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Background The efficacy of a single administration of darvadstrocel (expanded allogeneic adipose-derived mesenchymal stem cells) for treating complex perianal fistulas in patients with Crohn’s disease was demonstrated in a randomized, double-blind trial (ADMIRE-CD [Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn\'s Disease] trial). The current chart review study (INSPECT [A retrospectIve chart review study evaluatINg the longer-term effectiveneSs of darvadstrocel in PatiEnts who CompleTed ADMIRE-CD]) evaluated the longer-term effectiveness and safety of darvadstrocel. Methods Eligible patients had completed at least 52 weeks in the ADMIRE-CD trial. Data on clinical remission and fistula relapse outcomes were collected retrospectively at 104 and 156 weeks after treatment. Adverse events of special interest (tumorigenicity and ectopic tissue formation) were collected up to 208 weeks after treatment. Results Eighty-nine patients were included (43 darvadstrocel patients, 46 control subjects). At 52, 104, and 156 weeks posttreatment, clinical remission was observed in 29 (67.4%) of 43, 23 (53.5%) of 43, and 23 (53.5%) of 43 darvadstrocel-treated patients, compared with 24 (52.2%) of 46, 20 (43.5%) of 46, and 21 (45.7%) of 46 control subjects, respectively. In patients with clinical remission at week 52, this remission was sustained at 104 and 156 weeks after treatment in 19 (65.5%) of 29 and 16 (55.2%) of 29 darvadstrocel-treated patients and in 17 (70.8%) of 24 and 13 (54.2%) of 24 control subjects, respectively. Time to fistula relapse and incidence of fistula relapse or new fistula occurrence were not significantly different between groups. Tumorigenicity was reported for 1 (2.2%) patient in the control group (malignant epidermoid carcinoma). No ectopic tissue formation was reported. Conclusions Real-world follow-up of patients from the ADMIRE-CD trial indicates that clinical remission of complex perianal fistulas can be sustained in the long term irrespective of whether it is achieved through darvadstrocel administration or maintenance treatment regimens and confirms a favorable long-term safety profile of darvadstrocel.

Additive manufacturing techniques allow the customized design of medical devices according to the patient’s requirements. Enteroatmospheric fistula is a pathology that benefits from this personalization due to its extensive clinical variability since the size and morphology of the wound differ extensively among patients. Standard prosthetics do not achieve proper isolation of the wound, leading to a higher risk of infections. Currently, no effective personalized technique to isolate it has been described. In this work, we present the workflow for the design and manufacture of customized devices adapted to the fistula characteristics. For each case, a device was designed with dimensions and morphology depending on each patient’s requirements using white light scanning, CAD design, and additive manufacturing. The design and manufacture of the devices were performed in 230.50 min [184.00, 304.75]. After the placement of the device, the wound was successfully isolated from the intestinal content for 48-72h. Negative Pressure Wound Therapy (NPWT) was applied for 27.71 ± 13.74 days, and the device was redesigned to adapt to the wound when geometrical evolutionary changes occur during the therapy. It was observed a decrease in weekly cures from 23.63 ± 10.54 to 2.69 ± 0.65 (p = 0.001). The fistulose size was reduced longitudinal and transversally by 3.25 ± 2.56 cm and 6.06 ± 3.14 cm respectively. The wound depth also decreased by 1.94 ± 1.08 cm. In conclusion, customization through additive manufacturing is feasible and offers promising results in the generation of personalized devices for the treatment of enteroatmospheric fistula.

Background and Aims Management of inflammatory bowel disease [IBD] is complex and IBD Comprehensive Care Units [ICCUs] facilitate the delivery of quality care to IBD patients. The objective of this study was to update the existing set of quality indicators [QIs] for ICCUs, based on a nationwide quality certification programme carried out in Spain, from a multi-stakeholder perspective and using multicriteria decision analysis [MCDA] methodology. Methods An MCDA comprising three different phases was conducted. In phase 1, a systematic literature review was performed, and after validation by a scientific committee comprising 11 experts, a preliminary set of QIs was developed. In phase 2, a larger group of 49 experts determined the relevance and relative importance of each QI by prioritising and weighing the preliminary set. Finally in phase 3, the scientific committee reviewed the results and made a final selection via a deliberative process. Results The final set comprised 67 QIs, classified as Structure [23 QIs], Process [35 QIs] and Outcome [9 QIs], which were ranked according to their relative importance. Multidisciplinary management was the most important requirement in ICCUs, followed by continuity of care, standardisation of clinical care and, especially, the incorporation of patients’ reported outcomes. Conclusions This updated set of QIs comprises a weighted and prioritised set of items that represent the essential minimum of criteria for ensuring appropriate quality of care in the management of IBD patients.

