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.

What are the outcomes in patients referred to a tertiary referral centre for Crohn's rectovaginal fistula surgery?

AIM: Rectovaginal fistulas in patients with Crohn's disease are challenging to manage, and surgical treatment remains the best option for achieving permanent closure of the fistula. Biologicals are now used routinely for patients with Crohn's disease. The aim of this study was to investigate the surgical procedures used by us to treat rectovaginal fistula in patients with Crohn's disease in the era of biologicals. METHOD: Patients with Crohn's disease who underwent surgery for a rectovaginal fistula between 2010 and 2020 were included in this retrospective study and were identified from a prospectively maintained institutional database. Collected variables included demographics, perioperative and operative variables and data regarding medications used. Success of the procedure was defined as no symptoms at least 6 months after definitive repair and/or stoma closure. RESULTS: Twenty patients (out of 80 referred for evaluation) underwent surgery with intent to close the fistula and had at least 6 months of follow-up. Mean age was 44 ± 12 years with a median follow-up duration of 33 months (range 6-130 months). Forty per cent of the patients had a history of at least two surgeries to close the fistula. The overall healing rate was 70% (14/20). The most performed procedure was a transanal rectal advancement flap (7/20), with a success rate of 85%. CONCLUSION: Rectovaginal fistula in Crohn's disease is difficult to cure; according to our results almost half of these patients have multiple surgeries due to recurrence. Multiple procedures may be offered for this challenging problem in motivated patients. Perioperative diversion should be strongly considered.

Healing of rectal advancement flaps for anal fistulas in patients with and without Crohn's disease: a retrospective cohort analysis.

BACKGROUND: Surgical closure of anal fistulas with rectal advancement flaps is an established standard method, but it has a high degree of healing failure in some cases. The aim of this study was to identify risk factors for anal fistula healing failure after advancement flap placement between patients with cryptoglandular fistulas and patients with Crohn's disease (CD). METHODS: From January 2010 to October 2020, 155 rectal advancement flaps (CD patients = 55, non-CD patients = 100) were performed. Patients were entered into a prospective database, and healing rates were retrospectively analysed. RESULTS: The median follow-up period was 189 days (95% CI: 109-269). The overall complication rate was 5.8%. The total healing rate for all rectal advancement flaps was 56%. CD patients were younger (33 vs. 43 years, p < 0.001), more often female (76% vs. 30%, p < 0.001), were administered more immunosuppressant medication (65% vs. 5%, p < 0.001), and had more rectovaginal fistulas (29% vs. 8%, p = 0.001) and more protective stomas (49% vs. 2%, p < 0.001) than patients without CD. However, no difference in healing rate was noted between patients with or without CD (47% vs. 60%, p = 0.088). CONCLUSIONS: Patients with anal fistulas with and without Crohn's disease exhibit the same healing rate. Although patients with CD display different patient-specific characteristics, no independent factors for the occurrence of anal fistula healing failure could be determined. Trial registration Not applicable due to the retrospective study design.

Long-term functional and clinical outcomes following transanal advancement flap for complex anal fistula repair: are there predictors of recurrence and incontinence?

AIM: Transanal flap is an attractive technique for complex fistulas. The aim of this study was to identify factors associated with poor outcome, recurrence and incontinence. METHOD: All patients who underwent an advancement flap for the treatment of a complex anal fistula between 1995 and 2019 were prospectively enrolled. The patient data obtained included age, sex, body mass index, comorbid conditions and smoking history. The fistula characteristics analysed included previous anal surgery, anatomy of the fistula according to Park's classification, horseshoe or supralevator extension and preoperative seton drainage. The postoperative data registered included complications, postoperative stay, recurrence and incontinence. Predictive factors for recurrence and incontinence were identified using univariate and multivariate analysis. RESULTS: One hundred and ninety patients were included; 134 (70.5%) were men and the mean patient age was 50 years. The median length of follow-up was 44.6 months. The fistula recurred in 14 patients (7.3%). Before surgery, 20 patients (10.5%) reported incontinence symptoms. In the continent patients a Wexner postoperative score of 0 was identified in 79.4%. Wexner scores between 1 and 3 were observed in 17% and scores of 4 or more in five patients (3%). Factors associated with recurrence included age < 50 years (OR = 4.8, P = 0.02, 95% CI 1.2-19), smoking (OR = 4.1, P = 0.03, 95% CI 1-16.5) and suprasphincteric fistula (OR = 0.5, P = 0.01, 95% CI 0.2-0.8) in multivariate log regression analysis. Major incontinence was influenced by female sex and previous anal surgery (OR = 7.5, P = 0.003, 95% CI 1.6-34 and OR = 0.1, P = 0.007, 95% CI 0.1-0.7, respectively). CONCLUSION: Full-thickness transanal advancement flap is a good treatment for complex anal fistula repair. This study provides relevant information on risk factors for failure of therapy and incontinence, which can help in advising patients before surgery and planning a good treatment strategy.

