Comparative Study of Diluted Hydrogen Peroxide and Sulfur Hexafluoride in the Contrast-Enhanced Ultrasound Assessment of Anal Fistulas.

BACKGROUND: Endoanal ultrasound for the diagnosis of anal fistulas requires the injection of hydrogen peroxide, but it is often uncomfortable for the patient and possesses potential complications. Novel ultrasound contrast is currently available. OBJECTIVE: We aimed to assess the efficacy and safety of sulfur hexafluoride as an ultrasound contrast agent for the diagnosis of perianal fistula by comparing it with those of 50% diluted hydrogen peroxide. DESIGN: Double-blind superiority study with 4 consecutive visits to perform an ultrasound without contrast, a hydrogen peroxide-enhanced ultrasound, a sulfur hexafluoride-enhanced ultrasound and a rectal exploration in the operating room (the gold standard). The ultrasound images were independently reviewed by three expert surgeon sonographers. CLINICAL SETTING: This study was conducted at a single university hospital. PATIENTS: Data from 176 patients were evaluated. PRIMARY OUTCOME MEASURES: Demographic and exploratory data and the ultrasound findings related to the location of the internal fistula orifice, description of the primary and secondary tracts, and presence of cavities and sphincter defects were analyzed. The complications occurring before and after the contrast agent administration and the presence of pain measured using a score were considered. RESULTS: Eighty-eight patients were included (men: 71.5%; mean age: 48.3 years).62.5% had a complex type and 83.7% had a transsphincteric type. Sulfur hexafluoride-enhanced ultrasounds demonstrated a higher interobserver agreement in determining the secondary tracts (κ= 0.604) and anal fistula height (κ=0.604) compared with other methods. Both hydrogen peroxide-enhanced ultrasound (90.91%) and sulfur hexafluoride-enhanced ultrasound (89.77%) detected the internal orifice more frequently than ultrasounds without contrast (62.5%) (p < 0.001),with no differences between contrast agents (p = 0.810). Sulfur hexafluoride-enhanced ultrasound were less painful than peroxide-enhanced ultrasound (p < 0.001). LIMITATIONS: Most of the patients had transsphincteric anal fistulas. CONCLUSIONS: Sulfur hexafluoride proved comparable to hydrogen peroxide in evaluating fistulous tracts and identifying the internal orifice and additionally reduced significantly pain and discomfort. Furthermore, demonstrated a higher interobserver agreement in determining the secondary tracts and anal fistula height compared with other methods. See Video Abstract.

Efficacy of Sacral Nerve Stimulation in Non-constipated Irritable Bowel Syndrome Patients: A Systematic Review.

BACKGROUND AND AIMS: Irritable bowel syndrome (IBS) is a prevalent disorder with a complex and heterogeneous physiopathology, including a dysregulation of gut-brain axis. Treatment for IBS is targeted to the predominant symptom and requires a multidisciplinary approach. This review aims to evaluate the efficacy and safety of sacral nerve stimulation in non-constipated IBS patients Methods: A literature search was carried out on MEDLINE, The Cochrane Central Register of Controlled Trials (CENTRAL) and Web of Science databases for all relevant articles. Quality of included papers was assessed using standardized guidelines Results: Of 129 initial citations, 7 articles met our predefined inclusion criteria, including five randomized trials, a pilot study and a descriptive follow-up study. Five of 7 studies reported a positive effect of sacral nerve stimulation on symptoms and quality of life improvement in non-constipated IBS patients. No study reported serious adverse events. CONCLUSIONS: Despite initial promising results of sacral nerve stimulation in non-constipated IBS patients, studies with larger sample sizes and longer follow-up are required.

Feasibility and safety of calcium alginate hydrogel sealant for the treatment of cryptoglandular fistula-in-ano: phase I/IIa clinical trial.