Data from this paper were presented as a poster at the ISCT Europe 2018, Regional Meeting in Florence, Italy, held between 12 and 14 September 2018., [Aim] Management of faecal incontinence (FI) remains challenging because no definitive optimal treatment for this condition has yet been determined. Regenerative medicine could be an attractive therapeutic alternative for treating FI. Here, we aimed to determine the safety and feasibility of autologous expanded mesenchymal stem cells derived from adipose tissue (AdMSCs) in the treatment of patients diagnosed with structural FI., [Method] This was a randomized, multicentre, triple‐blinded, placebo‐controlled pilot study conducted at four sites in Spain with 16 adults with FI and a sphincter defect. Autologous AdMSCs were obtained from patients from surgically excised adipose tissue. These patients were intralesionally infused with a single dose of 4 × 107 AdMSCs or a placebo while under anaesthesia. We assessed the safety and feasibility of the treatment as the cumulative incidence of adverse events and the treatment efficacy using the Cleveland Clinic Faecal Incontinence Score, Faecal Incontinence Quality of Life score and Starck criteria to classify sphincter defects and anorectal physiology outcomes., [Results] Adipose tissue extraction, cell isolation and intralesional infusion procedures were successful in all the patients. There was only one adverse event connected to adipose tissue extraction (a haematoma), and none was associated with the injection procedure. There were no significant differences in any of the assessed clinical, manometric or ultrasonographic parameters., [Conclusion] This study indicates that this infusion procedure in the anal sphincter is feasible and safe. However, it failed to demonstrate efficacy to treat patients with structural FI., This project received partial funding from the Andalusian Ministry of Health (grant number PI‐0424‐2013).

Objective The development and validation of a new version of the fecal incontinence (FI) scale "Rapid Assessment Fecal Incontinence Score" (RAFIS) incorporating domains for severity, type of stool loss, and global perception of the effect of incontinence on quality of life (QoL). Background FI negatively impacts on QoL. Currently used incontinence questionnaires have outstanding limitations on the global assessment of the impact of the disease on QoL that patients perceive. We developed a new version of RAFIS with a more complete questionnaire. Materials and methods A 3-phase study was performed to evaluate the applicability and reliability of our questionnaire as a tool for assessing FI. Our score was completed by 98 patients (78 women; mean age: 57±13 y) who presented with FI and who were referred from 4 colorectal surgery centers. The RAFIS was assessed for internal consistency, test-retest reliability, and sensitivity to change. A multivariate analysis was performed. Comparisons were made with the Wexner Cleveland Clinic Incontinence Score and the Fecal Incontinence Quality of Life Scale. Results The RAFIS showed good internal consistency and test-retest reliability, differentiating the severity of incontinence but not the etiology. There was a moderate-high correlation between the new scale and the reference scales. Sensitivity to change, compared with the Wexner Score, was moderate. Comparison with established QoL instruments showed a moderate negative correlation. Logistic regression of the RAFIS discriminated between mild and moderate-severe impact on QoL. No correlation was detected with the new score to the presence of an anal sphincter defect or sphincter hypotonia. Conclusion The RAFIS scale is easy to administer and compares well with other validated incontinence instruments.

