Ustekinumab for Perianal Crohn's Disease: The BioLAP Multicenter Study From the GETAID.

INTRODUCTION: New therapeutic options for patients with Crohn's disease (CD) with perianal lesions failing anti-tumor necrosis factor (TNF) agents are needed. We aimed to assess the effectiveness of ustekinumab in perianal CD (pCD) and predictors of clinical success in a real-life multicenter cohort. METHODS: We conducted a national multicenter retrospective cohort study in patients with either active or inactive pCD who received ustekinumab. In patients with active pCD at treatment initiation, the success of ustekinumab was defined by clinical success at 6 months assessed by the physician's judgment without additional medical or surgical treatment for pCD. Univariate and multivariable logistic regression analyses were performed to identify predictors of success. In patients with inactive pCD at ustekinumab initiation, the pCD recurrence-free survival was calculated using the Kaplan-Meier method. RESULTS: Two hundred seven patients were included, the mean age was 37.7 years, the mean duration of CD was 14.3 years, and the mean number of prior perianal surgeries was 2.8. Two hundred five (99%) patients had previously been exposed to at least 1 anti-TNF and 58 (28%) to vedolizumab. The median follow-up time was 48 weeks; 56/207 (27%) patients discontinued therapy after a median time of 43 weeks. In patients with active pCD, success was reached in 57/148 (38.5%) patients. Among patients with setons at initiation, 29/88 (33%) had a successful removal. The absence of optimization was associated with treatment success (P = 0.044, odds ratio 2.74; 95% confidence interval: 0.96-7.82). In multivariable analysis, the number of prior anti-TNF agents (≥3) was borderline significant (P = 0.056, odds ratio 0.4; 95% confidence interval: 0.15-1.08). In patients with inactive pCD at initiation, the probability of recurrence-free survival was 86.2% and 75.1% at weeks 26 and 52, respectively. DISCUSSION: Ustekinumab appears as a potential effective therapeutic option in perianal refractory CD. Further prospective studies are warranted.

Impacto en la calidad de vida del tratamiento del cáncer de próstata organoconfinado / Impact of organ confined prostate cancer treatment on quality of life

INTRODUCCIÓN: El cáncer de próstata (CP) es el segundo cáncer más frecuente del mundo y en los varones. Se estima que la incidencia crezca a 1,7 millones de casos nuevos y 499.000 nuevas muertes en 2030. El tratamiento del cáncer de próstata organoconfinado (CPOC) puede afectar a un individuo tanto física como mentalmente, así como sus relaciones cercanas y su trabajo o vocación, lo cual condiciona la calidad de vida (CV) relacionada con la salud. OBJETIVO: Conocer el impacto en la CV atribuible al tratamiento del CPOC. MATERIALES Y MÉTODOS: Es un estudio observacional multicéntrico de carácter prospectivo de 406 pacientes con CPOC tratados desde enero del año 2015 hasta junio del 2018. La muestra se dividió en cuatro grupos de estudio (GA, GB, GC y GD), correspondientes a los distintos métodos de abordaje quirúrgico: prostatectomía radical (PR), radioterapia externa (RTE), braquiterapia (BT) y diferente a monoterapia con alguno de los otros, respectivamente. RESULTADOS: La edad en el GC fue inferior, la media del antígeno prostático específico (PSA, prostatic specific antigen) de todos los pacientes fue 8,13 ng/ml, el grupo de mayor media de PSA fue el GB con 10,43 ng/dL, la media del estadio tumoral (TNM,) fue 3,82, la CV postratamiento en GD fue inferior respecto a los demás grupos. CONCLUSIÓN: El tratamiento del CPOC afecta la CV La monoterapia curativa, concretamente la PR y la BT, afectan menos a la CV que la radioterapia externa u otras alternativas terapéuticas. La incontinencia urinaria y las fístulas secundarias al tratamiento del CPOC son las que producen más deterioro en la CV. El cuestionario SF 36 validado internacionalmente es una medida transversal de la CV, útil para comparar el impacto de los tratamientos del CPOC