AIM: Complex perianal fistulas pose a challenge to the surgeon since the fistulous tract must be eliminated without impairing continence. Although without strong scientific evidence, some bibliography has demonstrated the efficacy of some sealants in the treatment of anal fistulas. We aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the fistulous tract as treatment for trans-sphincteric cryptoglandular fistulas. METHODS: A prospective, single-centre, case series of this novel technique was conducted in a level 3 Spanish hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. A strict follow-up was performed by an independent surgeon at 1, 3, 6 and 12 months. The main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment. RESULTS: Twenty patients were treated. The treatment was performed for all patients. Seven adverse events related to the injection product or the surgical procedure were identified. After a 12-month follow-up, 12 patients were completely cured and eight were not cured, with a greater response in the first 6 months. These findings were confirmed by endoanal ultrasound, with a Cohen's kappa concordance rate of 0.89. No statistically significant differences were observed in pain measured using the visual analogue scale, faecal incontinence measured using the Wexner scoring system, and quality of life analysed by the SF-36 Health Survey. CONCLUSION: The treatment was feasible, safe and with discrete satisfactory healing results. It also demonstrated an acceptable safety profile, without worsening of faecal incontinence, quality of life and pain following treatment.

Influence of robotics in surgical complication rate in elderly population with rectal cancer.

BACKGROUND: Rectal cancer surgery is a technically complex procedure. Moreover, short-term outcomes show high rate of complications especially in elderly and laparoscopic surgery has not demonstrated to be able to reduce this complication rate. Robotics has several advantages in pelvic surgical procedures, which could have an impact in complication rates in elderly patients. AIMS: The aim of our study is to demonstrate whether robotic surgery has any influence on the reduction of complications in the aged population undergoing rectal cancer. METHODS: We performed a retrospective analysis of a prospective database of 151 patients who underwent robotic surgery for rectal cancer. We divided our population into three groups: under 65-year-old, between 65- and 80-year-old and above 80-year-old. We recorded complications in each group intra and post procedure. RESULTS: The present study included 151 patients (94 males). Of them, 77 patients were under 66 year old, 63 patients were between 66 and 79 year old and 11 patients were 80 year old and above. The analysis showed conversion rates of 10.38%, 13.69%, 27.27%, and the complication rate of 23.4%, 23.8%, and 27.3% in each group. Univariate analysis showed no differences between the three groups. Nevertheless, there were statistical differences from BMI, ASA and neoadjuvant therapy. In multivariant analysis only neoadjuvant therapy was significant. CONCLUSIONS: Robotic approach does not decrease complications in elderly population and conversion is similar in these age groups. So we should not rule out robotic surgery in elderly patients, although we must select each case with a multidisciplinary approach.

Platelet-rich plasma (PRP) versus fibrin glue in cryptogenic fistula-in-ano: a phase III single-center, randomized, double-blind trial.

PURPOSE: To compare the clinical outcome of autologous platelet-rich growth factor (PRP) with commercial fibrin glue in the management of high cryptogenic fistulae-in-ano. METHOD: The study was conducted at a single center between July 2012 and July 2015 and performed as a phase III, randomized, double-blind comparison of autologously prepared PRP versus fibrin glue for cryptoglandular anal fistulae without active sepsis. Patients were assessed with clinical and endosonographic follow-up. Patients were followed up at 1 week and then at 3, 6, and 12 postoperative months. The primary outcome measure was the fistula healing rate (complete, partial, and non-healing) with secondary outcome measures assessing fistula recurrence, continence status, quality of life, and visual analog pain scores. RESULTS: Of the 56 enrolled patients, 32 were PRP-treated and 24 were fibrin-treated. The groups were well matched for fistula type with an improved overall healing rate for PRP-treated over fibrin-treated cases (71% vs. 58.3%, respectively; P = 0.608); a complete healing rate of 48.4% vs. 41.7%, respectively; and a partial healing rate of 22.6% vs. 16.7%, respectively. The median pain scores of PRP-treated patients were lower at the first visit with a greater initial pain decrease early during follow-up. Improvements in pain reduction impacted the quality of life measures (P = 0.035). All adverse events were minor and no patient experienced a negative impact on continence. CONCLUSION: Treatment of complex cryptoglandular anal fistula with autologous PRP is as effective as fibrin glue with less cost and no adverse effect on continence.