Supplemental Digital Content is available in the text., BACKGROUND: Low anterior resection syndrome is pragmatically defined as disordered bowel function after rectal resection leading to a detriment in quality of life. This broad characterization does not allow for precise estimates of prevalence. The low anterior resection syndrome score was designed as a simple tool for clinical evaluation of low anterior resection syndrome. Although the low anterior resection syndrome score has good clinical utility, it may not capture all important aspects that patients may experience. OBJECTIVE: The aim of this collaboration was to develop an international consensus definition of low anterior resection syndrome that encompasses all aspects of the condition and is informed by all stakeholders. DESIGN: This international patient-provider initiative used an online Delphi survey, regional patient consultation meetings, and an international consensus meeting. PARTICIPANTS: Three expert groups participated: patients, surgeons, and other health professionals from 5 regions (Australasia, Denmark, Spain, Great Britain and Ireland, and North America) and in 3 languages (English, Spanish, and Danish). MAIN OUTCOME MEASURE: The primary outcome measured was the priorities for the definition of low anterior resection syndrome. RESULTS: Three hundred twenty-five participants (156 patients) registered. The response rates for successive rounds of the Delphi survey were 86%, 96%, and 99%. Eighteen priorities emerged from the Delphi survey. Patient consultation and consensus meetings refined these priorities to 8 symptoms and 8 consequences that capture essential aspects of the syndrome. LIMITATIONS: Sampling bias may have been present, in particular, in the patient panel because social media was used extensively in recruitment. There was also dominance of the surgical panel at the final consensus meeting despite attempts to mitigate this. CONCLUSIONS: This is the first definition of low anterior resection syndrome developed with direct input from a large international patient panel. The involvement of patients in all phases has ensured that the definition presented encompasses the vital aspects of the patient experience of low anterior resection syndrome. The novel separation of symptoms and consequences may enable greater sensitivity to detect changes in low anterior resection syndrome over time and with intervention.

This article belongs to the Special Issue Polymeric Scaffolds for Tissue Engineering., Skeletal muscle regeneration is increasingly necessary, which is reflected in the increasing number of studies that are focused on improving the scaffolds used for such regeneration, as well as the incubation protocol. The main objective of this work was to improve the characteristics of polycaprolactone (PCL) scaffolds by incorporating elastin to achieve better cell proliferation and biocompatibility. In addition, two cell incubation protocols (with and without dynamic mechanical stimulation) were evaluated to improve the activity and functionality yields of the regenerated cells. The results indicate that the incorporation of elastin generates aligned and more hydrophilic scaffolds with smaller fiber size. In addition, the mechanical properties of the resulting scaffolds make them adequate for use in both bioreactors and patients. All these characteristics increase the biocompatibility of these systems, generating a better interconnection with the tissue. However, due to the low maturation achieved in biological tests, no differences could be found between the incubation with and without dynamic mechanical stimulation., This work is part of a research project sponsored by MICINN from the Spanish Government (Ref. RTI2018-097100-B-C21).

Surgical treatment of complex anal fistula is challenging, especially when seeking the preservation of the anal sphincters and, subsequently, fecal continence. For this reason, in recent years, a variety of "minimally invasive" techniques have appeared. One of the more popular ones is the use of expanded adipose-derived stem cell (ASCs) injections, which we will demonstrate in the video.

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.

The creation of skeletal muscle tissue in vitro is a major topic of interest today in the field of biomedical research, due to the lack of treatments for muscle loss due to traumatic accidents or disease. For this reason, the intrinsic properties of nanofibrillar structures to promote cell adhesion, proliferation, and cell alignment presents an attractive tool for regenerative medicine to recreate organized tissues such as muscle. Electrospinning is one of the processing techniques often used for the fabrication of these nanofibrous structures and the combination of synthetic and natural polymers is often required to achieve optimal mechanical and physiochemical properties. Here, polycaprolactone (PCL) is selected as a synthetic polymer used for the fabrication of scaffolds, and the effect of protein addition on the final scaffolds' properties is studied. Collagen and gelatin were the proteins selected and two different concentrations were analyzed (2 and 4 wt/vol%). Different PCL/protein systems were prepared, and a structural, mechanical and functional characterization was performed. The influence of fiber alignment on the properties of the final scaffolds was assessed through morphological, mechanical and biological evaluations. A bioreactor was used to promote cell proliferation and differentiation within the scaffolds. The results revealed that protein addition produced a decrease in the fiber size of the membranes, an increase in their hydrophilicity, and a softening of their mechanical properties. The biological study showed the ability of the selected systems to harbor cells, allow their growth and, potentially, develop musculoskeletal tissues., This work is part of a research project sponsored by “Ministerio de Economía y Competitividad” (MINECO/FEDER, EU) from the Spanish Government (Ref. CTQ2015-71164-P).