INTRODUCTION: Prostate cancer (PCa) is the second most common male cancer in the world. Its incidence is estimated to grow to 1.7 million new cases and 499,000 new deaths by 2030. Treatment of OCPC can affect patients physically and mentally, as well as their close relationships and their job or career, which conditions health-related quality of life (QoL). OBJECTIVE: Evaluate the impact on QoL attributable to the treatment for Organ Confined Prostate Cancer (OCPC). MATERIALS AND METHODS: Prospective multicenter observational study of 406 patients with OCPC treated from January 2015 to June 2018. The sample was divided into four study groups, according to the type of treatment: radical prostatectomy (RP) (GA), external radiotherapy (ERT) (GB), brachytherapy (BT) (GC) and other treatments different from monotherapy with RP, ERT or BT (GD). RESULTS: The age in GC was lower, the mean Prostate Specific Antigen (PSA) of all patients was 8.13 ng/ml, the group with the highest mean PSA was GB with a mean of 10.43 ng/dL, the mean Tumor Stage (TNM) was 3.82, and GD had the lowest post treatment quality of life. CONCLUSION: OCPC treatment affects QoL. Curative monotherapies, specifically RP and BT, have less effect on QoL than external radiotherapy or other therapeutic alternatives. Urinary incontinence and fistulas secondary to OCPC have the highest impact on QOL impairment. The internationally validated SF 36 questionnaire is a useful cross-sectional measure of QOL to compare the impact of OCPC treatment modalities

Video-Assisted Ligation of Intersphincteric Fistula Tract for Complex Anal Fistula: Technique and Preliminary Outcomes.

BACKGROUND: Sphincter-preserving operations have been increasingly used for treating anal fistula. However, their success rates remain modest in complex anal fistulas. OBJECTIVE: This study aimed to report outcomes of video-assisted ligation of intersphincteric fistula tract (a procedure combining video-assisted anal fistula treatment and ligation of intersphincteric fistula tract) for treating complex anal fistulas and to compare its results with conventional ligation of intersphincteric fistula tract. DESIGN: A review of prospectively collected data from October 2014 to December 2017 was performed. SETTINGS: The study was conducted at a large tertiary hospital in Thailand. PATIENTS: All patients with primary or recurrent complex anal fistulas undergoing video-assisted ligation of intersphincteric fistula tract were included. Patients with anal fistula related to malignancy, Crohn's disease, tuberculosis, or acute abscess were excluded. MAIN OUTCOME MEASURES: Healing as defined by an absence of fistula or drainage from an external opening and complete epithelialization of the external opening were measured. RESULTS: This study included 103 patients with a median age of 47 years. The primary healing rate was 84.5% at a median follow-up of 28 months (range, 15-38 mo). Primary healing rates of anterior high transsphincteric fistula, semi-horseshoe fistula, and horseshoe fistula were 88% (44 of 50 cases), 77% (30 of 39 cases), and 93% (13 of 14 cases). Median time to healing was 4 weeks (range, 4-8 wk). Accordingly, the overall failure rate was 15.5%. None reported worse fecal incontinence postoperatively. Video-assisted ligation of intersphincteric fistula tract had a higher rate of primary healing for complex anal fistula than ligation of intersphincteric fistula tract (84.5% vs 63.4%; p < 0.001). LIMITATIONS: This study is limited by its small sample size. CONCLUSIONS: The outcomes of video-assisted ligation of intersphincteric fistula tract for complex anal fistulas are quite good. This technique has the potential to become another viable option of sphincter-preserving operation for complex anal fistulas. See Video Abstract at http://links.lww.com/DCR/B373. LIGADURA ASISTIDA POR VIDEO DEL TRACTO DE LA FÍSTULA INTERESFINTÉRICA PARA LA FÍSTULA ANAL COMPLEJA: TÉCNICA Y RESULTADOS PRELIMINARIES: Las operaciones de preservación del esfínter se han utilizado cada vez más para tratar la fístula anal. Sin embargo, sus tasas de éxito siguen siendo modestas en las fístulas anales complejas.Este estudio tuvo como objetivo informar los resultados de la ligadura asistida por video del tracto de la fístula interesfintérica (un procedimiento que combina el tratamiento de la fístula anal asistida por video y la ligadura del tracto de la fístula interesfintérica) para el tratamiento de las fístulas anales complejas y comparar sus resultados con la ligadura convencional de la fístula interesfintérica tracto.Se realizó una revisión de los datos recolectados prospectivamente desde Octubre de 2014 hasta Diciembre de 2017.El estudio se realizó en un gran hospital terciario en Tailandia.Se incluyeron todos los pacientes con fístulas anales complejas primarias o recurrentes sometidas a ligadura asistida por video del tracto de la fístula interesfintérica. Se excluyeron los pacientes con fístula anal relacionada con malignidad, enfermedad de Crohn, tuberculosis o absceso agudo.Curación definida por la ausencia de fístula o drenaje de la abertura externa y la epitelización completa de la abertura externa.Este estudio incluyó 103 pacientes con una mediana de edad de 47 años. La tasa de curación primaria fue del 84,5% con una mediana de seguimiento de 28 meses (rango 15-38). La tasa de curación primaria de la fístula transesfintérica alta anterior, la fístula semi-herradura y la fístula de herradura fue del 88% (44 de 50 casos), 77% (30 de 39 casos) y 93% (13 de 14 casos), respectivamente. El tiempo mediano hasta la curación fue de 4 semanas (rango 4-8). En consecuencia, la tasa de fracaso general fue del 15,5%. Ninguno informó peor incontinencia fecal después de la operación. La ligadura asistida por video del tracto de la fístula interesfintérica tuvo una mayor tasa de curación primaria para la fístula anal compleja que la ligadura del tracto de la fístula interesfintérica (84.5% vs 63.4%; p <0.001).Este estudio está limitado por su pequeño tamaño de muestra.Los resultados de la ligadura asistida por video del tracto de la fístula interesfintérica para fístulas anales complejas son bastante buenos. Esta técnica tiene el potencial de convertirse en otra opción viable de operación de preservación del esfínter para fístulas anales complejas. Consulte Video Resumen en http://links.lww.com/DCR/B373. (Traducción-Dr Yesenia Rojas-Khalil).