Incontinencia fecal en el paciente anciano. Revisión de conjunto / Fecal incontinence in older patients. A narrative review

La incontinencia fecal representa una de las principales causas de institucionalización en las últimas décadas de la vida de una persona, asociando además gran repercusión psicosocial y económica. La literatura muestra escasa evidencia cuando se trata de analizar de forma específica a este grupo de población, debido a la falta de uniformidad en la consideración de «paciente anciano» y en la dificultad de su detección y diagnóstico. El objetivo de este artículo ha sido realizar una revisión narrativa de los principales aspectos relacionados con la incontinencia fecal en el anciano y facilitar el manejo de estos pacientes. La asistencia para la defecación, las modificaciones dietéticas y el control de la consistencia de las deposiciones o el tratamiento farmacológico son en muchos casos medidas suficientes. No obstante, otras terapias como el biofeedback, la neuromodulación o el tratamiento quirúrgico no deben descartarse y han de ser valoradas de forma selectiva en pacientes ancianos

Fecal incontinence is one of the leading causes for the institutionalization of people in the last decades of life, associated with a great psychosocial and economic burden. The literature is scarce in this population group, due to the absence of universally accepted criteria to define "elderly patients" and difficulties in detection and diagnostic. The aim of this article was to conduct a narrative review of the main aspects related to fecal incontinence in older patients, providing management support. Toileting assistance, dietary change, controlling stool consistency and medical treatment can be used to treat these patients. Nevertheless, other therapies, such as biofeedback, neuromodulation or surgical treatment, can be considered in selected patients

Fecal incontinence in older patients. A narrative review. / Incontinencia fecal en el paciente anciano. Revisión de conjunto.

Fecal incontinence is one of the leading causes for the institutionalization of people in the last decades of life, associated with a great psychosocial and economic burden. The literature is scarce in this population group, due to the absence of universally accepted criteria to define "elderly patients" and difficulties in detection and diagnostic. The aim of this article was to conduct a narrative review of the main aspects related to fecal incontinence in older patients, providing management support. Toileting assistance, dietary change, controlling stool consistency and medical treatment can be used to treat these patients. Nevertheless, other therapies, such as biofeedback, neuromodulation or surgical treatment, can be considered in selected patients.

Factibility and security study of the PICS-AF™ plug for the treatment of cryptoglandular anal fistula. / Estudio de factibilidad y seguridad del plug de colágeno (PICS-AF™) en el tratamiento de la fístula anal criptoglandular.

INTRODUCTION: The PICS-AF™ (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fístulas. METHODS: A total of 44 patients (34 men), with a mean age of 54.68±7.3, with trans-sphincteric anal fístulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed. RESULTS: Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5were mild, 5moderate and 2severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients). CONCLUSIONS: The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate.

Estudio de factibilidad y seguridad del plug de colágeno (PICS-AF(TM)) en el tratamiento de la fístula anal criptoglandular / Factibility and security study of the PICS-AF(TM) plug for the treatment of cryptoglandular anal fistula

INTRODUCCIÓN: El dispositivo PICS-AF(TM) es un nuevo tapón hecho de colágeno que tiene un sistema de retención en el orificio fistuloso interno. Este estudio piloto ha sido diseñado para evaluar la factibilidad y seguridad de este dispositivo en el tratamiento de las fístulas anales criptoglandulares transesfinterianas. MÉTODOS: Un total de 44 pacientes (34 hombres) con diagnóstico de fístula transesfinteriana fueron incluidos en el estudio, de los cuales 34 fueron seleccionados. Todos los pacientes fueron examinados según un protocolo estricto antes de la cirugía y hasta 6 meses después. Se analizaron la factibilidad del procedimiento y los acontecimientos adversos. RESULTADOS: El dispositivo se colocó sin incidencias en 30 de los 34 pacientes (factibilidad del 88%). Se evidenciaron un total de 16 acontecimientos adversos, 4registrados como no relacionados con el procedimiento (3 leves y uno moderado) y 12 relacionados con el procedimiento o el dispositivo implantado. De ellos, 5fueron leves, 5moderados y 2graves. La mayoría de los efectos adversos reportados fueron proctalgia (4 pacientes) o infección en el sitio del implante (4 pacientes). CONCLUSIONES: El presente estudio indica que el nuevo tapón de colágeno puede ser colocado de forma efectiva y con una tasa de complicaciones aceptable

