Cleveland Clinic Florida Fecal Incontinence Research Articles

Impact of Internal Anal Sphincter Division on Continence Disturbance in Female Patients.

Few studies measured the pre- and postoperative anatomic and functional anal canal using 3-dimensional endoanal ultrasound and anal manometry and correlated sphincter division with fecal incontinence, severity, and function. To assess the incidence of fecal incontinence in patients who underwent internal anal sphincter division for anal fissure or intersphincteric anal fistula and correlate severity of symptoms with percentage of divided muscle, anatomical measurements, and anal pressures. Prospective cohort study. Colorectal surgery unit, tertiary referral center. Patients underwent clinical assessment using the Cleveland Clinic Florida Fecal Incontinence score for severity of symptoms, manometry, and ultrasound. Ultrasound measurements of length, percentage, and angle of divided internal anal sphincter, anterior external anal sphincter, posterior external anal sphincter plus puborectalis, and gap lengths. Sixty-three women (mean age, 44 years) were divided into 2 groups: 30 (48%) underwent fistulotomy for intersphincteric anal fistula and 33 (52%) underwent sphincterotomy for chronic anal fissure with high anal resting pressure. Forty-six percent experienced some measure of fecal incontinence after internal anal sphincter division. Incidence of fecal incontinence, severity of symptoms, and angle of the divided internal anal sphincter were similar between the groups. Length and percentage of the divided internal anal sphincter were significantly higher in the intersphincteric anal fistula. External anal sphincter and external anal sphincter plus puborectalis lengths were similar in both groups. Gap length was significantly longer in chronic anal fissures with high anal resting pressure. Single-institution, exclusion of males. Fecal incontinence was reported in half of the patients who underwent internal anal sphincter division. Despite the greater length and percentage of internal anal sphincter division in patients who underwent fistulotomy, incidence and severity of fecal incontinence were similar in both groups. Three-dimensional endoanal ultrasound showed greater gap length in the sphincterotomy group, which may be functionally significant after the division of the shorter internal anal sphincter but with a similar impact on fecal incontinence in both groups. ANTECEDENTES:Pocos estudios han medido el canal anal anatómico y funcional antes y después de la cirugía mediante ecografía endoanal tridimensional y manometría anal, y correlacionado la división del esfínter con la incontinencia fecal, la gravedad y la función.OBJETIVO:Evaluar la incidencia de incontinencia fecal en pacientes sometidos a división del esfínter anal interno por fisura anal o fístula anal interesfinteriana, y correlacionar la gravedad de los síntomas con el porcentaje de músculo dividido, las medidas anatómicas y las presiones anales.DISEÑO:Estudio de cohorte prospectivo.AJUSTE:Unidad de cirugía colorrectal, centro de referencia de tercer nivel.PACIENTES:Pacientes sometidos a una evaluación clínica utilizando la puntuación de incontinencia fecal de Cleveland Clinic Florida para la gravedad de los síntomas, la manometría y la ecografía.PRINCIPALES MEDIDAS DE RESULTADO:Mediciones por ultrasonido de la longitud, el porcentaje y el ángulo del esfínter anal interno dividido y el esfínter anal externo anterior, el esfínter anal externo posterior más el puborrectal y las longitudes del espacio.RESULTADOS:Sesenta y tres mujeres (edad media, 44 años) se dividieron en 2 grupos: 30 (48%) sometidos a fistulotomía por fístula anal interesfinteriana y 33 (52%) sometidos a esfinterotomía por fisura anal crónica con alta presión anal en reposo. El 46% experimentó algún grado de incontinencia fecal después de la división del esfínter anal interno. La incidencia de incontinencia fecal, la gravedad de los síntomas y el ángulo del esfínter anal interno dividido fueron similares entre los grupos. La longitud y el porcentaje del esfínter anal interno dividido fueron significativamente mayores en la fístula anal interesfinteriana. Las longitudes del esfínter anal externo y del esfínter anal externo más el puborrectal fueron similares en ambos grupos. La longitud del espacio fue significativamente mayor en la fisura anal crónica con alta presión anal en reposo.LIMITACIONES:Institución única, exclusión de varones.CONCLUSIÓN:La incontinencia fecal se reportó en la mitad de los pacientes sometidos a división del esfínter anal interno. A pesar de la mayor longitud y porcentaje de división del esfínter anal interno en los pacientes sometidos a fistulotomía, la incidencia y gravedad de la incontinencia fecal fue similar en ambos grupos. La ecografía endoanal tridimensional mostró una mayor longitud del espacio en el grupo de esfinterotomía, lo que puede ser funcionalmente significativo después de la división del esfínter anal interno más corto, pero con un impacto similar en la incontinencia fecal en ambos grupos. (Traducción-Dr. Fidel Ruiz Healy ).