Infliximab for Crohn's Disease Patients with Perianal Fistulas: Better Image, Better Life.

BACKGROUND Patients with Crohn's disease (CD) experience physical impairments, poor quality of life and negative body image. These factors are exacerbated in CD patients with active perianal fistulas. MATERIAL AND METHODS Baseline characteristics were compared in retrospectively enrolled CD patients with and without active perianal fistulas. The relationships between improvements in perianal fistulas and quality of life, body image, and self-esteem were determined. The effects of infliximab treatment on improvement of psychological-social status were assessed in CD patients with active perianal fistulas. RESULTS Of the 301 CD patients included in our institution's database. 91 (30.2%) had active perianal fistulas. After adjustment by propensity score matching, CD patients with active perianal fistulas had lower self-esteem and more severe body image dissatisfaction than CD patients without active perianal fistulas (P<0.01 each). Perianal fistula response was closely associated with improvements in quality of life, body image dissatisfaction and self-esteem (P<0.01 each). Patients with perianal fistula treated with infliximab showed a response rate of 68.3%, significantly higher than the rate in patients with perianal fistula not treated with infliximab (P=0.005). Furthermore, improvements of life quality, body image and self-esteem were significantly greater in patients with perianal fistula who were than were not treated with infliximab (P<0.05 each). CONCLUSIONS CD patients with active perianal fistulas experience body image dissatisfaction, low self-esteem and poor quality of life. Treatment of these patients with infliximab could improve their body image, self-esteem and quality of life.

Darvadstrocel for the treatment of perianal fistulas in Crohn's disease.

INTRODUCTION: Perianal fistulizing Crohn's disease is associated with a poor quality of life and current medical and surgical treatment options are limited. Darvadstrocel, composed of mesenchymal stem (stromal) cells (MSC), has recently been approved by the European Medicines Agency (EMA) for the treatment for perianal disease. This drug profile educates the reader with this novel treatment approach. AREAS COVERED: A literature search was performed on PubMed with focus on perianal fistulizing Crohn's disease and mesenchymal stem (stromal) cells. This review summarizes evidence of the current standard of care and discusses the mechanism of action, manufacturing, and application and safety of darvadstrocel. EXPERT OPINION: Darvadstrocel is a safe and effective therapy for complex perianal fistulizing Crohn's disease.

Lift and VAAFT for high trans-sphincteric anal fistula: a single center retrospective analysis.