INTRODUCTION: The PICS-AF(TM) (Curaseal Inc.) device is a new plug made of collagen that has a retention system in the internal orifice. This pilot study was designed to assess both the feasibility and safety of this plug in the treatment of trans-sphincteric anal fístulas. METHODS: A total of 44 patients (34 men), with a mean age of 54.68±7.3, with trans-sphincteric anal fístulas were included in the study; 34 of them were analyzed. All patients were examined according to a strict preoperative protocol and until 6 months after surgery. The feasibility of the procedure and the adverse events were analyzed. RESULTS: Finally, 34 patients were operated on, and in 30 of them the plug was used. Therefore, the feasibility was calculated at 88%. There was a total of 16 adverse events, 4recorded as not related (3 mild and one moderate) and 12 related to the procedure or to the device implanted. Of these, 5were mild, 5moderate and 2severe. The majority of the events reported were related to proctalgia (4 patients) or infection at the implant site (4 patients). CONCLUSIONS: The present study indicates that the new collagen plug can be placed effectively and with an acceptable complication rate

Learning curve in robotic rectal cancer surgery: current state of affairs.

INTRODUCTION: Robotic-assisted rectal cancer surgery offers multiple advantages for surgeons, and it seems to yield the same clinical outcomes as regards the short-time follow-up of patients compared to conventional laparoscopy. This surgical approach emerges as a technique aiming at overcoming the limitations posed by rectal cancer and other surgical fields of difficult access, in order to obtain better outcomes and a shorter learning curve. MATERIAL AND METHODS: A systematic review of the literature of robot-assisted rectal surgery was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The search was conducted in October 2015 in PubMed, MEDLINE and the Cochrane Central Register of Controlled Trials, for articles published in the last 10 years and pertaining the learning curve of robotic surgery for colorectal cancer. It consisted of the following key words: "rectal cancer/learning curve/robotic-assisted laparoscopic surgery". RESULTS: A total of 34 references were identified, but only 9 full texts specifically addressed the analysis of the learning curve in robot-assisted rectal cancer surgery, 7 were case series and 2 were non-randomised case-comparison series. Eight papers used the cumulative sum (CUSUM) method, and only one author divided the series into two groups to compare both. The mean number of cases for phase I of the learning curve was calculated to be 29.7 patients; phase II corresponds to a mean number 37.4 patients. The mean number of cases required for the surgeon to be classed as an expert in robotic surgery was calculated to be 39 patients. CONCLUSION: Robotic advantages could have an impact on learning curve for rectal cancer and lower the number of cases that are necessary for rectal resections.

Utilidad de la ecografía dinámica tridimensional en el estudio del suelo pélvico / The role of tridimensional dynamic ultrasound for pelvic floor evaluation

INTRODUCCIÓN: La ecografía endoanal dinámica (EEAD) en 3 dimensiones ha surgido en los últimos años como una alternativa a las pruebas existentes en el diagnóstico de las alteraciones del suelo pélvico. El objetivo de este trabajo es determinar la utilidad de la ecodefecografía en el diagnóstico y evaluación de los pacientes que presentan síntomas de obstrucción defecatoria, así como mostrar los resultados obtenidos tras su implementación en una unidad de suelo pélvico. MÉTODOS: Estudio retrospectivo que analiza a 66 pacientes (61 mujeres), con una edad media de 55 años (19-83). Se realizó una EEAD y se correlacionó con los síntomas y los hallazgos exploratorios en consulta. Se realizó tanto un estudio descriptivo como inferencial, así como un índice Kappa para buscar correlación entre la exploración física y la EEAD. RESULTADOS: Los motivos de consulta fueron: síndrome de obstrucción defecatoria (SOD) 36 pacientes (54,5%), prolapso de órganos pélvicos (POP) 27 pacientes (40,9%) y SOD junto con POP 3 pacientes (4,5%). La correlación de ambos grupos indica que la EEAD diagnostica más pacientes con rectocele grado III, enteroceles y anismos que la combinación de exploración-manometría-proctoscopia-ecografía bidimensional (Kappa 0,26; 0,38 y 0,21; IC 95%: 0,07-1,00; 0,15-1,00 y 0,12-1,00, respectivamente) (p < 0,001). Por el contrario, la EEAD diagnostica menos descensos del periné (Kappa 0,28; IC 95% 0,12-1,00). CONCLUSIÓN: La ecografía dinámica puede tener un papel relevante como prueba complementaria en el paciente con enfermedad del suelo pélvico, ya que permite diagnosticar procesos que mediante la inspección, la exploración física y la manometría pasarían desapercibidos

