Protocol of the LATFIA trial (Laser Assisted Treatment of Fistula in Ano): a multicentre, prospective, randomized controlled trial comparing fistula-tract laser closure (FiLaC™) with rectal advancement flap for high trans-sphincteric fistulas.

AIM: Anal fistula is one of the most common anal diseases, affecting between 1 and 3 per 10 000 people per year. Symptoms have a potentially severe effect on a patient's quality of life. Surgery is the mainstay of treatment, aiming to cure the fistula and preserve anal sphincter function. Rectal advancement flap (RAF) is currently the gold standard treatment but has recurrence rates varying between 20% and 50% and might lead to disturbance of continence. The aim of the trial described in this work is to discover if the minimally invasive fistula tract laser closure (FiLaC™) technique could achieve higher healing rates and a better functional outcome than RAF. METHOD: We will perform a randomized prospective multicentre noninferiority study of the treatment of high trans-sphincteric perianal fistulas, comparing FiLaC™ with RAF in terms of fistula healing, recurrence rate, functional outcome and quality of life. Primary and secondary fistula healing will be evaluated at 26 and 52 weeks' follow-up. Quality of life will be evaluated using the SF-36 questionnaire, the Faecal Incontinence Quality of Life Scale questionnaire and the Vaizey score at 3, 6, 12 and 26 weeks postoperatively. CONCLUSION: High trans-sphincteric fistulas have a potentially severe effect on a patient's quality of life. Classical treatment with RAF is a time-consuming invasive procedure. The LATFIA trial aims to compare FiLaC™ with the gold standard treatment with RAF. In case of noninferiority, FiLaC™ treatment could be standardized as a first line treatment for high trans-sphincteric fistulas. Better conservation of the patient's anal sphincter function could possibly be obtained. Likewise, we will report on the postoperative quality of life when applying these two techniques.

Treatment of cryptoglandular fistulas with the fistula tract laser closure (FiLaC™) method in comparison with standard methods: first results of a multicenter retrospective comparative study in the Netherlands.

BACKGROUND: Current surgical closure techniques for sphincter-sparing treatment of high cryptoglandular fistulas in the Netherlands include the mucosal advancement flap procedure (MAF) and ligation of the intersphincteric fistula tract (LIFT). A relatively novel treatment is the fistula tract laser closure (FiLaC™) method. The aim of this study was to investigate the differences in healing and recurrence rates between FiLaC™ and current standard practices. METHODS: This multicenter retrospective cohort study included both primary and recurrent high cryptoglandular anorectal fistulas, treated with either FiLaC™ or standard methods (MAF or LIFT) between September 2015 and July 2020. Patients with extrasphincteric fistulas, Crohn's disease, multiple fistulas, age < 18 years or missing data regarding healing time or recurrence were excluded. The primary outcomes were the clinical primary and secondary healing and recurrence rates. Primary healing was defined as a closed external opening without fluid discharge within 6 months of treatment on examination, while secondary healing was the same endpoint after secondary treatment. Secondary outcomes included healing time and complaints. RESULTS: A total of 162 high fistulas from 3 Dutch hospitals were included. Ninety-nine high fistulas were treated with FiLaC™ and 63 with either MAF or LIFT. There were no significant differences between FiLaC™ and MAF/LIFT in terms of clinical healing (55.6% versus 58.7%, p = .601), secondary healing (70.0% versus 69.2%, p = .950) or recurrence rates (49.5% versus 54%, p = .420), respectively. Median follow-up duration was 7.1 months in the FiLaC™ group (interquartile range [IQR] 4.1-14.4 months) versus 6 months in the control group (IQR 3.5-8.1 months). CONCLUSIONS: FiLaC™ treatment of high anorectal fistulas does not appear to be inferior to MAF or LIFT. Based on these preliminary results, FiLaC™ can be considered as a worthwhile treatment option for high cryptoglandular fistulas. Prospective studies with a longer follow-up period and well-determined postoperative parameters such as complication rates, magnetic resonance imaging for confirmation of fistula healing, incontinence and quality of life are warranted.