Unstimulated Gluteus Maximus Sphincteroplasty for Bowel Incontinence.

Background Gluteus maximus, by virtue of its continued adjunct contraction with the anal sphincter, has many characteristics and histomorphological features mimicking type I musculature. Hence, anal sphincter replacement therapy with gluteus maximus has all avenues for lasting successful results. This study aimed to evaluate the efficiency of unstimulated gluteus maximus sphincteroplasty for anal incontinence reconstruction and neosphincter reconstruction in perineal colostomy cases. Methods From March 2015 to March 2020, the records of patients who underwent gluteus maximus sphincteroplasty for fecal incontinence were analyzed in this retrospective cohort study. The mean age was 31.55 years. Eleven patients (females = 4, males = 7) underwent anal incontinence reconstruction. All these cases were followed up for an average period of 28.46 months. Results Good continence was observed in all patients with an average Cleveland Clinic Florida Faecal Incontinence Score of 3.18 ( p = 0.0035). At the end of the follow-up period, the average median resting pressure found via manometry was 44.64 mm Hg, and the average median squeeze pressure was 103.55mm Hg. The mean of the average continence contraction time at the end of the follow-up period was found to be 3.64 minutes. None of our patients had complete continence failure. None of our patients used perineal pads or made any lifestyle alterations at the end of the follow-up period. Most of the patients expressed satisfactory continence. Conclusion Despite being untrained with implantable electrodes, the gluteus maximus muscle produced very good continence results with our way of construct. In addition, with its good lumen occluding effect, it achieves good resting and squeeze anal pressure around the anal canal/bowel with trivial reeducation. Hence, it has become our institution's procedure of choice for anal sphincter reconstruction.

Simple Anal Reinforcement with Anal Encirclement Using an Artificial Ligament in Patients with fecal Incontinence: A Single-center Observational Study

Objectives: Surgical repair of anal sphincter defects in patients with fecal incontinence (FI) has been associated with excellent or good short-term results; however, its benefits have been shown to deteriorate over long-term follow-up. When sphincteroplasty fails or is not feasible, the subsequent surgical options are limited. This study aimed to evaluate the efficacy of anal encirclement using the Leeds-Keio ligament in patients with FI. Methods: The inclusion criteria for the procedure were failure of or unsuitability for sphincteroplasty and the presence of a patulous anus (diameter, ≥35 mm). The artificial ligament was routed outside the external anal sphincter at the depth of the middle anal canal under caudal epidural anesthesia. Results: Fourteen patients (mean age, 79.4 years; 8 females) with FI were included. Of these, seven (50%) showed a ≥50% reduction in the Cleveland Clinic Florida Fecal Incontinence Score (CCFIS). The mean CCFIS of 13.6 at baseline significantly improved to 7.9 3 months after surgery. The mean maximal anal resting pressure significantly increased from 16.8 mmHg to 22.6 mmHg. Postoperatively, temporary fecal impaction was observed in one patient (7%). None of the cases required removal of the artificial ligament or additional operative interventions for FI during the mean follow-up period of 31.9 months. Conclusions: Anal encirclement using the Leeds-Keio ligament was technically simple and safe and achieved good short-term outcomes. Therefore, this technique appears to be a simple solution for sphincter defects and may become an important surgical option for patients with FI and a patulous anus.

Therapeutic Effect of Changqiang Acupoint Injection on Children with Functional Fecal Incontinence

Objective: Functional fecal incontinence in children (FFIC), also known as functional fecal disorder in children, is a type of childhood diseases characterized by excretory dysfunction. In the study, we observed the clinical effect of Changqiang acupoint injection on functional fecal incontinence in children (FFIC) by randomized controlled clinical trials.<br/> Materials and methods: 140 children with functional fecal incontinence who met the screening criteria were respectively assigned into the treatment group (100 cases) and the control group (40 cases) according to the completely randomized controlled design. In the treatment group, Chuankezhi injection was administrated at the Changqiang acupoint once a week for three weeks (one course of treatment). In contrast, the subjects in the control group was instructed to receive sphincter exercise and defecation training, followed by an assessment on the therapeutic efficacy after one course of treatment.<br/> Results: The overall response rate of the two groups was 93.00% (93/100) and 57.50% (23/40), respectively, with a statistically significant difference (P<0.01). The treatment group showed a performance superior to the control group based on the Cleveland Clinic Florida Fecal Incontinence Score System (CCF-FI) — dry stool incontinence, liquid incontinence, gas incontinence, lifestyle change, necessity of using pads or antidiarrheals, the ability to delay defecation, and the total score. The inter-group comparison revealed a statistically significant difference (P<0.01).<br/> Conclusion: Changqiang acupoint injection has significant curative effect on FFIC as demonstrated by significant relief in the symptoms associated with fecal incontinence, and thus is considered as a useful approach to be widely applied in clinical practice.