Presentamos el caso de una mujer de 56 años que presenta salida de heces y gas por la vagina de 6 meses de evolución, refiere flujo vaginal fecaloideo. No refiere síntomas sistémicos ni constitucionales. Presenta una incontinencia fecal de larga evolución con un score de Wexner de 11 que no responde a tratamiento conservador. Ha tenido tres partos y uno de ellos instrumentalizado. Fue intervenida por el servicio de ginecología en Julio del 2015 de un cistocele, rectocele, suspensión ureterovesical con musculo elevador y de una fístula rectovaginal (FRV) con cierre directo en octubre del 2015. En mayo del 2017 presentó una recidiva de la FRV y fue tratada con un Flap endorectal. Como antecedentes personales médicos presenta Hipertensión arterial, Diabetes Mellitus II y Enfermedad psiquiátrica. Se le realizó una colonoscopia de screening de cáncer colorectal hace un año sin datos de patología. A la exploración física presenta a nivel anal un defecto en la cara anterior de los esfínteres anales con un orificio fistuloso de 1cm en tercio medio e inferior de la vagina. Se objetivan restos de heces en vagina. El tono basal esfinteriano, los reflejos anal superficial y de valsalva están disminuidos. No se evidencia descenso del suelo pélvico ni recidiva del rectocele ni del cistocele. En la anorectoscopia se evidencia el orificio fistuloso referido y no se observan signos de proctitis, estenosis ni masas. En la ecografía endoanal presenta un defecto de EAI de más de 180º y del EAE de al menos hasta 180º. Cuerpo perineal de 7mm. Se evidencia la FRV referida. Se descartan colecciones-abscesos perianales.

Aim The aim of the study was to evaluate urgent care practice with regard to anorectal abscesses (AA) in a tertiary-level referral hospital. Materials and methods this was retrospective and unicentric study. Patients who underwent surgery for AA between 2016 and 2017 were included in the study. Demographic variables were analyzed as well as the treatment performed, the need for hospitalization, use of antibiotics, and referral to the coloproctology outpatient department (COD). The recurrence risk factors were also evaluated. Results A total of 220 evaluations under anesthesia were performed, corresponding to 190 patients, 129 males (mean age 46 ± 14.9 years). The most frequent treatment in the emergency department (ED) was simple drainage (75.8%). Antibiotic therapy was prescribed in 62.9% of the cases. A total of 41.1% of the patients were referred to a specialized COD. The only risk factor associated with recurrence was the presence of an associated anal fistula. Conclusions Anorectal abscesses are very frequent in the ED. There is great clinical variability regarding the taking of cultures, prescription of antibiotics, and referral criteria to a specialized coloproctology outpatient department, without clear impact of any of them on the recurrence of the abscess.

Resumen Desde la Asociacion Espanola de Coloproctologia y la Seccion de Coloproctologia de la Asociacion Espanola de Cirujanos se propone un documento de consenso sobre el algoritmo de actuacion en el tratamiento de la fisura anal que pueda ser de utilidad en la toma de decisiones. En el se expone la actualidad en el tratamiento conservador, medico y quirurgico, finalizando con un algoritmo de recomendacion ante una fisura anal. La metodologia utilizada ha sido: creacion de un grupo de expertos, busqueda en PubMed, MEDLINE y Biblioteca Cochrane de las publicaciones de los ultimos 10 anos sobre fisura anal, presentacion en la XXI Reunion Nacional de la Fundacion Asociacion Espanola de Coloproctologia 2017 con votacion de cada conclusion entre los asistentes, y revision por el comite cientifico de la Asociacion Espanola de Coloproctologia.

The Spanish Association of Coloproctology and the Coloproctology Division of the Spanish Association of Surgeons propose this consensus document with a treatment algorithm for anal fissure that could be used for decision making. Non-surgical therapy and surgical treatment of anal fissure are explained, and the recommended algorithm is provided. The methodology used was: creation of a group of experts; search in PubMed, MEDLINE and the Cochrane Library for publications from the last 10 years about anal fissure; presentation at the 21st National Meeting of the Spanish Association of Coloproctology Foundation 2017 with voting for/against each conclusion by the attendees and review by the scientific committee of the Spanish Association of Coloproctology.