Efficacy and safety of FiLaC™ for perianal fistulizing Crohn's disease: a systematic review and meta-analysis.

BACKGROUND: Most patients with perianal fistulizing Crohn's disease (pfCD) present with complex types of perianal fistulas and need repetitive repair operations, resulting in a high risk of sphincter injury. Fistula-tract Laser Closure (FiLaC™) is a novel sphincter-saving technique that obliterates the fistula tract with a photothermal effect. The aim of the present systematic review and meta-analysis was to evaluate the efficacy and safety of FiLaC in pfCD. METHODS: This study was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases, including PubMed, Embase, Cochrane Library and Wanfang Data were searched for published articles from January 2000 to June 2021. The clinicaltrials.gov website was searched for completed or ongoing trials on pfCD and FiLaC™. The references of each article were also searched for eligible data. The main outcome was the primary healing rate of the FiLaC™ procedure. Additionally, fecal incontinence was analyzed as the secondary outcome to evaluate the safety of FiLaC™. RESULTS: Six studies met the eligibility criteria and were included in the final analysis. All studies were published within the past 6 years and came from European countries. There were 50 pfCD patients recruited, and 31 patients' fistulas were healed after FiLaC™. The pooled primary healing rate was 68% (95% CI 53.0-84.0%, I2 = 27%, p = 0.23). There was no major fecal incontinence after surgery. CONCLUSIONS: These data suggest that FiLaC™ may be an effective and safe procedure for pfCD patients. However, the evidence is poor and there is a need for more high-quality prospective controlled studies with long-term follow-up before this minimally invasive technique is recommended for surgical treatment of pfCD.

[Modern surgical technologies in the treatment of patients with chronic paraproctitis]. / Sovremennye khirurgicheskie tekhnologii v lechenii bol'nykh khronicheskim paraproktitom.

The development of minimally invasive surgical technologies in the treatment of chronic paraproctitis is a promising young trend in coloproctology. Increasingly, in clinical practice, coloproctologists use laser technologies in the outpatient treatment of extra- and transsphincteric pararectal fistulas, in particular, laser technology FiLaC (Fistula Laser Closure). OBJECTIVE: Conducting a comparative retrospective and prospective cohort study of immediate and long-term results of treatment of complicated transsphincteric and extrasphincteric fistulas using the developed modified FiLaC technology with the «traditional¼ FiLaC technology, and standard excision of the fistulous tract with plasty of the internal fistula opening with a full-thickness flap of the rectal wall. MATERIAL AND METHODS: The study included 270 patients with trans- and extrasphincter pararectal fistulas, which were divided into three groups. In group 1 (n=90) the traditional FiLaC technology was used for the treatment of fistulas, in group 2 (n=90) the modified FiLaC technology was used, providing for the opening of purulent streaks and laser coagulation (FiLaC) of the intrasphincter part of the fistula with a Biolitec laser, 12 W, 100 J/cm, in group 3 (n=90), excision of the fistula tract with plastic surgery of the internal fistula opening with a full-thickness flap of the rectal wall was used. RESULTS: The results of treatment in patients of the three groups were monitored for 19-36 months. after surgery (median 31 months). The analysis of the results showed that in group 2 (modified FiLaC technology) healing of fistulas occurred faster (7.3±0.5 weeks versus 12.6±0.7 weeks) compared to group 3 (excision of the fistula with plasty of the internal fistula opening). The indicators of sphincterometry in the long-term period in patients of the 2nd group were restored in relation to the initial ones, and in the th group 3 they were reduced compared to the initial values. Postoperative complications were most common in patients of group 3 (32.2%), and least often in patients of group 2 - 8.9%. At the same time, late postoperative complications were most common (24.4%) in patients of group 1. None of the patients in group 2 had late postoperative complications, while 11.1% of postoperative complications were recorded in group 3. In patients who underwent excision of the AC (group 3), relapses were most common: early - 15.6%, late - in 21.1%. The least frequent relapses were observed in patients who underwent modified FiLaC technology (Group 2): 6.7% - early relapses and 11.1% - late relapses. CONCLUSION: The use of the modified FiLaC technology in the treatment of trans- and extrasphincteric fistulas of the rectum made it possible to minimize postoperative complications, fully preserve the function of anal holding, and achieve healing of fistulas in 82.5% of cases with a median follow-up of 31 months.