Administration of an Anal Bulking Agent With Polyacrylate-Polyalcohol Copolymer Particles Versus Endoanal Electrical Stimulation With Biofeedback for the Management of Mild and Moderate Anal Incontinence: A Randomized Prospective Study

There are few treatment options for mild-to-moderate anal incontinence with isolated internal anal sphincter defects or anal incontinence without muscle damage. Less-invasive techniques are generally favored. To compare the results between the use of an anal bulking agent with polyacrylate-polyalcohol copolymer particles and endoanal electrical stimulation with biofeedback in patients with mild or moderate anal incontinence. This was a prospective parallel-group, single-institution, randomized clinical trial. This study was conducted in an ambulatory setting at the Colorectal Physiology Service of the Hospital das Clinicas, Medical School, University of Sao Paulo. This study included patients who had anal incontinence for >6 months with isolated internal anal sphincter muscle damage or absence of anatomical defects in the anorectal sphincter complex. Anal bulking agent and endoanal electrical stimulation with biofeedback. The primary outcome measure was the Cleveland Clinic Florida Fecal Incontinence Score, and the secondary outcome measures included quality of life, recommended procedures, and anorectal manometry. There were no significant between-group differences in mean age, sex, BMI, stool consistency, and Cleveland Clinic Florida Fecal Incontinence Score (p = 0.20) at baseline. After 12 months, the Cleveland Clinic Florida Fecal Incontinence Score was found to be significantly improved in patients treated with the bulking agent compared to those treated with electrical stimulation (mean, 6.2 vs 9.2; p = 0.002), though the anorectal manometry parameters did not change significantly. The mean anal Cleveland Clinic Florida Fecal Incontinence Score declined by 4.2 points in the bulking agent group compared to a decline of 0.8 in the electrical stimulation group (mean difference in decline: 3.4 points; 95% CI, 1.2-5.5). Quality-of life evaluation showed similar results between groups comparing baseline parameters with 12-month follow-up. The short follow-up period of 1 year, atypical method of biofeedback, and unmatched baseline in some of the quality-of-life scales between the 2 groups limited this study. In patients with mild or moderate anal incontinence, the Cleveland Clinic Florida Fecal Incontinence Score significantly improved in the bulking agent with polyacrylate-polyalcohol copolymer group compared with the endoanal electrical stimulation with biofeedback group. See Video Abstract at http://links.lww.com/DCR/B938. ANTECEDENTES:Hasta la fecha, existen pocas opciones de tratamiento para la incontinencia anal de leve a moderada con defectos aislados del esfínter anal interno o la incontinencia anal sin daño muscular. Por lo general, se prefieren técnicas menos invasivas.OBJETIVO:El objetivo fue comparar los resultados entre el uso de un gel intra-anal con partículas de copolímero de poliacrilato-polialcohol y la estimulación eléctrica endoanal con ejercicios anales en pacientes con incontinencia anal leve o moderada.DISEÑO:Este fue un ensayo clínico aleatorio prospectivo de grupos paralelos, de una institución, realizado en cuatro etapas: base, procedimientos, postratamiento temprano y tardío.AJUSTE:Este estudio se realizó en el ambulatorio de Fisiología Colorrectal del Servicio de Coloproctología del Hospital das Clínicas, Facultad de Medicina, Universidad de São Paulo.PACIENTES:Paciente con incontinencia anal con más de 6 meses, con daño muscular aislado del esfínter anal interno o ausencia de defectos anatómicos en el esfínter anorrectal.INTERVENCIONES:Las intervenciones incluyeron la inyección del gel intra-anal y estimulación eléctrica endoanal con ejercicios anales.PRINCIPALES MEDIDAS DE RESULTADO:Indice de incontinencia fecal (Cleveland Clinic Florida), Indice de calidad de vida, los procedimientos recomendados y la manometría anorrectal.RESULTADOS:No hubo diferencias significativas entre los grupos en cuanto a la edad media, el sexo, el índice de masa corporal, la consistencia de las heces y la puntuación de incontinencia fecal (p = 0,20) al inicio del estudio. Después de 12 meses, la puntuación de incontinencia fecal mejoró significativamente en los pacientes tratados con el el gel intra-anal (media = 6,2) en comparación con los tratados con estimulación eléctrica (media = 9,2; p = 0,002), aunque los parámetros de manometría anorrectal no mejoraron significativamente. La puntuación anal media de incontinencia fecal disminuyó 4,2 puntos en el grupo del Gel intra-anal en comparación con 0,8 en el grupo de estimulación eléctrica (diferencia media en la disminución: 3,4 puntos; IC del 95%: 1,2 a 5,5). La evaluación de la calidad de vida mostró resultados similares entre los grupos que compararon los parámetros iniciales con un seguimiento de 12 meses.LIMITACIONES:Breve período de seguimiento de un año, métodos diferentes de ejercicios anales y línea de base sin igual en algunas de las escalas de calidad de vida entre los dos grupos.CONCLUSIONES:En pacientes con incontinencia anal leve y moderada, la puntuación de incontinencia fecal mejoró significativamente en el grupo de gel intra-anal con copolímero de poliacrilato-polialcohol en comparación con la estimulación eléctrica endoanal. Consulte Video Resumen en http://links.lww.com/DCR/B938. (Traducción- Dr Leonardo Alfonso Bustamante-Lopez).