Background. Anastomotic dehiscence is a common complication of anterior resection. In this work, we evaluate the management of the pelvic cavity after low rectal resection using vacuum closure (VAC) with a gastroscope, and we establish factors that determine the success of closure and analyzed the rate of ileostomy closure after leakage was resolved. Patients and Methods. This is a descriptive case series analysis conducted at a tertiary hospital. Twenty-two patients with low colorectal anastomosis leakage or opening of the rectal stump after anterior resection for rectal cancer were included. They were treated with VAC therapy. Results. The total number of endoscopic sessions was 3.1 ± 1.9 in the anterior resection with anastomosis group and 3.2 ± 1.8 in the Hartmann group. In 11 patients the therapy was administered in an ambulatory setting. The mean time to healing was 22.3 ± 14.7 days. Full resolution was achieved in 19 patients (followed-up 1 year). Ileostomy closure was carried out in 5 patients (38.46%) during follow-up. None of these patients showed leakage signs. Statistically significant differences were obtained depending on the onset of therapy, with better results in patients who underwent earlier vacuum-assisted therapy (before the sixth week after initial surgery), P = .041. Conclusions. VAC therapy is an alternative to surgery that can be safely administered in an ambulatory setting. Early administration in the 6 weeks following surgery is an independent predictive factor for successful closure; however, colonic transit was only recovered in a small percentage of patients.

Resumen Introduccion Actualmente existe un creciente interes por analizar los resultados de salud en las unidades quirurgicas, implementando estandares de calidad que permitan dilucidar buenas practicas asistenciales. Con este motivo la Asociacion Espanola de Coloproctologia desarrollo un programa de acreditacion de unidades, teniendo en cuenta unos estandares basicos. El objetivo de este articulo es evaluar y analizar los indicadores de calidad especificos del tratamiento quirurgico del cancer colorrectal establecidos en el programa, en varias unidades en proceso de acreditacion. Metodos Se analizaron los datos recogidos de forma prospectiva de la cirugia programada colorrectal en 18 unidades de coloproctologia durante los anos 2013 a 2017. Se consideraron 3 indicadores de calidad principales y 4 secundarios, analizando de forma independiente la cirugia de colon y de recto. Ademas se compararon los resultados segun el abordaje quirurgico. Resultados Se incluyeron para el analisis un total de 3.090 pacientes. La tasa global de fuga anastomotica fue de 7,8% (6,6% colon vs 10,6% en el recto), mientras que la de infeccion de herida quirurgica fue de 12,6% (11,4% colon vs 14,8% en el recto). La mortalidad global a los 30 dias fue de un 2,3%, siendo la relacionada con fuga anastomotica de un 10,2%. Se evidencio una mayor incidencia de infecciones y muertes en los pacientes con abordaje abierto, pero no hubo diferencias en la tasa de dehiscencia con respecto a abordajes minimamente invasivos. Conclusiones Los resultados de este estudio determinan indices de calidad optimos de las unidades acreditadas en el tratamiento del cancer colorrectal, y ademas nos permite establecer referencias realistas en nuestro pais, que ayudaran a una mejor comparacion de resultados.

Introduction Currently, there is growing interest in analyzing the results from surgical units and the implementation of quality standards in order to identify good healthcare practices. Due to this fact, the Spanish Association of Coloproctology (AECP) has developed a unit accreditation program that contemplates basic standards. The aim of this article is to evaluate and analyze the specific quality indicators for the surgical treatment of colorectal cancer, established by the program. Data were collected from colorectal units during the accreditation process. Methods We analyzed prospectively collected data from elective colorectal surgeries at 18 Spanish coloproctology units during the period 2013–2017. Three main and four secondary quality indicators were considered. Colon and rectal surgeries were analyzed independently; furthermore, results were compared according to surgical approach. Results A total of 3090 patients were included in the analysis. The global anastomotic leak rate was 7.8% (6.6% colon vs 10.6% rectum), while the surgical site infection rate was 12.6% (11.4% colon vs 14.8% rectum). Overall 30-day mortality was 2.3%, and anastomotic leak-related mortality was 10.2%. There were higher surgical site infection and mortality rates in the patients operated by open approach, however there was no difference in the anastomotic leak rate when compared with minimally invasive approaches. Conclusions The evaluation of these results has determined optimal quality indices for the units accredited in the treatment of colorectal cancer. Furthermore, it allows us to establish realistic references in our country, thereby providing a better understanding and comparison of outcomes.