Treatment of anal fistula with FiLaC®: results of a 10-year experience with 175 patients.

BACKGROUND: Treatment of fistula-in-ano with fistula laser closure (FiLaC®) is a sphincter-saving procedure indicated for patients with complex anal fistulas. The aim of our study was to evaluate the clinical results of a 10-year experience with FiLaC®. METHODS: Data from patients with cryptoglandular anal fistula who underwent laser closure with FiLaC® in June 2009-May 2019 were evaluated. The primary study endpoint was healing rate. Secondary endpoints were evaluation of morbidity and assessment of possible predictive factors of failure. RESULTS: Out of a total of 180 patients, 5 had been lost to follow-up. 175 patients [m:f: 115:60; median age 49 years (range18-81 years)] with cryptoglandular fistulas treated with FiLaC® were included in the study. Fistulas were transphincteric in 152 (86.8%) cases, intersphincteric in 18 (10.3%), and suprasphincteric in 5 (2.9%). A seton or draining silicon loop was placed in 142 (81.8%) patients at a median of 14 weeks (range10-28 weeks) prior to FiLaC®. At median follow-up of 60 months (range 9-120 months), the overall primary healing rate was 66.8% (117/175). Thirty-eight patients (21.7%) failed to heal. Twenty out of 175 (11.4%) patients had recurrence at median follow-up of 18 months (range 9-50 months). Patients in whom a seton/loop was inserted for drainage at the first-stage procedure had a statistically significant higher rate of success (100/142, 70.4% vs. 17/33, 51.5%, respectively; p 0.0377; odds ratio 0.45). Forty-eight patients were reoperated on at a median of 15 months (range 12-20 months) after laser treatment. Twenty-six underwent redo laser closure with FiLaC®, and 12 of them healed (46%), for a secondary success rate of 73.7%. CONCLUSIONS: Longer follow-up confirms the efficacy of FiLaC® in the treatment of complex anal fistulas. Its use and implementation should be encouraged.

Sphincter-saving therapy for fistula-in-ano: long-term follow-up after FiLaC®.

BACKGROUND: The treatment of anal fistula remains a challenge between maintaining continence and radical surgery to prevent recurrence. Fistula-tract Laser Closure (FiLaC®) is a sphincter-saving technique using a radial emitting laser fibre to close the fistula tract. The aim of this study was to report long-term outcomes in patients who received FiLaC® therapy for transsphincteric and intersphincteric anal fistula between January 2011 and December 2017. METHODS: A retrospective study was performed on patients who were treated with FiLaC®- for a transsphincteric and intersphincteric anal fistula at our institution between January 2011 and December 2017. In all patients, the FiLaC® procedure was combined with a closure of the internal orifice using a simple 3-0 Z stitch. Patient characteristics, previous proctological history, healing rates, failures and postoperative continence were investigated. RESULTS: The study included 83 patients [mean age 50.01 ± 14.59 years. 64 (77.1%) males] with a mean follow-up period of 41.99 (± 21.59) months (range 4-87 months). Thirteen patients (15.7%) had a recurrent fistula. 65 patients (78.3%) had undergone prior abscess drainage with insertion of a seton. The primary healing rate was 74.7% (62 of 83 patients) overall. Eleven (13.3%) of the 21 patients (25.3%) who failed FiLaC®-therapy underwent a second operation. In eight cases, Re-FiLaC® and in three cases, fistulectomy with closure of the internal orifice was performed. Afterwards 6 (54.5%) of these 11 patients could be considered cured: 3 who had fistulectomy and three who had Re-FiLaC® treatment. The overall healing rate after second FiLaC® was 78.3% (65 of 83 patients) while the overall healing rate for FiLaC® therapy combined with any second procedure was 81.9% (68 of 83 patients). The follow-up period in this group of 11 patients who received re-operation was 38 months (range 13-84 months). Changes in continence occurred in eight patients (9.6%). No patient reported major incontinence postoperatively. CONCLUSIONS: The FiLaC® procedure is associated with good healing rates in long-term follow-up and should be considered as a treatment option for transsphincteric and intersphincteric anal fistulae, especially due to the low complication rate and low risk of sphincter injury.