Prospective, Randomized, Controlled Trial of Ultra-modified Internal Sphincterotomy vs Closed Lateral Internal Sphincterotomy for Chronic Fissure-in-Ano

Currently, the lateral internal sphincterotomy is the treatment of choice for a chronic anal fissure (CAF). However, the length of the internal sphincter incision varies, due to lack of standardization. Insufficient length increases the risk of recurrence. To compare a new ultra-modified internal sphincterotomy (UMIS) to the closed lateral internal sphincterotomy (CLIS) for treating CAF, based on internal anal sphincter function and postoperative complications. The primary endpoint was continence after UMIS. The secondary outcomes were CAF healing complications, visual analog scale pain scores, and sphincter pressures. This was a prospective, randomized, controlled trial (block randomization method). 200 patients with CAFs were randomly assigned to receive either UMIS (n = 100) or the closed lateral internal sphincterotomy (CLIS) (n = 100). Follow-up was 2years. RESULTS: All (100%) patients in both groups showed clinical improvement at 1month post-surgery. Recurrences were accompanied by deteriorations in Cleveland Clinic Florida Fecal Incontinence scores at 12months and 2years (P < .05). The groups showed significant differences in fissure healing rates and pain scores. After 1 and 2years, incontinence rates were significantly higher, and patient satisfaction scores were significantly lower in the CLIS group than the UMIS group (P < .05). UMIS provided a faster healing rate and fewer side effects than the CLIS for treating CAFs. These results might lead to a standardized treatment among surgeons.

Fistulectomy and endorectal advancement flap repair for cryptoglandular anal fistula: recurrence and functional outcome over 10 years of follow-up.

To examine long-term recurrence and anal continence of patients with anal fistula treated by fistulectomy and endorectal advancement flap repair. Retrospective analysis of a prospective cohort of 115 patients (77.4% males, mean age 48.9 years) requiring 130 procedures, with a minimum follow-up of 10 years. Recurrence included reappearance of fistula after wound healing or presence of an abscess or chronic suppuration in the operated area at follow-up. Fecal incontinence was evaluated by the Cleveland Clinic Florida (CCF-FI) fecal incontinence scoring system. The mean and SD duration of the follow-up period was 155.5 (21.7) months. Recurrence developed in 31 (23.8%) cases, 28 (90.3%) of which within the first year, with a mean time to recurrence of 4.9 (2.9) months. The success rate was 76.2%. Anal continence was normal in 80% of patients before surgery, 63.8% at 1-year follow-up, and 71.5% at the end of follow-up (p < 0.001). Overall, continence worsened in 16.9% of cases. The mean (95% CI) CCF-FI score was 0.78 (0.35-1.21) preoperatively, 1.04 (0.64-1.43) at 1 year after surgery, 0.90 (0.52-1.29) at 5 years, and 1.16 (0.66-1.67) at the end of the study (p < 0.05). Neither recurrence nor continence was significantly associated with previous anal or fistula surgical procedures or complexity of the fistula. In this study, fistulectomy and endorectal advancement flap repair was associated with a long-term high rate of success. Most recurrences occurred within the first year and continence showed a mild deterioration over time. Not applicable.

