≥2 previous courses of biological medication 8/25 [32%] Presence of proctitis 6/25 [24%]  Previous surgery for fistula [including EUA] 25/25 [100%]  Median number of previous surgeries 4 [2–12] Fistula complexity  High fistula IO 12/25 [48%]  Presence of horseshoeing 10/25 [40%]  ≥1 secondary extension 25/25 [100%]  multiple IO/fistulas 9/25 [36%]  >1 EO 11/25 [44%]  Concomitant perianal disease [stricture/ulceration] 5/25 [20%] IO, internal opening; EO, external opening. View Large The procedure was completed as planned in 24/25 patients. In one patient, the planned VAAFT procedure was abandoned for routine examination under anaesthesia [EUA], due to an inability to intubate the narrow fistula tract with the fistuloscope. Patient-reported outcome measures were collected for 21/24 patients who underwent the procedure as planned, and completed MYMOP scores pre- and postoperatively [at 6 weeks] as well as decisional regret scale postoperatively. Three patients [3/24] missed their follow-up appointments and had no recorded postoperative scores. All patients who completed questionnaires chose pain and discharge as their two most important symptoms for the MYMOP2 score. Figure 1 demonstrates the pre- and postoperative MYMOP pain scores. Median preoperative pain score was 4 [range 1–6], and this result decreased to a median postoperative pain score of 1 [range 0–4]. This difference between these paired groups was statistically significant on Wilcoxon signed rank testing [p < 0.001]. Figure 1. View largeDownload slide Pre- and postoperative MYMOP pain scores. Figure 1. View largeDownload slide Pre- and postoperative MYMOP pain scores. Figure 2 demonstrates the pre- and postoperative MYMOP discharge scores. Median discharge score was 4 [range 1–6], and this decreased to a median postoperative discharge score of 1 [range 0–5]. This difference between these paired groups was also statistically significant on Wilcoxon signed rank testing [p < 0.001]. Figure 2. View largeDownload slide Pre- and postoperative MYMOP discharge scores. Figure 2. View largeDownload slide Pre- and postoperative MYMOP discharge scores. The results of completed decisional regret scales are shown in Table 2. Eighty-one per cent of patients who underwent the VAAFT procedure agreed or strongly agreed that it was the right decision and 71% agreed or strongly agreed that they would make the decision to undergo the procedure again, in the same situation. All patients disagreed or strongly disagreed with the statement that they regretted undergoing the procedure, and 95% disagreed or strongly disagreed that the choice did them harm. Table 2. Follow-up data at end of study period Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] View Large Table 2. Follow-up data at end of study period Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] Follow-up data for patients undergoing VAAFT [n = 24/25]  Duration of follow-up, months 13 [4–27]  Number of patients who underwent repeat VAAFT procedures 9  Median number [and range] of repeat VAAFT procedures 1 [0–3] View Large There was one return to theatre at 2 weeks postoperatively for an EUA due to clinical suggestion of an abscess. No abscess or collections were identified at EUA in this patient. There were no reported complications in the remaining 20 patients. 4. Discussion In this study, we used patient-reported outcome measures to determine the benefit produced by VAAFT with the intent of symptom improvement for Crohn’s perianal fistula. No attempt was made to close the fistula, the internal opening was left open and a seton was left in situ. In these patients with refractory fistula, medical treatment and seton drainage were added to the VAAFT technique, in an attempt to reduce symptoms but not to affect fistula closure. The increasingly recognized importance of improving quality of life in patients with perianal CD is further highlighted in such studies as the PISA trial, which uses quality of life as a principal outcome measure.17 Techniques to improve quality of life in patients with refractory perianal CD remain crucial where remission is not always achievable. Our study demonstrated that for complex fistulas, VAAFT was associated with a significant improvement in pain and discharge, measured using MYMOP2 6 weeks postoperatively. Fistuloscopy was feasible in 24/25 patients. In total, 81% of patients felt that undergoing VAAFT was the right decision for them and no patient regretted it. One patient returned to theatre due to increased pain and swelling, but no abscess was found. No other complications were observed. An important factor in assessing the role of this technique may derive from an improved understanding of the underlying mechanism of action, and how this addresses the pathogenesis of Crohn’s anal fistula. VAAFT and Fistula tract Laser Closure [FiLaC™] are novel therapies for definitive sphincter-sparing surgical treatment of anal fistulas, which have largely been evaluated in cryptoglandular fistula.18 The rationale behind these minimally invasive procedures, which probe the fistula tract via the external opening, is to ablate the tract either by electrocautery [VAAFT] or by laser energy [FiLaC™], damaging the lining of the tract and leaving a healthier wound behind, allowing potential tissue repair by the macrophages and fibroblasts recruited from the surrounding healthy connective tissue.19 They have the benefit of causing minimal damage to surrounding tissues, which in turn allows the opportunity for repeat procedures. The exact mechanism of action remains unknown, with no studies assessing the changes on a cellular level or in cytokine milieu, before and after treatment. There are very few studies assessing the VAAFT procedure in patients with Crohn’s anal fistula. A recent review article on VAAFT as well as other novel sphincter-sparing techniques reported a total of 917 patients undergoing VAAFT across 12 studies.18 Of these 917 patients, 21 [2%] underwent VAAFT for Crohn’s anal fistula.18,20–23 The studies reported varied treatment of the internal opening, with advancement flap in 11/21,20,23 no closure in 9/21 [VAAFT used purely for diagnosis and evaluating anatomy]22 and suture/staple in 1/21.21 Success was assessed clinically and varied across the studies and was seen in 12/21 at maximum follow-up of 9 months. Conclusions are difficult to draw given the heterogeneity in the procedure and outcome