Could FiLaC™ be effective in the treatment of anal fistulas? A systematic review of observational studies and proportional meta-analysis.

AIM: Fistula Laser Closure (FiLaC™) is a novel sphincter-preserving technique that is based on new technologies and shows promising results in repairing anal fistulas whilst maintaining external sphincter function. The aim of the present meta-analysis is to present the efficacy and the safety of FiLaC™ in the management of anal fistula disease. METHOD: The present proportional meta-analysis was designed using the PRISMA and AMSTAR guidelines. We searched MEDLINE, Scopus, clinicaltrials.gov, Embase, Cochrane Central Register of Controlled Trials CENTRAL and Google Scholar databases from inception until November 2019. RESULTS: Overall, eight studies were included that recruited 476 patients. The pooled success rate of the technique was 63% (95% CI 50%-75%). The pooled complication rate was 8% (95% CI 1%-18%). Sixty-six per cent of patients had a transsphincteric fistula and 60% had undergone a previous surgical intervention, mainly the insertion of a seton (54%). The majority had a cryptoglandular fistula. Operation time and follow-up period were described for each study. CONCLUSION: FiLaC™ seems to be an efficient therapeutic option for perianal fistula disease with an adequate level of safety that preserves quality of life. Nevertheless, randomized trials need to be designed to compare FiLaC™ with other procedures for the management of anal fistulas such as ligation of intersphincteric fistula tract, anal advancement flaps, fibrin glue, collagen paste, autologous adipose tissue, fistula plug and video-assisted anal fistula treatment.

Assessing the effectiveness of laser fistulectomy for anal fistula: a retrospective cohort study.

BACKGROUND: Laser fistulectomy is a minimally invasive, sphincter-sparing procedure for treatment of anal fistula. In several studies, this method has been shown to be safe and effective, with reported success rates ranging from 40 to 88%. We hypothesized that with longer follow-up, these rates would decrease. METHODS: A retrospective case analysis assessing the effectiveness of laser fistulectomy in curing fistula-in-ano tracts within a cohort of patients at a single academic institution was conducted. All patients having laser ablation between March 2016 and July 2018 were analyzed. Cure of the fistula was determined by history and postoperative physical exam, and was defined as complete closure of fistula tract with resolution of symptoms. Secondary symptoms of fecal incontinence, infection, and pain were evaluated. RESULTS: Eighteen patients (10 males, mean age 41 ± 13 years) were analyzed. Transphincteric fistula was the most common type (67%, N = 12). The mean number of previous fistula procedures was 1.33 ± 1.64. There was a 22% (N = 4) success rate at an average postoperative follow-up period of 29 ± 8 months (range 18-46 months). Of those who failed, 64% (N = 9) had a subsequent fistula procedure. There were no cases of fecal incontinence, but 3 cases (17%) of postoperative infection were reported and 8 patients (44%) had a subjective increase in pain at first follow-up appointment. CONCLUSIONS: Our data showed a much higher failure rate of laser fistulectomy compared to those reported in the literature. However, the small sample size, a large amount of heterogeneity in our patient population with a mixture of fistula types present, and various laser techniques applied decreased the power of this study.

A systematic review and meta-analysis of the safety and efficacy of fistula laser closure.