Early Effects of High-intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer on Fecal Continence and Anorectal Physiology

To evaluate high-intensity focused ultrasound (HIFU) effects on anorectal physiology and fecal continence or constipation, and on quality of life (QoL). We prospectively evaluated 26 patients with localized prostate cancer who underwent HIFU. The Rome III criteria for functional constipation, the Cleveland Clinic Florida Fecal Incontinence Score, and the Fecal Incontinence QoL Score questionnaires were answered before and after treatment. Anorectal manometry was used to evaluate resting and squeezing pressures, sustained contraction, paradoxical puborectalis contraction, rectal sensation, and rectal capacity. Thirteen patients underwent hemiablation and 13 underwent whole-gland ablation. There was no difference between groups regarding the Rome III criteria for functional constipation results. The Cleveland Clinic Florida Fecal Incontinence Score results showed that 3 (11.5%) of patients had mild fecal incontinence before HIFU and 5 (19.2%) had it afterward (P=.625). No patients reported poor QoL due to fecal incontinence in the Fecal Incontinence QoL Score. Anorectal manometry demonstrated no decrease in resting pressure after treatment (P=.299), while squeezing pressure significantly increased from 151.87 to 167.91 mm Hg (P=.034). The number of patients with normal sustained contraction remained the same (20 [77%]). Paradoxical puborectalis contraction was seen in 12 (46%) of the patients before the procedure and in 13 (50%) after (P=.713). Improvement in sensory parameters was not significant: first sense changed from 73.46 to 49.71 mL (P=.542) and first urge from 98.27 to 82.88 mL (P=.106). Rectal capacity had a nonsignificant decrease from 166.15 to 141.15mL (P=.073). HIFU did not cause significant changes in anorectal physiology. Fecal incontinence or constipation after HIFU was not observed via validated questionnaires.

Prevalence of low anterior resection syndrome and impact on quality of life after rectal cancer surgery: population-based study.

BackgroundThe prevalence of major low anterior resection syndrome (LARS) after rectal cancer surgery varies from 17·8 to 56·0 per cent, but data from high‐quality studies are sparse. The aim of this study was to determine the prevalence of LARS and its association with quality of life (QoL) in a large, well defined, population‐based cohort.MethodsThis was a population‐based study that included all patients who had curative rectal cancer surgery with total or partial mesorectal excision in Stockholm County in Sweden between 2007 and 2013. Patients without a remaining stoma, free from cancer and alive in April 2017 were eligible for the study. The LARS score questionnaire, EORTC QLQ‐C30 and Cleveland Clinic Florida Fecal Incontinence score were used as outcome measures. Adjusted mean scores (and differences) of EORTC QLQ‐C30 for LARS groups were calculated using repeated measures ANCOVA regression models while adjusting for predefined confounders.ResultsIn total, 481 patients (82·6 per cent response rate) were included in the analysis. Mean follow‐up time was 6·7 (range 3·4–11·0) years after surgery. The prevalence of LARS was 77·4 per cent (370 of 478 patients), with 53·1 per cent (254 of 478) experiencing major LARS. Patients with major LARS reported worse on all EORTC QLQ‐C30 subscales (except for financial difficulties) than patients without LARS. A higher mean LARS score was associated with a greater impact on bowel‐related QoL.ConclusionAfter anterior resection for rectal cancer, the majority of patients suffer from major LARS with a negative impact on QoL.

Complex Anal Fistula: Long-Term Results of Modified Ligation of Intersphincteric Fistula Tract=LIFT.

Objectives:The anal fistula is a permanent infectious tunnel formed between the anal canal and skin in the perianal region. Fistulas are treated by surgery at any stage. Many surgical methods have been reported to treat anal fistula. One of the promising surgical methods with a high success rate is ligation of the intersphincteric fistula tract, which is performed in anatomical spaces without damage to the internal and external sphincters. We evaluated the success rate of a modified ligation of the intersphincteric fistula tract procedure for complex anal fistulas in which the technical differences were minimized by the surgery being performed by the same surgical team.Methods:In this study, Data of the 56 patients were retrospectively collected. Data regarding patient history, visual and digital anal examination, Cleveland Clinic Florida Fecal Incontinence (CCF-FI) score, anal-phase pelvic magnetic resonance imaging (MRI), rectosigmoidoscopy or colonoscopy and anal manometry were recorded. The changes in data recorded during the preoperative and postoperative periods were compared in each other.Results:The mean age of the patients was 41±15.5 years. The number of patients for each fistula type compromised in this study was as follows in accordance with frequency: high transsphincteric fistula, high intersphincteric fistula, and horseshoe abscess. The fistula recurred in seven patients during postoperative follow-up and the success rate of modified LIFT was calculated as 87.5%. The change in the mean±SD preoperative and postoperative CCF-FI scores and anal pressure was not statistically significant.Conclusion:One promising advantage of the ligation of the intersphincteric fistula tract procedure is that it turns a complex fistula into a simple fistula that can be treated with minimal risk of sphincter damage.

Long-term outcomes of radiofrequency treatment for fecal incontinence: are the results maintainable?