PURPOSE: The management of complex anal fistulas remains a challenge, mainly due to the considerable risk of incontinence. We compared LIFT and VAAFT in the treatment of complex anal fistulas in terms of healing time, recurrence, continence, morbidity, and postoperative pain, focusing also on patients with local abscess at the time of surgery. METHODS: We include all patients with high trans-sphincteric anal fistula even with abscess at the time of surgery. Anorectal manometry, endoanal ultrasound, Cleveland Clinic fecal incontinence score, VAS score, and number of previous fistula treatment were recorded. The clinical examination defined healing, insufficiency or recurrence of the fistula. RESULTS: Fifty-four consecutive patients are undergoing surgery: 26 patients underwent LIFT and 28 underwent VAAFT. During the 18 months of follow-up there were no differences in terms of AM, CCFIS and VAS scores. Days of healing, failure, and recurrence rate were comparable in both groups. The subgroup of patients with local abscess undergoing LIFT showed worse results in terms of failure and recurrence rate (p < 0.05). CONCLUSIONS: Both techniques are safe and effective and can offer long-term benefits. LIFT should not be used as a first treatment in high trans-sphincteric fistula with perianal abscess.

Ovarian dermoid cyst presenting with unusual complaint of hair coming out of the anal orifice - A case report.

Dermoid cyst of the ovary is a common benign condition. It is usually asymptomatic but can present with pain, mass, hormone related symptoms or paraneoplastic syndrome. Hair is a common morphological component of the dermoid cyst; however, it rarely manifests as a presenting complain. We report a case, who presented with the complaints of hair coming out through her anal orifice for a year. Ultrasound and computed tomography scan revealed a dermoid cyst of the right ovary adherent to the rectum. Surgical removal showed hair coming out of the cyst. Primary repair of the defect in rectal wall was performed which resulted in resolution of the symptoms.

Ligation of the Intersphincteric Fistula Tract and Endorectal Advancement Flap for High Perianal Fistulas in Crohn's Disease: A Retrospective Cohort Study.

BACKGROUND AND AIMS: Ligation of the intersphincteric fistula tract [LIFT] and advancement flap [AF] procedures are well-established, sphincter-preserving procedures for closure of high perianal fistulas. As surgical fistula closure is not commonly offered in Crohn's disease patients, long-term data are limited. This study aims to evaluate outcomes after LIFT and AF in Crohn's high perianal fistulas. METHODS: All consecutive Crohn's disease patients ≥18 years old treated with LIFT or AF between January 2007 and February 2018 were included. The primary outcome was clinical healing and secondary outcomes included radiological healing, recurrence, postoperative incontinence and Vaizey Incontinence Score. RESULTS: Forty procedures in 37 patients [LIFT: 19, AF: 21, 35.1% male] were included. A non-significant trend was seen towards higher clinical healing percentages after LIFT compared to AF [89.5% vs 60.0%; p = 0.065]. Overall radiological healing rates were lower for both approaches [LIFT 52.6% and AF 47.6%]. Recurrence rates were comparable: 21.1% and 19.0%, respectively. In AF a trend was seen towards higher clinical healing percentages when treated with anti-tumour necrosis factor/immunomodulators [75.0% vs 37.5%; p = 0.104]. Newly developed postoperative incontinence occurred in 15.8% after LIFT and 21.4% after AF. Interestingly, 47.4% of patients had a postoperatively improved Vaizey Score [LIFT: 52.9% and AF: 42.9%]. The mean Vaizey Score decreased from 6.8 [SD 4.8] preoperatively to 5.3 [SD 5.0] postoperatively [p = 0.067]. CONCLUSIONS: Both LIFT and AF resulted in satisfactory closure rates in Crohn's high perianal fistulas. However, a discrepancy between clinical and radiological healing rates was found. Furthermore, almost half of the patients benefitted from surgical intervention with respect to continence.

Natural History of Perianal Fistulising Lesions in Patients With Elderly-onset Crohn's Disease: A Population-based Study.