Background Multipotent mesenchymal stem cells (MSCs) have been used in inflammatory bowel diseases because of their immunomodulatory and regenerative properties. We investigated their local use in an experimental model of colitis in the rat. Materials and Methods Colitis was induced into 20 Wistar rats with local TNBS instillation. Allogeneic stem cells were derived from rat adipose tissue and labeled with PKH2 linker dye with creation of a control and a second group treated by a local injection into the rectal wall of 2×10⁶ allogeneic adipose tissue-derived stem cells (ADSCs). The thicknesses of different components of the rectum were measured with comparisons made in different parts of the colon of the Hunter inflammatory score. PKH2-dyed ADSCs were detected by fluorescence microscopy. Results and Conclusions Total colitis was induced in 19/20 rats with homing of fluorescent ADSCs. to the crypt base and perivascular space of the submucosa. There were no differences in component rectal wall thicknesses with a higher Hunter score in the treated group compared with the controls, in the rectum (3.8±2.74 vs. 1.5±2.37, respectively; p=0.017) and in right colon (2.5±1.08 vs. 0.20±0.42, respectively; p=0.0001). Local colonic injection of allogeneic adipose stem cells. in experimental colitis is feasible and safe. There is demonstrable homing of cells in chemically-induced colitis both to the treated region and parts of the colon distant to the MSC treatment site. Such cells readily proliferate in vitro and could potentially be a source for future treatment of resistant disease.

Clostridium septicum endophthalmitis is an extremely rare infection with only a few cases reported in the literature. It has an endogenous origin and is associated with gastrointestinal and haematological malignancies. We present the case of a 62-year-old male who presented this infection as the first manifestation of a colon adenocarcinoma.

Resumen Introduccion El dispositivo PICS-AF ™ es un nuevo tapon hecho de colageno que tiene un sistema de retencion en el orificio fistuloso interno. Este estudio piloto ha sido disenado para evaluar la factibilidad y seguridad de este dispositivo en el tratamiento de las fistulas anales criptoglandulares transesfinterianas. Metodos Un total de 44 pacientes (34 hombres) con diagnostico de fistula transesfinteriana fueron incluidos en el estudio, de los cuales 34 fueron seleccionados. Todos los pacientes fueron examinados segun un protocolo estricto antes de la cirugia y hasta 6 meses despues. Se analizaron la factibilidad del procedimiento y los acontecimientos adversos. Resultados El dispositivo se coloco sin incidencias en 30 de los 34 pacientes (factibilidad del 88%). Se evidenciaron un total de 16 acontecimientos adversos, 4 registrados como no relacionados con el procedimiento (3 leves y uno moderado) y 12 relacionados con el procedimiento o el dispositivo implantado. De ellos, 5 fueron leves, 5 moderados y 2 graves. La mayoria de los efectos adversos reportados fueron proctalgia (4 pacientes) o infeccion en el sitio del implante (4 pacientes). Conclusiones El presente estudio indica que el nuevo tapon de colageno puede ser colocado de forma efectiva y con una tasa de complicaciones aceptable.