Temperature-controlled radiofrequency (RF) energy delivery to the sphincter complex has been proposed as an option for those patients not susceptible to a major surgical procedure for fecal incontinence (FI). The aim of the study was to evaluate the long-term (15years) functional outcomes obtained after RF procedure for FI. This was a retrospective analysis of our prospectively collected database of patients that underwent RF procedure for FI. Primary outcomes measured were the Cleveland Clinic Florida Fecal Incontinence scale (CCF-FI), Fecal Incontinence-related Quality of Life Score (FIQLS), the 36-Item Short Form survey (SF-36), endoanal ultrasound, and anorectal manometry. Evaluations were compared at baseline and at 15years of follow-up. Ten patients were followed up 15years after RF procedure. There was no significant improvement in the CCF-FI score (13.8 vs. 12.4, p = 0.24). No significant changes in the FIQLS were observed including lifestyle (2.39 vs. 2.13, p = 0.23), coping (1.91 vs. 1.92, p = 0.96), and embarrassment (1.66 vs. 1.86; p = 0.43). However, significant worsening was found in the depression category (2.47 vs. 1.60, p = 0.001). The SF-36 showed significant worsening in the mental (36.7 vs. 25.8, p < 0.001), physical (53.1 vs. 41.4, p = 0.01), and social functions (50.9 vs. 31.25, p = 0.001). Anorectal manometry and endoanal ultrasound showed no significant changes. No complications were found in the long-term follow-up. Radiofrequency procedure for fecal incontinence did not maintain its efficacy during long-term follow-up.

Appendicostomy Antegrade Colonic Irrigation by Electromechanical Pump, a Novel Method for Managing Fecal Incontinence, Randomized Clinical Trial

Antegrade colonic irrigation enema (ACIE) is established as an old treatment for child fecal incontinence and recently is approved as a treatment for different causes of adult fecal incontinence (cancer surgery, neurogenic bowel, spinal cord injury, sphincter trauma, etc.). Despite the benefits of emptying the large bowel and prevention of fecal incontinence or constipation, this method is time-consuming and requires thorough instruction and training. The purpose of this study was to innovate and assess novel technique to decrease time-consuming and improve performance of irrigation. We designed and electromechanical pump for colon irrigation and assessed by a randomized crossover clinical trial study, involving two-four weeks treatment phases. 30 patients have included that suffered fecal incontinence and had been managed with appendicostomy antegrade colon irrigation. The results showed that the pump decrease time and volume of irrigation compare with the traditional method. All patients had a reduction in toileting times. Traditional mean toileting time was 67 minutes, versus pump-toileting time that was 24.6 minutes (P:0.00). The volume of water was reduced in 13 patients. Mean of the volume was 1712 ml in the traditional method and 1128 ml in pump method (P:0.279). Mean Cleveland Clinic Florida Fecal Incontinence score (CCF_FIS) for the pump was 5.84 compare 6.24 for traditional method (P:0.000). Our study provides evidence for the first time that our novel method can facilitate and speed-up colon irrigation without any adverse effect on the outcome.&#x0D; © 2018 Tehran University of Medical Sciences. All rights reserved.&#x0D; Acta Med Iran 2018;57(4):216-223.

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

ABSTRACTBackground: 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.

FUNCTIONAL AND ANATOMICAL ANALYSIS OF THE ANORECTUM OF FEMALE SCLERODERMA PATIENTS AT A CENTER FOR PELVIC FLOOR DISORDERS.

Scleroderma or progressive systemic sclerosis is characterized by a chronic inflammatory process with proliferation of fibrous connective tissue and excessive deposition of collagen and extracellular matrix in the skin, smooth muscle, and viscera. The smooth muscle most involved in scleroderma is that of the esophagus, and dysphagia is the most commonly reported symptom. However, the internal anal sphincter may also be impaired by degeneration and fibrosis, leading to concomitant anal incontinence in scleroderma patients. These patients may neglect to complain about it, except when actively questioned. To assess anorectal function and anatomy of female scleroderma patients with symptoms of anal incontinence through Cleveland Clinic Florida Fecal Incontinence Score (CCFIS), anorectal manometry and endoanal ultrasound at the outpatient clinic of colorectal and anal physiology, Clinics Hospital, University of São Paulo Medical School (HC-FMUSP). Female scleroderma patients were prospectively assessed and questioned as to symptoms of anal incontinence. The anorectal manometry and endoanal ultrasound results were correlated with clinical data and symptoms. In total, 13 women were evaluated. Their mean age was 55.77 years (±16.14; 27-72 years) and their mean disease duration was 10.23 years (±6.23; 2-23 years). All had symptoms of fecal incontinence ranging from 1 to 15. Seven (53.8%) patients had fecal incontinence score no higher than 7; three (23.1%) between 8 and 13; and three (23.1%) 14 or higher, corresponding to mild, moderate, and severe incontinence, respectively. Ten (76.92%) patients had hypotonia of the internal anal sphincter. Three-dimensional endoanal ultrasound showed tapering associated with muscle atrophy of the internal sphincter in six cases and previous muscle defects in three cases. A functional and anatomical impairment of the sphincter is an important factor to assess in patients with progressive systemic sclerosis and it should not be underestimated.

Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence

The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Usefulness of anorectal and endovaginal 3D ultrasound in the evaluation of sphincter and pubovisceral muscle defects using a new scoring system in women with fecal incontinence after vaginal delivery.

This study aims to evaluate pubovisceral muscle and anal sphincter defects in women with previous vaginal delivery and fecal incontinence and to correlate the findings with the severity of symptoms using the combined anorectal and endovaginal 3D ultrasonography with a new ultrasound scoring system. Consecutive female patients with previous vaginal delivery and fecal incontinence symptoms were screened. Fecal incontinence was assessed with the Cleveland Clinic Florida fecal incontinence scale, and the extent of defects was assessed by an ultrasound score based on results of anorectal and endovaginal 3D ultrasound. Fecal incontinence was assessed with the Cleveland Clinic Florida fecal incontinence scale. Of 84 women with previous vaginal delivery and fecal incontinence, 21 (25%) had intact pubovisceral muscles and anal sphincters; 63 (75%) had a pubovisceral muscle or anal sphincter defect, or both. Twenty-eight (33%) had a pubovisceral muscle defect [23% with an external anal sphincter (EAS) defect or combined EAS/internal anal sphincter defects; 11% with intact anal sphincters]. Thirty-five (42%) had intact pubovisceral muscles and an anal sphincter defect. Compared with women with intact pubovisceral muscles/anal sphincter defects, patients with pubovisceral muscle defects had significantly higher incontinence scores and significantly higher ultrasound scores indicating more extensive defects. Incontinence symptoms correlated positively with the ultrasound score, measurements of sphincter defects, and area of the levator hiatus. Evaluation of both pubovisceral muscles and anal sphincters is important to identify defects and determine treatment for women with fecal incontinence after vaginal delivery. The severity of fecal incontinence symptoms is significantly related to the extent of defects of the pubovisceral muscles and anal sphincters.

Effective and long-term outcome following ligation of the intersphincteric fistula tract (LIFT) for transsphincteric fistula.

The purpose of this study was to evaluate the efficacy and long-term outcome of the ligation of the intersphincteric fistula tract (LIFT) procedure for transsphincteric fistula-in-ano. A total of 43 patients that were treated with LIFT procedure and had a follow-up time of more than 1year were included. The median age was 37.18years, and 32 (74.4%) of the patients were male. The median follow-up time was 26.2months (range 13-63months). There were 29 (67.4%) uncomplicated transsphincteric fistulas, 10 (23.3%) horseshoe transsphincteric fistulas, and 4 (9.3%) multiple fistulas. Eight (18.5%) patients presented with dehiscence or infection at the intersphincteric wound and were successfully treated with either laying open (n=5) or local application of silver nitrate (n=3). The success rate, as determined from the last follow-up time point, was 83.7% (36/43). The mean time to complete failure was 8.6weeks (range 1-28) in 7 patients. With the exception of these 7 patients, 32/36 (88.9%) patients had a Cleveland Clinic Florida Faecal incontinence score of 0, 3 patients had a score of 1, and 1 had a score of 2. No significant association was found between laying open and incontinence in these partial failure patients. The LIFT procedure can be considered an effective sphincter-sparing procedure in the management of transsphincteric fistula with an acceptable long-term outcome.

Functional outcomes after TEM in patients with complete clinical response after neoadjuvant chemoradiotherapy.

In patients who exhibit a complete clinical response after radio-chemotherapy for rectal cancer, the standard surgical approach might constitute overtreatment. The aim of this study is to analyse the outcomes of anorectal function and quality of life after transanal endoscopic microsurgery (TEM) in irradiated patients with complete clinical response. Between 2007 and 2014, 84 patients who were diagnosed with stage T2-T3-T4 N0 rectal cancer before chemoradiotherapy showed a complete clinical response to neoadjuvant therapy and underwent TEM. All patients were evaluated before and 1year after TEM using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) questionnaire to determine the impact of this surgical technique on the degree of faecal continence. To assess the quality of life of patients after surgery, we administered the Fecal Incontinence Quality of Life Scale. Twenty-three patients exhibited a worse incontinence status after surgical intervention (27.4; 95% CI 18.2-38.2). These patients experienced a median positive absolute variation in the CCF-FIS of four points (95% CI 3.5-4.5; p<0.001). Female sex and age showed a significant correlation with the worsening of continence status. Scores on the Fecal Incontinence Quality of Life Index Scale did not show a significant difference before and after TEM. TEM may be an alternative treatment for patients with rectal cancer who exhibit a complete clinical response to neoadjuvant chemoradiotherapy because it offers the possibility to achieve a full thickness excision of the rectal wall. TEM also allows the identification of any residual disease and provides optimal quality of life and functional results.