INTRODUCTION: Most studies of elderly-onset Crohn's disease [CD; diagnosed in patients aged 60 or over] have described a mild course. However, data on the natural history of perianal fistulising CD [pfCD] in this population are scarce. In a population-based cohort study, we described the prevalence, natural history, and treatment of pfCD in patients with elderly-onset CD vs patients with paediatric-onset CD. METHOD: All patients diagnosed with CD at or after the age of 60 between 1988 and 2006, were included [n = 372]. Logistic regression, Cox models, and a nested case-control method were used to identify factors associated with pfCD. RESULTS: A total of 34 elderly patients [9% of the 372] had pfCD at diagnosis. After a median follow-up of 6 years (interquartile range [IQR]: 3; 10), 59 patients [16%] had pfCD; the same prevalence [16%] was observed in paediatric-onset patients. At last follow-up, anal incontinence was more frequent in elderly patients with pfCD than in elderly patients without pfCD [22% vs 4%, respectively; p < 10-4]. Rectal CD at diagnosis was associated with pfCD: hazard ratio (95% confidence interval [CI] = 2.8 [1.6-5.0]). Although 37% of the patients received immunosuppressants and 17% received anti-tumour necrosis factor agents, 24% [14 out of 59] had a definitive stoma at last follow-up. CONCLUSION: During the first 6 years of disease, the prevalence of pfCD was similar in elderly and paediatric patients. Rectal involvement was associated with the appearance of pfCD in elderly-onset patients. Around a quarter of patients with elderly-onset CD will have a stoma. Our results suggest that treatment with biologics should be evaluated in these patients.

Autologous adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistula: A randomized clinical trial with long-term follow-up.

The aim of this clinical trial (ID Number NCT01803347) was to determine the safety and efficacy of autologous adipose-derived stem cells (ASCs) for treatment of cryptoglandular fistula. This research was conducted following an analysis of the mistakes of a same previous phase III clinical trial. We designed a multicenter, randomized, single-blind clinical trial, recruiting 57 patients. Forty-four patients were categorized as belonging to the intent-to-treat group. Of these, 23 patients received 100 million ASCs plus intralesional fibrin glue (group A) and 21 received intralesional fibrin glue (group B), both after a deeper curettage of tracks and closure of internal openings. Fistula healing was defined as complete re-epithelialization of external openings. Those patients in whom the fistula had not healed after 16 weeks were eligible for retreatment. Patients were evaluated at 1, 4, 16, 36, and 52 weeks and 2 years after treatment. Results were assessed by an evaluator blinded to the type of treatment. After 16 weeks, the healing rate was 30.4% in group A and 42.8% in group B, rising to 55.0% and 63.1%, respectively, at 52 weeks. At the end of the study (2 years after treatment), the healing rate remained at 50.0% in group A and had reduced to 26.3% in group B. The safety of the cellular treatment was confirmed and no impact on fecal continence was detected. The main conclusion was that autologous ASCs for the treatment of cryptoglandular perianal fistula is safe and can favor long-term and sustained fistula healing.

Ligation of the Intersphincteric Fistula Tract for High Transsphincteric Fistula Yields Moderate Results at Best: Is the Tide Turning?