measurement, and the overall paucity of data. The largest Crohn’s series in the review was by Schwandner,23 reporting on 11 patients who had VAAFT in combination with advancement flap repair of complex fistulas in CD, with an 81% ‘success’ rate [9/11 patients]. ‘Success’ was defined clinically, closure of internal/external openings, and absence of fistula drainage/abscess formation, and this was assessed on a 3-monthly basis with maximum follow-up of 9 months. The VAAFT element was employed for diagnosis of secondary extensions with disruption of these with electrocautery or brushing. There was a diagnostic benefit noted in 64% [7/11] of patients in whom additional side tracts, not seen with preoperative clinical/endosonographic evaluation, were detected.18,23 To our knowledge, no other studies to date have used patient-reported outcomes as the primary outcome following intervention on Crohn’s anal fistula. Sahnan et al.24 highlighted an important problem with studies reporting on interventions in CD with regard to heterogeneity in outcome reporting.24 This heterogeneity significantly affects robust data synthesis across studies, making it difficult to determine the role and value of interventions in perianal CD. A core outcome set for this disease has recently been published by a national collaborative group, and the importance of patient reported outcome measures (PROMs) was emphasized in this process, and in the resulting core oucome set.25 There are some limitations to this study. This was a case series to determine feasibility and identify if any beneficial effect was produced, there was no comparative control group and hence it is not possible to exclude the placebo effect of having undergone a general anaesthetic and surgery. A sham surgery, randomized controlled trial, with optimized medical management and EUA as standard in both arms, is required to answer this question. The duration of the symptomatic effect was also not ascertained in this study and can also only be determined in a placebo-controlled trial. Anecdotally, symptoms [pain and discharge] appeared to deteriorate slowly after approximately 2 months to return to their preoperative level. Some of the patients in this study had multiple procedures [Table 3]; this was on a selective basis according to patient request following symptomatic benefit. Future studies need to assess the benefit and timing of repeated VAAFT procedures within a programme of treatment which includes optimized medical management, and determine whether this maintains an improvement in symptoms on each occasion. Clearly, a cost-effectiveness analysis would be required to assess the health economic benefits of this approach. The various aspects of this optimized package of care aiming to produce symptom improvement will develop and evolve in the coming years. Further studies reporting closure of the internal opening [whether by advancement flap, suture or staple device] would enable assessment of the curative efficacy of VAAFT for Crohn’s fistulas. VAAFT also has the potential to deliver medication to the fistula tract.26 This application has great potential in view of increasing evidence of injectable treatments such as stem cells, platelet-rich plasma and fat27–29 and also for local injection of drugs. Table 3. Decision Regret Scores for patients postoperatively Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 View Large Table 3. Decision Regret Scores for patients postoperatively Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 Decision Regret Scale items Strongly agree Agree Neither agree nor disagree Disagree Strongly disagree 1. It was the right decision 11/21 6/21 4/21 0/21 0/21 2. I regret the choice that was made 0/21 0/21 0/21 8/21 13/21 3. I would make the same choice if I had to do it over again 9/21 6/21 6/21 0/21 0/21 4. The choice did me a lot of harm 0/21 0/21 1/21 4/21 16/21 5. The decision was a wise one 10/21 5/21 6/21 0/21 0/21 View Large 5. Conclusions This study introduces the concept of symptom improvement as a tool to demonstrate the efficacy of a novel use for a new surgical technique in Crohn’s anal fistula. Although there are outstanding questions to be addressed, including the mechanism of action, efficacy against placebo, duration of effect and cost effectiveness, our study suggests that VAAFT may offer symptomatic improvement for some patients with Crohn’s perianal fistula. Given the current low rates of fistula healing in response to any technique, it is imperative that the symptom burden associated with this challenging condition is addressed directly. Better patient-reported outcome measures are required for this, particularly those that relate specifically to Crohn’s anal fistula, and work is currently underway in this regard. Conference Preliminary results from this study were presented as an oral presentation at the Association of Coloproctologists of Great Britain and Ireland [ACPGBI] in July 2017; and as a poster presentation at the European Society of Coloproctologists in September 2017. Funding No specific funding was received for this study. Kapil Sahnan is supported by a Royal College of Surgeons of England Research Scholarship. Conflict of interest None. Author contributions JW, RKSP, OF, AH, PJT and SOA conceptualized the study. SOA, KS and RS collected data [patient-reported outcome questionnaires]; ODF, JW and PJT performed the operations; SOA, KS and PFCL prepared the manuscript; AH, PFCL, OF, RKSP and JW revised the manuscript critically and prepared the final version of the manuscript. All authors approved the final draft prior to submission. References 1. Economou M , Zambeli E , Michopoulos S , et al. Incidence and prevalence of Crohn’s disease and its etiological influences. Ann Gastroenterol 2009 ; 22 : 158 – 67 . 2. Ardizzone S , Porro GB . Perianal Crohn’s disease: overview . Dig Liver Dis 2007 ; 39 : 957 – 8 . Google Scholar CrossRef Search ADS PubMed 3. Sandborn WJ , Fazio VW , Feagan BG , Hanauer SB ; American Gastroenterological Association Clinical Practice Committee . AGA technical review on perianal Crohn’s disease . Gastroenterology 2003 ; 125 : 1508 – 30 . Google Scholar CrossRef Search ADS PubMed 4. Present DH , Rutgeerts P , Targan S , et al. 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Journal

Journal of Crohn's and ColitisOxford University Press

Published: Sep 1, 2018

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