Identifying factors associated with clinical success in patients treated with NASHA(®)/Dx injection for fecal incontinence.

PurposeInjection with the bulking agent consisting of non-animal stabilized hyaluronic acid/dextranomer (NASHA®/Dx) is well tolerated and efficacious for the treatment of fecal incontinence (FI); however, the patient population that may derive maximum benefit has not been established. This post hoc responder analysis assessed demographic and baseline characteristics predictive of responsiveness to NASHA/Dx treatment.MethodsAdults with a Cleveland Clinic Florida fecal incontinence score (CCFIS) ≥10 were randomized to receive NASHA/Dx or sham treatment. The primary end point was response to treatment (ie, decrease from baseline of ≥50% in number of FI episodes) at 6 months; a prespecified secondary end point was change in fecal incontinence quality of life (FIQL) score at 6 months. Post hoc subgroup analyses were performed for baseline and demographic characteristics and prior FI treatments.ResultsOverall, response to treatment was significantly greater with NASHA/Dx versus sham injection (52.7% vs 32.1%; P=0.0089). All subgroups analyzed demonstrated evidence of improvement, favoring NASHA/Dx versus sham treatment for both response to treatment and change in the FIQL coping/behavior subscale score. For the primary end point, a significantly greater percentage of patients with CCFIS ≤15, FI symptoms ≤5 years’ duration, or obstetric causes of FI responded to NASHA/Dx treatment versus patients receiving sham treatment (51.1% vs 28.3%, P=0.0169; 55.4% vs 25.7%, P=0.0026; and 53.6% vs 23.1%, P=0.0191, respectively). The mean change in the FIQL coping/behavior score significantly favored NASHA/Dx versus sham treatment for patients with CCFIS ≤15 (P=0.0371), FI symptoms ≤5 years’ duration (P=0.0289), or obstetric causes of FI (P=0.0384). Patients without a history of specific FI treatments (eg, antidiarrheal medications, biofeedback, surgery) were more likely to respond to NASHA/Dx versus sham treatment for both end points.ConclusionAlthough all subgroups analyzed showed evidence of quantitative and qualitative benefit from NASHA/Dx therapy, patients with characteristics indicative of mild-to-moderate FI may exhibit the greatest benefit.

Outcomes of Sacral Neurostimulation Lead Reimplantation for Fecal Incontinence: A Cohort Study.

Adverse events and complications have been reported after sacral neurostimulation for fecal incontinence, which may result in surgical revision and device explantation. Lead reimplantation may be feasible; however, available data regarding outcomes are less robust. The aim of this study was to determine the outcomes of sacral neurostimulation lead reimplantation for fecal incontinence. This was a retrospective review of prospectively collected data. The study was conducted at 2 clinical sites from a single institution. Patients with fecal incontinence who underwent sacral neurostimulation implantation or reimplantation between 2011 and 2014 were included in the study. Sacral neurostimulation reimplantation was the included intervention. Change in the Cleveland Clinic Florida Fecal Incontinence Score (0 best; 20 worst) in reimplantation as compared with index implantation controls was the main measure. Secondary outcomes included the frequency and type of adverse events and complications. A total of 112 patients underwent either sacral neurostimulation implantation or reimplantation between 2011 and 2014. Ninety-seven patients underwent an index percutaneous nerve stimulation trial, 93 of whom also underwent a stimulator implantation. Fifteen patients underwent lead reimplantation, with 5 performed before stimulator implantation and 10 after stimulator implantation. The index implanted and reimplanted groups had similar demographics, comorbidities, and complication profiles including explantation rates. The most common reason for reimplantation was lead related (6/15), including 4 lead migrations, 1 lead fracture, and 1 lead erosion. Significant decreases in the incontinence score were achieved in each group (index implantation: p < 0.001; reimplantation: p = 0.006). When comparing the efficacy of sacral neurostimulation therapy in decreasing the fecal incontinence score from baseline in each group, patients with an index implantation were found to have a more significant improvement in their incontinence score as compared with the reimplantation group (p = 0.047). This was a retrospective study. A large number of patients with incomplete functional assessment data were excluded from analysis. The improvements in fecal incontinence are significantly better after index implantation than after reimplantation.