BACKGROUND: Ligation of the intersphincteric fistula tract is a well-accepted and often used surgical procedure for perianal fistulas. OBJECTIVE: This study aims to confirm results of the ligation of the intersphincteric fistula tract in a specialized colorectal center. DESIGN: This is a retrospective cohort study. SETTING: This study took place in a large colorectal surgical department with a tertiary referral center for perianal fistulas. PATIENTS: Consecutive patients were operated on with ligation of the intersphincteric fistula tract for a transsphincteric perianal fistula between 2012 and December 2018. INTERVENTIONS: Patients underwent ligation of the intersphincteric fistula tract. MAIN OUTCOME MEASURES: The primary outcome measured was the healing rate. The secondary outcomes measured were conversion into an intersphincteric perianal fistula, risk of recurrence, complications, and postoperative continence status. RESULTS: Forty-six patients were treated with a ligation of intersphincteric fistula tract procedure. All patients (100%) had preoperative imaging in their workup. Forty patients (87%) had a high transsphincteric fistula. The primary healing rate was a disappointing 17 of 46 patients (37%). The median time until failure was 4.2 months (interquartile range, 3.5-6.5). Of the failures, 16 converted to an intersphincteric fistula (55% of failures and 35% of all patients). The mean duration of follow-up in patients without a recurrence was 9.5 months (SD 11.9). Four patients (9%) were lost to follow-up. The mean Fecal Incontinence Severity Index postoperatively was only 2.35 (SD 5.7; range, 0-30). This resulted in 9 patients (20%) having a newly impaired continence status postoperatively. Continence impairment was mild in all these patients. The risk of developing a recurrence 1 year after surgery is 64.2% (95% CI, 49%-80%). LIMITATIONS: This study was limited by its retrospective design and the small numbers with possible selection bias. CONCLUSIONS: Results with the ligation of intersphincteric fistula tract procedure were not as good as hoped. The effect on fecal continence, however, was minimal. The procedure might be more suitable for low transsphincteric fistulas. See Video Abstract at http://links.lww.com/DCR/A992. LA LIGADURA DEL TRACTO DE LA FÍSTULA INTERESFINTÉRICA PARA UNA FÍSTULA TRANSESFINTÉRICA ALTA, PRODUCE RESULTADOS MODERADOS EN EL MEJOR DE LOS CASOS: ¿ESTÁ CAMBIANDO LA MAREA?: La ligadura del tracto de la fístula interesfintérica es un procedimiento quirúrgico bien aceptado y de uso frecuente para las fístulas perianales. OBJETIVO: Confirmar los resultados de la ligadura del tracto de la fístula interesfintérica en un centro colorrectal especializado. DISEÑO:: Estudio de cohorte retrospectivo. AJUSTE: Gran departamento de cirugía colorrectal y con centro de referencia terciaria para fístulas perianales. PACIENTES: Pacientes consecutivos operados con ligadura del tracto de la fístula interesfintérica para una fístula perianal transesfintérica, entre 2012 y diciembre de 2018. INTERVENCIONES: Ligadura del tracto de fístula interesfintérica. PRINCIPALES MEDIDAS DE RESULTADO: Tasa de cicatrización, resultados secundarios: conversión a una fístula perianal interesfintérica, riesgo de recurrencia, complicaciones y estado de continencia postoperatoria. RESULTADOS: Cuarenta y seis pacientes fueron tratados con una ligadura del tracto de la fístula interesfintérica. Todos los pacientes (100 por ciento) tenían imagenología en su preparación preoperatoria. Cuarenta pacientes (87 por ciento) tenían una fístula transesfintérica alta. La tasa de cicatrización primaria fue decepcionante en 17 de 46 pacientes (37 por ciento). El tiempo medio hasta el fracaso fue de 4.2 meses (rango intercuartil 3.5-6.5). De los fracasos, 16 se convirtieron en una fístula interesfintérica (55 por ciento de los fracasos y 35 por ciento de todos los pacientes). La duración media del seguimiento en pacientes sin recurrencia fue de 9.5 meses (desviación estándar de 11.9). Se perdieron durante el seguimiento a cuatro pacientes (9 por ciento). Después de la operación, el promedio del índice de severidad de incontinencia fecal fue de solo 2.35 (desviación estándar de 5.7, rango 0-30). Esto resultó en que 9 pacientes (20 por ciento) tuvieran una continencia deteriorada postoperatoria. El deterioro de la continencia fue leve en todos estos pacientes. El riesgo de desarrollar una recurrencia a un año después de la cirugía es del 64.2 por ciento (intervalo de confianza del 95 por ciento: 49-80 por ciento). LIMITACIONES: Diseño retrospectivo, números pequeños con posible sesgo de selección. CONCLUSIONES: Los resultados del procedimiento con la ligadura del tracto de fístula interesfintérica no fueron tan buenos como se esperaba. El efecto sobre la continencia fecal, sin embargo, fue mínimo. El procedimiento podría ser más adecuado para las fístulas transesfintéricas bajas. Vea el Resumen del video en http://links.lww.com/DCR/A992.

Elicitation of Health-Related Utility in Perianal Fistula in Crohn's Disease.