INTRODUCTION: Dynamic endoanal ultrasound has emerged in recent years as a test that could replace the now existing tests in the diagnosis of pelvic floor disorders. The aim of this paper is to determine the usefulness of echodefecography in the diagnosis and evaluation of patients with symptoms of anorrectal obstruction, and show the results obtained after its implementation in a pelvic floor unit, as a complementary tool that could replace conventional defecography. METHODS: In this retrospective study we analyzed 66 patients with a mean age of 55 years (19-83), 61 women (92%). All dynamic ultrasound was performed in 3 dimensions and was correlated with symptoms and physical findings in the consultation. A descriptive and inferential study was performed to find a kappa correlation between physical examination and echodefecography. RESULTS: The reasons for consultation were: Anorrectal obstruction syndrome 36 patients (54.5%), pelvic organ prolapse 27 patients (40.9%), and anorrectal obstruction syndrome along with pelvic organ prolapse 3 patients (4.5%). The correlation of the 2 groups indicated that echodefecography diagnosed more patients with grade III rectocele, enteroceles, and anismus than the combination of scan-ultrasound-manometry-proctoscopy (Kappa 0.26, 0.38 and 0.21, 95% CI: from 0,07 to 1.00, 0.15 to 1.00 and from 0.12 to 1.00, respectively) (P<.001). Conversely, echodefecography diagnosed less perineal descense (Kappa 0.28, 95% CI: 0.12 to 1.00). CONCLUSIONS: Dynamic anal ultrasonography may have a role as a complementary test in patients with pelvic floor disorders, achieving diagnoses that would go undetected by inspection, physical examination and manometry

The role of tridimensional dynamic ultrasound for pelvic floor evaluation.

INTRODUCTION: Dynamic endoanal ultrasound has emerged in recent years as a test that could replace the now existing tests in the diagnosis of pelvic floor disorders. The aim of this paper is to determine the usefulness of echodefecography in the diagnosis and evaluation of patients with symptoms of anorrectal obstruction, and show the results obtained after its implementation in a pelvic floor unit, as a complementary tool that could replace conventional defecography. METHODS: In this retrospective study we analyzed 66 patients with a mean age of 55 years (19-83), 61 women (92%). All dynamic ultrasound was performed in 3 dimensions and was correlated with symptoms and physical findings in the consultation. A descriptive and inferential study was performed to find a kappa correlation between physical examination and echodefecography. RESULTS: The reasons for consultation were: Anorrectal obstruction syndrome 36 patients (54.5%), pelvic organ prolapse 27 patients (40.9%), and anorrectal obstruction syndrome along with pelvic organ prolapse 3 patients (4.5%). The correlation of the 2 groups indicated that echodefecography diagnosed more patients with grade III rectocele, enteroceles, and anismus than the combination of scan-ultrasound-manometry-proctoscopy (Kappa 0.26, 0.38 and 0.21, 95% CI: from 0,07 to 1.00, 0.15 to 1.00 and from 0.12 to 1.00, respectively) (P<.001). Conversely, echodefecography diagnosed less perineal descense (Kappa 0.28, 95% CI: 0.12 to 1.00). CONCLUSIONS: Dynamic anal ultrasonography may have a role as a complementary test in patients with pelvic floor disorders, achieving diagnoses that would go undetected by inspection, physical examination and manometry.