BACKGROUND: Fistula laser closure (FiLaC) is a novel sphincter-saving technique for the treatment of fistula-in-ano. The aim of this study was to assess the safety and efficacy of the FiLaC procedure. METHODS: Databases including PubMed/Medline, Scopus, Web of Science, and Embase were searched for articles assessing FiLaC. All studies including case series and comparative studies reporting the outcome of FiLaC in the treatment of fistula-in-ano were considered eligible. The main outcomes were healing rates of fistula laser closure, postoperative complications including incontinence, technical aspects of the procedure and failure of healing. RESULTS: Seven studies were included. There were a total of 454 patients, 69.1% with a transsphincteric fistula-in-ano and 35% with recurrent disease. The median age of the patients was 43 years (range 18-83 years). The median operation time was 18.3 min (range 6-32 min). With a median follow-up of 23.7 months, the weighed mean rate of primary healing was 67.3% and the overall success when FiLaC was reused was 69.7%. The weighted mean rate of complications was 4%, all of them were minor complications and the weighted mean rate of continence affection was 1% in the form of minor soiling. CONCLUSIONS: FiLaC may be considered an effective and safe sphincter-saving technique for the treatment of fistula-in-ano with an acceptable, low, complication rate. However, well-designed randomized control trials comparing FiLaC with other techniques are required to substantiate the promising outcomes reported in this review.

Implementation of laser ablation of fistula tract (LAFT) for perianal fistulas: do the results warrant continued application of this technique?

BACKGROUND: Laser Ablation of Fistula Tract (LAFT) is a novel technique for the treatment of perianal fistulas. Initial reports have shown moderate-to-good results. The aim of this study was to evaluate this implementation and the effectiveness of this technique. Patients were offered LAFT as a treatment option for their perianal fistulas at the outpatient clinic between November 2016 and April 2018. Inclusion criteria were intersphincteric and transsphincteric fistula of cryptoglandular origin [10]. Exclusion criteria were supra- or extrasphincteric fistula, Crohn's disease, presence of undrained collections or side tracts and malignancy-related fistula. The primary outcome was fistula healing rate, the main secondary outcome incidence of postoperative fecal incontinence. Healing and postoperative FISI were evaluated at our outpatient clinic during follow-up at 6 and 12 weeks. A questionnaire was sent to all patients to evaluate the long-term postoperative FISI and patient satisfaction after 3 months. RESULTS: Between November 2016 and April 2018, 20 patients [m:f = 4:16, median age 45 (27-78) years] underwent LAFT. Median follow-up was 10 months (IQR 7.3 months). A draining seton was placed in 15 (75%) of all patients with a median time of 12 weeks (IQR 14 weeks) prior to LAFT. Five intersphincteric and 13 transsphincteric fistulas were treated. Overall healing rate was 20% (4/20). The median postoperative fecal incontinence severity index (FISI) score was 0 (range 0-38); however, we found a change in continence in 39% of the patients. CONCLUSIONS: LAFT has now been discontinued as a treatment of cryptoglandular perianal fistulas in our centre, because of its disappointing results. Further detailed research seems to be warranted to investigate its exact indication and limitations.

The optimal indication for FiLaC® is high trans-sphincteric fistula-in-ano: a prospective cohort of 69 consecutive patients.

BACKGROUND: The aim of our study was to prospectively evaluate the effectiveness of the Fistula Laser Closure (FiLaC®) technique in patients at high risk of anal incontinence and to determine the predictors of success and the impact of the procedure on anal continence. METHODS: A prospective study was conducted on all patients treated with FiLaC® in our department in May 2016-April 2017, because they were at high risk of anal incontinence after fistulotomy, The fistula was considered healed when the internal and external openings were closed and the patient experienced was no pain or leakage. RESULTS: A total of 69 consecutive patients (34 males) with a median age of 40 years (33-53 years) were included in the study. One patient was lost to follow up. The fistulas were intersphincteric (3%), low (15%) or high (66%) trans-sphincteric, and suprasphincteric (16%). After a median follow-up period of 6.3 months (4.2-9.3), fistula healing was observed in 31 patients (45.6%). In univariate analysis, high trans-sphincteric fistulas (p = 0.007) and age over 50 years (p = 0.034) were significantly associated with healing. In multivariate analysis, only high trans-sphincteric fistulas were a predictive factor of significant success. No new cases of anal incontinence or any worsening in case of pre-existing anal incontinence were observed during follow-up. CONCLUSIONS: FiLaC® is particularly effective in cases of high trans-sphincteric fistulas (60% cure). This technique seems to be the most promising sphincter-saving technique available for this indication.