BACKGROUND AND OBJECTIVE: Perianal fistulae are a common complication of Crohn's disease (CD) and pose a substantial burden on quality of life. Data capturing health-related utility associated with perianal fistulae in CD are scarce. The current study aims to value health states related to different stages of the disease to quantitatively evaluate the impact of complex perianal fistulae on CD patients' quality of life. METHODS: Eight health state descriptions associated with complex perianal fistulae in CD were developed following qualitative research with patients and validation by clinicians. Following pre-testing, a survey was administered online in two samples of UK respondents: the general population and patients with CD. A choice-based valuation technique, the time trade-off (TTO), was used for direct utility measurement. CD patients also valued their current health state using the TTO. Exclusion criteria for respondents displaying logical inconsistencies were applied. RESULTS: Usable responses were received from 835 respondents, reflective of the UK population in age and sex, in the general population survey and 162 CD patients in the patient survey. Non-remission states were valued much lower than the remission state by both samples, ranging from 0.20 for proctectomy with a negative outcome to 0.66 for chronic symptomatic fistulae with mild symptoms. Patients currently experiencing fistulae reported lower values for current health than those without fistulae. CONCLUSION: Low utility values were assigned to the non-remission health states for perianal fistulae in CD by the general public and patients with CD. This demonstrates the high humanistic burden of inadequately managed perianal fistula in CD.

Identifying Outcomes in Clinical Trials of Fistulizing Crohn's Disease for the Development of a Core Outcome Set.

Fistulizing complications develop in approximately one third of patients with Crohn's disease (CD), resulting in morbidity and impaired quality of life.1 Sites of fistulae most commonly include perianal fistulae, but also enterocutaneous, enteroenteric, enterovesical, and rectovaginal. Its management requires combined medical and surgical strategies to prevent abscess formation and induce healing. Biologic agents have improved the medical treatment of CD-related fistulae, but many patients still require surgical intervention. Hence, there is considerable interest in the development of novel pharmaceutical agents to treat fistulizing CD.

Mucosal advancement flap for recurrent complex anal fistula: a repeatable procedure.

PURPOSE: Mucosal advancement flap (MAF) is the best option for complex anal fistula (AF) treatment. Recurrence is not rare and the best surgical option for his handling is a challenge considering the incontinence risk and the healing rate. We aimed to determine the feasibility and outcomes of a second MAF for recurrent complex AF previously treated with mucosal advancement flap. METHODS: We retrospectively identified 32 patients undergoing two or more MAF for recurrent AF in a larger cohort of 121 consecutive cases of MAF operated by the same senior colorectal surgeon. Only complex AF of cryptoglandular origin was enrolled. A long-term follow-up was performed collecting clinical and functional data. RESULTS: Among 121 patients (group A) treated with mucosal advancement flap, 32 (26.4%) (group B) recurred with a complex AF requiring a second mucosal advancement flap procedure. Success rate of group B is 78.1%. Six patients of group B recurred a second time, another MAF was performed with healing in all cases. Complication rate (Clavien Dindo 3b) of group B is 9.4% compared to 8.3% of group A. A slight continence deficit (Miller score 1, 2, and 4) was detected after the first MAF in 3 patients. The Miller score for these patients did not change after the subsequent MAF. CONCLUSIONS: MAF is effective for treatment of complex recurrent AF. A pre-existing MAF procedure does not worsen the healing rate of the second flap. The rate of surgical complications is similar with those reported in the literature for MAFs.

LONG-TERM OUTCOMES OF LIGATION OF INTERSPHINCTERIC FISTULA TRACT FOR COMPLEX FISTULA-IN-ANO: MODIFIED OPERATIVE PROCEDURE EXPERIENCE.

BACKGROUND: It is important but difficult to treat complex fistula-in-ano due to the high recurrent rate and following incontinence. Ligation of the intersphincteric fistula tract (LIFT), a novel surgical procedure with the advantage of avoiding anal incontinence, has a variable success rate of 57-94.4 %. AIM: To evaluate the long-term outcomes of modified LIFT operative procedure - ligation of intersphincteric fistula tract - to treat complex fistula-in-ano. METHODS: Retrospective analysis of 62 cases of complex fistula-in-ano. The group was treated with the modified approach of LIFT (curved incision was made in the anal canal skin; purse-string suture was performed around the fistula; the residual fistulas were removed in a tunnel-based way) and had a follow-up time of more than one year. Patient´s preoperative general condition, postoperative efficacy and their anal function were compared. RESULTS: The median age of the participants was 34, and 43 (69.4%) cases were male. Forty-one (66.1%) cases were of high transsphincteric fistula, four (6.5%) cases of high intrasphincter fistula, and 17 (27.4%) cases of anterior anal fistula in female. The median follow-up duration was 24.5 (range, 12-51) months. The success rate in the end of follow-up was 83.9% (52/62). The anorectal pressure and Cleveland Clinic Florida Fecal Incontinence (CCF-FI) evaluated three months before and after the operation did not find apparent changes. CONCLUSIONS: Compared with LIFT, the modified LIFT remarkably reduces postoperative failure and the recurrence rate of complex fistula with acceptable long-term outcomes.