BACKGROUND AND OBJECTIVE We examined the prognostic value of obesity and nuclear β-catenin in patients with locally advanced rectal cancer. METHODS We prospectively recruited a total of 98 eligible patients with locally advanced cancer for preoperative radiochemotherapy followed by total mesorectal excision. Patients' height and weight were reaorded before radiochemotherapy, and the immunohistochemical expression of nuclear β-catenin was analyzed. Disease-free survival (DFS) was analyzed using the Kaplan-Meier method and a Cox regression model was employed for the multivariate analysis. RESULTS Obese patients were associated with a lower number of recurrences (3.6% vs. 34.3%, P = 0.001), and a higher DFS (95% vs. 53%; HR, 0.09; 95%CI, 0.01-0.64; P = 0.005) than non-obese patients. In the multivariate analysis, body mass index, nuclear β-catenin expression, and the absence of lymph node metastases showed a significant increase in DFS. CONCLUSIONS Obesity and nuclear β-catenin are independent favorable prognostic factors for DFS in locally advanced cancer treated with preoperative radiochemotherapy. J. Surg. Oncol. 2017;115:301-306. © 2017 Wiley Periodicals, Inc.

Currently, hernia treatment involves implantation of a mesh prosthesis, usually made of polypropylene, and the primary complication is infection of the device, which leads to an exponential increase in morbidity. Three‐dimensional printing offers a method of dealing with complications of this magnitude. Therefore, in this study, the bactericidal properties and effectiveness of three‐dimensional‐printed meshes with polycaprolactone (PCL) and gentamicin were evaluated in vitro in Escherichia coli cultures, and their histological behaviour was examined in vivo. Different PCL meshes were implanted into four groups of rats, with 10 rats in each group: PCL meshes, PCL meshes with alginate and calcium chloride, PCL meshes with gentamicin, and PCL meshes with alginate and gentamicin. Thirty‐six microporous meshes were manufactured, and their bactericidal properties were assessed. When the meshes did not include an antibiotic, an inhibition halo was not observed; when the gentamicin was free, an asymmetric inhibition area of 5.65 ± 0.46 cm2 was present; when the gentamicin was encapsulated, a rectangular area of 5.40 ± 0.38 cm2 was observed. In the rats, macroporous and microporous mesh implants produced mild inflammation and substantial fibrosis with collagen and neovascular foci. A significant difference was observed in fibroblastic activity between the PCL with alginate group and the PCL with alginate and gentamicin group microporous meshes (p = .013) and in collagen deposits between the macroporous and microporous meshes in the PCL mesh group (p = .033). The feasibility of manufacturing drug‐doped printed PCL meshes containing alginate and gentamicin was verified, and the meshes exhibited bactericidal effects and good histopathological behaviour.

[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.

[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., A Grant for this work was provided by the Fundación Española de Coloproctología.

Summary Background Complex perianal fistulas in Crohn's disease are challenging to treat. Allogeneic, expanded, adipose-derived stem cells (Cx601) are a promising new therapeutic approach. We aimed to assess the safety and efficacy of Cx601 for treatment-refractory complex perianal fistulas in patients with Crohn's disease. Methods We did this randomised, double-blind, parallel-group, placebo-controlled study at 49 hospitals in seven European countries and Israel from July 6, 2012, to July 27, 2015. Adult patients (≥18 years) with Crohn's disease and treatment-refractory, draining complex perianal fistulas were randomly assigned (1:1) using a pre-established randomisation list to a single intralesional injection of 120 million Cx601 cells or 24 mL saline solution (placebo), with stratification according to concomitant baseline treatment. Treatment was administered by an unmasked surgeon, with a masked gastroenterologist and radiologist assessing the therapeutic effect. The primary endpoint was combined remission at week 24 (ie, clinical assessment of closure of all treated external openings that were draining at baseline, and absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI). Efficacy was assessed in the intention-to-treat (ITT) and modified ITT populations; safety was assessed in the safety population. This study is registered with ClinicalTrials.gov, number NCT01541579. Findings 212 patients were randomly assigned: 107 to Cx601 and 105 to placebo. A significantly greater proportion of patients treated with Cx601 versus placebo achieved combined remission in the ITT (53 of 107 [50%] vs 36 of 105 [34%]; difference 15·2%, 97·5% CI 0·2–30·3; p=0·024) and modified ITT populations (53 of 103 [51%] vs 36 of 101 [36%]; 15·8%, 0·5–31·2; p=0·021). 18 (17%) of 103 patients in the Cx601 group versus 30 (29%) of 103 in the placebo group experienced treatment-related adverse events, the most common of which were anal abscess (six in the Cx601 group vs nine in the placebo group) and proctalgia (five vs nine). Interpretation Cx601 is an effective and safe treatment for complex perianal fistulas in patients with Crohn's disease who did not respond to conventional or biological treatments, or both. Funding TiGenix.