A systematic review of new treatments for cryptoglandular fistula in ano.

AIM: In 2007 the ACPGBI published a position statement on the management of cryptoglandular fistula in ano. Over the last seven years a number of new treatments have been developed and the aim of this systematic review was to assess their effectiveness. METHOD: A systematic review of all English language literature relevant to novel treatment strategies for cryptoglandular fistula in ano, published between 1 January 2007 and 31 Dec 2014 was carried out using MEDLINE (PubMed and Ovid), EMBASE (Ovid) and the Cochrane Library of Systematic Reviews/Controlled Trials for relevant literature. Technical notes, commentaries, letters and meeting abstracts were excluded. The different treatments were assessed with regards to fistula closure rate in relation to length of follow up and reported complications. RESULTS: Seventy potential articles published between 1 January 2007 and 31 December 2014 were identified from the initial literature search. Twenty-one articles were included for final analysis although only two were randomized controlled trials, the remainder being retrospective or prospective series. CONCLUSION: This systematic review has demonstrated that whilst there have been technological advances to treat complex cryptoglandular fistula in ano, these are in an early stage of evolution and although early results were promising they are difficult to reproduce. Longer follow up data is not currently available and these treatments should not be introduced without further evidence.

Five years of experience with the FiLaC™ laser for fistula-in-ano management: long-term follow-up from a single institution.

BACKGROUND: There are limited data available concerning endofistular therapies for fistula-in-ano, with our group reporting the first preliminary outcomes of the use of the radial fibre Fistula laser Closing (FiLaC ™) device. METHODS: The aim of this study was to assess a cohort of anal fistulae managed with laser ablation plus definitive flap closure of the internal fistula opening over a long-term follow-up. Factors governing primary healing success and secondary healing success (i.e. success after one or two operations) were determined. RESULTS: The study analysed 117 patients over a median follow-up period of 25.4 months (range 6-60 months) with 13 patients (11.1%) having Crohn's-related fistulae. No incontinence to solid and liquid stool was reported. Minor incontinence to mucus and gas was observed in two cases (1.7%), and a late abscess treated in one case (0.8%). The primary healing rate was 75/117 (64.1%) overall, and 63.5% for cryptoglandular fistulae versus 69.2% for Crohn's fistulae, respectively. Of the 42 patients who failed FiLaC™ 31 underwent a second operation ("Re-FiLaC™", fistulectomy with sphincter reconstruction or fistulotomy). The secondary healing rate, defined as healing of the fistula at the end of the study period, was 103/117 (88.0%) overall and 85.5% for cryptoglandular fistulae versus 92.3% for Crohn's fistulae. A significantly higher primary success rate was observed for intersphincteric-type fistulae with primary and secondary outcome unaffected by age, gender, presence of Crohn's disease, number of prior surgeries and the type of flap designed to close the internal fistula opening. CONCLUSIONS: There is a moderate primary success rate using first-up FiLaC™ treatment. If FiLaC™ fails, secondary success with repeat FiLaC™ or other approaches was high. The minimally invasive FiLaC™ approach may therefore represent a sensible first-line treatment option for anal fistula repair.

Closure of fistula-in-ano with laser--FiLaC™: an effective novel sphincter-saving procedure for complex disease.

AIM: Fistula laser closure (FiLaC™) is a novel sphincter-saving procedure for the treatment of anal fistula. Primary closure of the track is achieved using laser energy emitted by a radial fibre connected to a diode laser. The energy causes shrinkage of the tissue around the radial fibre with the aim being to close the track. This pilot study was designed to investigate the safety and effectiveness of this new technique in the treatment of anal fistula. METHOD: Thirty-five patients with anal fistula underwent the FiLaC™ procedure. They had either a primary or a recurrent trans-sphincteric anal fistula, a previously placed seton or a fistula involving a significant portion of the sphincter with a potential risk of postoperative incontinence on fistulotomy. The surgical procedure consisted of 'sealing' the fistula by laser energy. The primary end-point was cure of the disease and evaluation of morbidity. The secondary end-point was an assessment of the degree of postoperative continence using the Cleveland Clinic Florida (CCF) Fecal Incontinence Score. RESULTS: The median operation time was 20 (6-35) min. No intra-operative complications were reported. Median duration of follow up was 20 (3-36) months. Primary healing was observed in 25 (71.4%) patients. There were eight (23%) failures and two recurrences at 3 and 6 months after the operation. No patient reported incontinence postoperatively. CONCLUSION: The laser FiLaC™ procedure for fistula-in-ano is a safe, relatively simple, minimally invasive, sphincter-saving procedure with a high chance of success.