Outcomes and Quality of Life Among Men After Anal Sphincter-Sparing Transperineal Rectourethral Fistula Repair.

OBJECTIVE: To describe long-term quality of life (QOL) outcomes after rectourethral fistula (RUF) repair. RUF is a debilitating diagnosis and complex surgical dilemma with limited data regarding QOL after repair. METHODS: Patients at a tertiary referral center undergoing transperineal RUF repair 1/2009-5/2016 were analyzed. Patients were contacted by telephone to assess QOL following repair. Descriptive analysis performed of short-term surgical data (success and complications) and long-term QOL data (novel questionnaire). RESULTS: Twenty one men underwent RUF surgery with 95% success after initial repair. Fifty two percent had a history of radiation and/or ablation. Four individuals (19%) experienced a Clavien-Dindo complication within 30 days, with 3 of those being grade III+. Fifteen had postoperative urinary incontinence, of whom 73% underwent artificial urinary sphincter placement. Three previously radiated individuals underwent subsequent urethral stricture surgery. At long-term follow-up (mean 45.6 ± 27.1 months), 53% reported perineal pain, 43% reported problems related to the gracilis flap, and 80% reported urinary incontinence (primarily occasional mild leakage). Twenty one percent were unable to do the things they wanted in their daily lives, while 80% reported that surgery positively impacted their life. None would have opted for complete urinary diversion. CONCLUSION: RUF repair leads to patient satisfaction and improved QOL, despite possible residual issues such as perineal pain and urinary incontinence. Definitive RUF repair should be offered to suitable radiated and nonradiated patients.

3D high-resolution anorectal manometry in patients with perianal fistulas: comparison with 3D-anal ultrasound.

BACKGROUND: Perianal fistula surgery can damage the anal sphincters which may cause faecal incontinence. By measuring regional pressures, 3D-HRAM potentially provides better guidance for surgical strategy in patients with perianal fistulas. The aim was to measure regional anal pressures with 3D-HRAM and to compare these with 3D-EUS findings in patients with perianal fistulas. METHODS: Consecutive patients with active perianal fistulas who underwent both 3D-EUS and 3D-HRAM at a clinic specialised in proctology were included. A group of 30 patients without fistulas served as controls. Data regarding demographics, complaints, previous perianal surgical procedures and obstetric history were collected. The mean and regional anal pressures were measured with 3D-HRAM. Fistula tract areas detected with 3D-EUS were analysed with 3D-HRAM by visual coding and the regional pressures of the corresponding and surrounding area of the fistula tract areas were measured. The study was granted by the VUmc Medical Ethical Committee. RESULTS: Forty patients (21 males, mean age 47) were included. Four patients had a primary fistula, 19 were previously treated with a seton/abscess drainage and 17 had a recurrence after previously performed fistula surgery. On 3D-HRAM, 24 (60%) fistula tract areas were good and 8 (20%) moderately visible. All but 7 (18%) patients had normal mean resting pressures. The mean resting pressure of the fistula tract area was significantly lower compared to the surrounding area (47 vs. 76 mmHg; p < 0.0001). Only 2 (5%) patients had a regional mean resting pressure < 10 mmHg of the fistula tract area. Using a Δ mean resting pressure ≥ 30 mmHg difference between fistula tract area and non-fistula tract area as alternative cut-off, 21 (53%) patients were identified. In 6 patients 3D-HRAM was repeated after surgery: a local pressure drop was detected in one patient after fistulotomy with increased complaints of faecal incontinence. CONCLUSIONS: Profound local anal pressure drops are found in the fistula tract areas in patients normal mean resting pressures. Fistulotomy may affect local sphincter pressure. This might influence surgical decision making in future.