Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.

Navigating surgical anatomy of the Denonvilliers' fascia and dissection planes of the anterior mesorectum with a cadaveric simulation model.

Anterior dissection of the rectum in the male pelvis represents one of the most complex phases of total meso-rectal excision. However, the possible existence of different anatomical planes is controversial and the exact anatomical topography of Denonvilliers' fascia is still debated. The aim of the study is to accurately define in a cadaveric simulation model the existence and boundaries of Denonvilliers' fascia, identifying the anatomical planes suitable for surgical dissection. The pelvises of 31 formalin-preserved male cadavers were dissected. Careful and detailed dissection was carried out to visualize the anatomical structures and the potential dissection planes, simulating an anterior meso-rectum dissection. Denonvilliers' fascia was identified in 100% of the pelvises, as a single-layer fascia that originates from the peritoneal reflection and descends until its firm adhesion to the prostate capsule. The fascia divides the space providing an anterior and a posterior plane. Anteriorly to the fascia, during the caudal dissection, its firm adhesion to the prostate capsule forces to section it sharply. The cadaveric simulation model allowed an accurate description of Denonvilliers' fascia, defining several planes for anterior dissection of the meso-rectum.

Técnicas novedosas en el tratamiento de la incontinencia anal / Novel techniques in the treatment of anal incontinence

La incontinencia fecal es un problema que puede condicionar la vida sociolaboral del paciente. Hasta hace poco, la mayoría de enfermos con incontinencia anal grave, en los que habían fracasado medidas conservadoras y/o quirúrgicas, eran sometidos a una colostomía. Actualmente, estos pacientes pueden beneficiarse de alguna técnica innovadora de reciente aparición. Así, disponemos del esfínter anal artificial y de la graciloplastia dinámica, cada una con sus indicaciones específicas. Ambos procedimientos consiguen buenos resultados funcionales, pero con cifras de complicaciones no despreciables y con reintervenciones en bastantes ocasiones. La neuromodulación sacra ha supuesto un avance importante por su relativa sencillez y porque permite, mediante un test de estimulación temporal, discriminar qué pacientes se beneficiarán definitivamente de su aplicación. Otras técnicas, como la inyección de agentes aumentadores de volumen o la radiofrecuencia, son tan recientes y hay tan poca experiencia que su papel todavía está por definir. Al ser tan novedosas las técnicas descritas, además de su elevado coste económico, conviene utilizarlas en grupos de estudio que dispongan de laboratorio de fisiología anorrectal y dentro de ensayos clínicos, hasta que la experiencia demuestre que puede generalizarse, o no, su aplicación (AU)

Fecal incontinence can negatively affect the patient's occupational and social life. Until recently, most patients with severe anal incontinence unresponsive to conservative medical and/or surgical treatments underwent colostomy. Currently, these patients can benefit from one of the innovative techniques that have recently been developed. Thus, the artificial anal sphincter and dynamic graciloplasty are now available, each with specific indications. Both procedures achieve good functional results but complication and reintervention rates are not inconsiderable. Sacral neuromodulation represents an important advance due to its relative simplicity and because, through a period of test stimulation, patients who can definitively benefit from its application can be identified. Other techniques, such as injectable bulking agents or radiofrequency ablation are so recent that experience is limited and their role remains to be defined. Since these techniques are so novel and their economic cost is high, their use should be restricted to study groups with an anorectal physiology laboratory and within the context of clinical trials until experience shows whether or not their application can become widespread (AU)

Defecación obstructiva. Métodos diagnósticos y tratamiento / Obstructive defecation. Diagnostic methods and treatment

La existencia de defecación obstructiva se observa en torno a la mitad de los pacientes con estreñimiento funcional. Se ha relacionado el estreñimiento funcional con alteraciones de la motilidad intestinal (estreñimiento de tránsito lento) y con disfunciones en el suelo pelviano que provocan defecación obstructiva, asociado a una alteración anatómica del suelo pelviano (rectocele, hernia perineal posterior, enterocele y sigmoidocele, intususcepción interna rectal, prolapso mucoso oculto, úlcera rectal solitaria y síndrome del periné descendente) o defecación obstructiva sin existencia de alteración anatómica (disinergia del suelo pelviano o anismo). Se analizan los métodos diagnósticos empleados (anamnesis y exploración física, tiempo de tránsito cólico, test de expulsión de balón, estudios proctográficos, manometría anorrectal y electromiografía), así como el tratamiento médico conservador y las indicaciones y los resultados del tratamiento quirúrgico (AU)

Obstructive defecation is observed in approximately half of all patients with functional constipation. Functional constipation has been related to alterations in intestinal motility (slow transit constipation) and to pelvic floor disorders leading to obstructive defecation associated with anatomical alterations of the pelvic floor (rectocele, posterior perineal hernia, enterocele and sigmoidocele, internal rectal intussusception, occult mucosal prolapse, solitary rectal ulcer and descending perineum syndrome), or obstructive defecation without anatomical alterations (pelvic floor dyssynergy or anismus). The diagnostic methods used (history and physical examination, colonic transit time, balloon expulsion test, proctography, anorectal manometry and electromyography) are reviewed. Conservative medical treatment and the indications for surgical treatment and its results are also discussed (AU)

[Novel techniques in the treatment of anal incontinence]. / Técnicas novedosas en el tratamiento de la incontinencia anal.

Fecal incontinence can negatively affect the patient's occupational and social life. Until recently, most patients with severe anal incontinence unresponsive to conservative medical and/or surgical treatments underwent colostomy. Currently, these patients can benefit from one of the innovative techniques that have recently been developed. Thus, the artificial anal sphincter and dynamic graciloplasty are now available, each with specific indications. Both procedures achieve good functional results but complication and reintervention rates are not inconsiderable. Sacral neuromodulation represents an important advance due to its relative simplicity and because, through a period of test stimulation, patients who can definitively benefit from its application can be identified. Other techniques, such as injectable bulking agents or radiofrequency ablation are so recent that experience is limited and their role remains to be defined. Since these techniques are so novel and their economic cost is high, their use should be restricted to study groups with an anorectal physiology laboratory and within the context of clinical trials until experience shows whether or not their application can become widespread.

[Obstructive defecation. Diagnostic methods and treatment]. / Defecación obstructiva. Métodos diagnósticos y tratamiento.

Obstructive defecation is observed in approximately half of all patients with functional constipation. Functional constipation has been related to alterations in intestinal motility (slow transit constipation) and to pelvic floor disorders leading to obstructive defecation associated with anatomical alterations of the pelvic floor (rectocele, posterior perineal hernia, enterocele and sigmoidocele, internal rectal intussusception, occult mucosal prolapse, solitary rectal ulcer and descending perineum syndrome), or obstructive defecation without anatomical alterations (pelvic floor dyssynergy or anismus). The diagnostic methods used (history and physical examination, colonic transit time, balloon expulsion test, proctography, anorectal manometry and electromyography) are reviewed. Conservative medical treatment and the indications for surgical treatment and its results are also discussed.