Laser technology in proctological diseases: is it really the wave of the future?

Different types of lasers have been applied for various proctological conditions. We discuss about published articles regarding the application of lasers, with concern about evidence-based use of these techniques and technologies. We performed a literature search about laser treatments for proctological conditions. 55 studies were included for the final revision. Meta-analysis of data was not performed because of heterogeneity of study designs and outcome measures. A scoping review was performed. Laser treatments for hemorrhoids require a shorter operative time and show less postoperative pain and bleeding compared to conventional hemorrhoidectomy, but are more expensive. Studies are heterogeneous in design, endpoints, postoperative assessment, length of follow-up and outcome measures. Only 3 RCTs are available and only three studies evaluate long-term outcomes. FiLaC (fistula laser closure) was initially described in 2011 for the treatment of anal fistula. In the published studies the reported healing rates vary between 20 and 82%, and the ideal indication is yet to be defined. Studies with long-term follow-up are lacking. SiLaT (sinus laser treatment) applied the technology used for FiLaC to the treatment of pilonidal sinus disease. This technique had less perioperative pain and shorter hospital stay, but a lower primary healing rate when compared to traditional techniques. Available data is very limited, and no randomized trials are published to date. Laser assisted techniques are a viable, minimally invasive, but expensive option for the treatment of several proctological conditions. Further researches are needed to assess if patients could benefit of their use, and for what indication.

Closure of Fistula-in-Ano Using a Radial-Emitting Laser Probe: Initial Experience in Lagos, Nigeria.

Background: Fistula-in-ano treatment has remained quite challenging with high failure rates and a potential for damage to the anal sphincteric complex leading to flatal or faecal incontinence. The treatment of fistula-in-ano using the fistula laser closure (FiLaC) as a minimally invasive, sphincter-saving procedure for complex disease has recently been documented. Objectives: This review aimed to report the outcome of using it at the Lagos University Teaching Hospital. Patients and Methods: The procedures were performed with a radially emitting laser fibre from Biolitec AG-CeramOptec (Bonn, Germany). The duration of symptoms, type of fistula, duration of the procedures, and postoperative complications were evaluated. Results: Eleven male patients had laser fistula-in-ano closure. The age range was 33-51 years, with a median age of 39 years and an interquartile range (IQR) of 37-47 years. Five patients were noted to have high fistula/e, whereas six had low fistula/e, seven had a single tract each, and three had three tracts each. The duration of surgery ranged, approximately from 3 to 60 min, with a median of 19 min and IQR of 9-33 min. Postoperative pain was mild in all patients and were all discharged as day case. There was no postoperative wound infection, anal incontinence, anal stenosis, and subcutaneous abscess. However, there was a recurrence in two patients. Conclusions: FiLaC has been demonstrated to be a reliable and safe sphincter-saving procedure for treating fistula-in-ano even for complex and high fistulae that is feasible in our subregion.

Case report: Complex perianal fistula treated with fistula laser closure (FILAC) and suction catheter.

INTRODUCTION AND IMPORTANCE: A patient presented with complex perianal fistula treated with fistula laser closure (FILAC) combined with suction catheters. CASE PRESENTATION: Male, 29 years old, presented in our department, presented with complex perianal fistula with a history of fistulectomy and tight seton for 6 months in another health facility. Intraoperative findings were a tract of 4,5 cm long, 4 external openings, and 1 internal opening. Definitive treatment of Fistula Laser Closure (FILAC) with 13-watt power laser diode produces by BIOLITEC German. CONCLUSION: The patient recovers within 6 months. Promising results have been shown by combining FILAC and suction catheter for complex perianal fistula.

Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes.

Fistula laser closure (FiLaC) is a relatively new sphincter-sparing technique in fistula surgery that was initially reported in 2011. It involves the radial dissipation of laser energy in the fistula tract and, through a combination of coagulation and shrinkage of the tract, is proposed to result in progressive sealing of fistulas. Early studies have suggested minimal impact on continence and touted the advantage of minimal morbidity with potential of repeat procedures if the technique fails initially. Despite early promising results, ten years on, questions remain on the technique, patient selection and long-term outcomes. This narrative review assesses the evidence reported to-date of radially emitting laser fistula surgery in the treatment of perianal fistulas.

Late rectal anastomotic leakage treated with diode laser FiLaC probe. A case report of a new minimal invasive treatment.

INTRODUCTION: Anastomotic Leakage (AL) is one of the most important early postoperative complication of the adenocarcinoma's surgical treatment. Fistula Laser Closure (FiLaC®) is a minimal invasive technique that use diode laser energy to obtain the fistula track obliteration and it is finding large application for other affection characterized by fistula tracts presence. PRESENTATION OF CASE: A 56 years old male, with no clinical history of adenocarcinoma in his family, underwent a laparoscopic low anterior resection with ileostomy for a rectal adenocarcinoma. Approximately 3 months after the procedure an anastomotic leak with an associated abscess was found. The patient underwent an endoscopic FiLaC off-label procedure on the AL and after further 4 months, he obtained a complete resolution of the anastomosis dehiscence. DISCUSSION: The literature is poor about the minimal invasive AL treatment and there is no paper about the management of the AL with the FiLaC® procedure. For asymptomatic patients a conservative solution is preferred, it could be considered a drain positioning for emptying abscesses and for irrigation or the use of an Endosponge to decrease the resolution time. The FiLaC® procedure could be a more feasible technique that could also reduce the healing time as well with no discomfort for the patient. CONCLUSION: Considering the results and our patient healing time, we think that an off-label application of FiLaC® procedure on asymptomatic low anastomotic leak could be an opportunity for a morbidity resolution shorter than the simple wait and see strategy, and more sustainable for the patient.

FiLaC procedure for highly selected anal fistula patients: indications,safety and efficacy from an observational study at a tertiary referral center / Procedimiento FiLaC para pacientes con fístula anal altamente seleccionados: indicaciones, seguridad y eficacia de un estudio observacional en un centro de referencia terciario

Background: the ideal clinical profile of patients or fistula features for fistula laser closure (FiLaC®) technique remain to be established. The aim of this study was to analyze clinical outcomes and the safety profile of FiLaC® in search for an ideal setting for this technique. Methods: a retrospective observational study was performed from a prospective database including all consecutive patients who underwent surgery for anal fistula (AF) with FiLaC® in the coloproctology unit of a tertiary referral center, between October 2015 and December 2021. The FiLaC® procedure was offered to AF patients who were considered to be at risk of fecal incontinence. Fistulas were described according to Parks’ classification and categorized as complex or simple according to the American Gastroenterological Association (AGA) guidelines. Healing was defined by the closure of the internal and external openings for at least six months. Predictive factors of AF healing were investigated. Results: a total of 36 patients were included, with a mean age of 48 ± 13.9 years. Twenty patients (55.6 %) were male and 13 patients (36 %) had Crohn’s disease (CD). Fourteen patients (38.8 %) had a complex fistula. The primary and secondary healing rates were 55.6 % and 91.7 %, respectively, during a median follow-up time of 12 months (IQR 7-29). No fecal continence impairment was registered in any case. The proportion of patients with primary healing was significantly higher in CD patients (76.9 % vs 43.5 %, p = 0.048). Conclusions: FiLaC® is a sphincter-preserving procedure with an excellent safety profile and reasonable success rate despite of the strict patient selection. This technique may be attractive for patients with CD due to its higher primary healing rate.(AU)