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.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.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).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.

Resumen Introduccion La ecografia endoanal dinamica (EEAD) en 3 dimensiones ha surgido en los ultimos anos como una alternativa a las pruebas existentes en el diagnostico de las alteraciones del suelo pelvico. El objetivo de este trabajo es determinar la utilidad de la ecodefecografia en el diagnostico y evaluacion de los pacientes que presentan sintomas de obstruccion defecatoria, asi como mostrar los resultados obtenidos tras su implementacion en una unidad de suelo pelvico. Metodos Estudio retrospectivo que analiza a 66 pacientes (61 mujeres), con una edad media de 55 anos (19-83). Se realizo una EEAD y se correlaciono con los sintomas y los hallazgos exploratorios en consulta. Se realizo tanto un estudio descriptivo como inferencial, asi como un indice Kappa para buscar correlacion entre la exploracion fisica y la EEAD. Resultados Los motivos de consulta fueron: sindrome de obstruccion defecatoria (SOD) 36 pacientes (54,5%), prolapso de organos pelvicos (POP) 27 pacientes (40,9%) y SOD junto con POP 3 pacientes (4,5%). La correlacion de ambos grupos indica que la EEAD diagnostica mas pacientes con rectocele grado III , enteroceles y anismos que la combinacion de exploracion-manometria-proctoscopia-ecografia 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 Conclusion La ecografia dinamica puede tener un papel relevante como prueba complementaria en el paciente con enfermedad del suelo pelvico, ya que permite diagnosticar procesos que mediante la inspeccion, la exploracion fisica y la manometria pasarian desapercibidos.

Side-to-side intestinal anastomosis is a surgical procedure where an incision is performed between two parallel segments of gut and then they are sutured together. The purpose of this paper is to investigate if the standard surgical practice diameter used in anastomosis leads to undesirable closed circulatory flows which may be harmful to the gut tissue. A finite element model for the chyme flow in a side by side anastomosis with realistic user config urable parameters is developed and solved in a wide range of situations. We analyze the flow crossing the anastomo sis, the normalized pressure difference in the gut section and the streamlines that show the presence or absence of closed flow regions for a set of surgically feasible anasto mosis diameter values. In contrast with the findings of simpler analytical models, closed flows do not appear in any of these cases. The study shows that the current stan dard surgical practice where the anastomosis diameter is similar to the gut diameter does not lead to undesirable effects predicted by some simple analytical models.

There is an increasing recognition of the importance of internal anal sphincter (IAS) dysfunction presenting as passive faecal incontinence. This problem may manifest after anal sphincterotomy or following the more minimally invasive operations for haemorrhoids, as well as with advancing age. Because of the poor results of IAS plication and the beneficial outcomes with peri-urethral bulking agents in urology, these materials have been developed for use in IAS dysfunction. This review outlines the basic purported mechanisms of action, defining the materials in clinical use, their methods of deployment, complications and reported outcomes. There is still much that is unknown concerning the ideal agent or the volume and the technique of deployment, which will only be answered by powerful, prospective, randomized, controlled trials. The specific role of autologous stem cells designed to regenerate the sphincters in cases of functional impairment or muscle loss is yet to be seen.

Genomic characterization of cell-free circulating tumour DNA (ctDNA) may offer an opportunity to assess clonal dynamics throughout the course of a patient's illness. The existence of KRAS driver mutations in colon cancer patients is determinant to decide their treatment and to predict their outcome. DNA is extracted automatically from 400 μL of serum using the MagNa Pure Compact with the Nucleic Acid Isolation Kit I. DNA amplification, COLD-PCR and HRM were performed in the same run in the Light Cycler 480.We found three different situations: pre- and post-surgical samples grouped with the negative control, pre-surgical samples appear to group with the positive control and the post-surgical samples appear to group with the negative control and finally both samples, pre- and post-surgical ones, appear to be grouped with the positive control. COLD-PCR HRM is a cost-effective way for screening one of the most common driver mutations to predict the worst prognosis in colorectal cancer.