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

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

Treatment Strategies in Crohn's-Associated Rectovaginal Fistula.

Rectovaginal fistula (RVF) is a rare, but dreaded complication of Crohn's disease (CD) that is exceedingly difficult to manage. Treatment algorithms range from observation and medical therapy to local surgical repair and proctectomy. The multitude of surgical options and lack of consensus between experts speak to the complexity and shortcomings encountered to correct this disease process surgically. The key to successful management of these fistulae therefore rests on a multidisciplinary approach between the patient, gastroenterologists, and surgeons, with open communication about expectations and goals of care. In this article, we review the management of CD-associated RVF with an emphasis on surgical technique.

Comparison of porcine collagen paste injection and rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a 2-year follow-up study.

BACKGROUND: Rectal advancement flap is the standard surgical treatment for complex cryptoglandular anal fistulas, while Permacol™ collagen paste is considered an innovative treatment option for anorectal fistulas. This study aimed to compare the clinical outcomes of patients with complex cryptoglandular fistulas treated by endorectal advancement flap versus Permacol™ paste. METHODS: This study was a retrospective analysis of patients with complex cryptoglandular anal fistulas. Thirty-one patients were treated with the rectal advancement flap (RAF group), while 21 were treated with Permacol™ paste injection (PP group). In PP group, the approach consisted of loose seton positioning followed several weeks later by closure internal opening with a resorbable sutures associated with paste injection into the fistula track. Clinical outcomes were assessed in terms of healing rate, faecal continence and patient satisfaction. RESULTS: Seton drainage was done in all patients in both groups for a median duration of 8 weeks (range 4-18 weeks) before the final surgery (p = 0.719). No patient had faecal incontinence (CGS ≥ 5) preoperatively. Five patients (16%) in the RAF group and one (5%) in the PP group experienced faecal incontinence postoperatively. The 2-year disease-free survival was 65% in the RAF group and 52% in the PP group (p = 0.659). The median satisfaction scores were 5 (range 1-10) in the RAF group and 7 (range 2-10) in the PP group (p = 0.299). CONCLUSION: The RAF appeared superior to PP in terms of fistula healing, although this result was not statistically significant. On the contrary, PP has a potential advantage in terms of continence disorders. Permacol™ paste can be considered as the initial treatment option for complex cryptoglandular anal fistulas in patients with faecal continence disorders.

A comparative study on the effectiveness of rectal advancement flap and seton placement surgeries in patients with anal fistula on the rate of recurrence, incontinence and infection.

INTRODUCTION: Due to the high prevalence of anal fistulas and the recurrence of the disease following surgery, different methods have been suggested for appropriate treatment of this disease. In this study, the effects of rectal advancement flap surgery and seton placement on the recurrence rate, incontinence and wound infection were compared. METHODS: In this interventional, prospective and quasi-experimental study, 45 patients with anal fistulas including 28 males and 17 females were studied for 2 years (2015-2017). Patients were divided into two groups and mucosal advancement flap and seton placement techniques were used for each of them. Descriptive analysis of data was performed by SPSS software. RESULTS: 24 patients (54%) had seton placement surgery and 21 patients (46%) underwent rectal advancement flap surgery. Recurrence was significantly higher in patients who underwent seton placement surgery than the group that underwent rectal advancement flap surgery. Twelve patients (57%) who underwent rectal advancement flap surgery showed improvement in sphincter tone while 11 patients (45%) showed improvements with seton placement. CONCLUSION: The overall results of this study showed that rectal advancement flap surgery reduces recurrence and wound infection more significantly than seton placement in patients with anal fistula.

The changes in resting anal pressure after performing full-thickness rectal advancement flaps.

BACKGROUND: Advancement flap is an accepted approach for treating complex fistula-in-ano.The purpose was to evaluate the changes in resting pressure along the anal canal after performing a full-thickness flap. METHODS: Manometric review of patients who have undergone a full-thickness rectal advancement flap procedure for complex anal fistulas of cryptoglandular origin. Recurrence and continence were evaluated. Resting Anal Pressure was assessed along the anal canal by two measures: maximum resting pressure(MRP) and inferior resting pressure(IRP) at 0.5 cm from the anal verge. RESULTS: 119 patients were evaluated. Overall recurrence rate was5.9%. Anal continence was maintained intact in 76.5%. Manometric study showed a significant decrease in postoperative MRP(90.6 ± 31.9 to 45.2 ± 20 mmHg; p < 0.001), while IRP values did not differ significantly(28.2 ± 18.3 to 23.2 ± 13.5 mmHg; p = 0.1). CONCLUSIONS: Performing a full-thickness rectal flap causes a decrease of the MRP in the middle third of the anal canal, due to the inclusion of the internal sphincter in flap. It seems crucial to preserve the distal internal sphincter intact as it helps both to maintain the resting pressure in the lower third and avoid deformities of the anal margin.