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.

Profilaxis de la hernia paraestomal mediante malla de polipropileno en espacio preperitoneal / Prevention of parastomal hernia with a preperitoneal polypropelene mesh

OBJETIVO: Presentar nuestra experiencia en la implantación periestomal de malla de polipropileno en espacio preperitoneal como profilaxis de hernia paraestomal en colostomías terminales en pacientes intervenidos por neoplasia rectal. MÉTODOS: Desde enero de 2010 hasta marzo de 2014, 45 pacientes consecutivos afectados de neoplasia de recto que requirieron implantación de colostomía terminal definitiva fueron intervenidos y analizados. En todos ellos se implantó una malla de polipropileno profiláctica en espacio preperitoneal periestomal. Analizamos variables demográficas, aspectos técnicos y efectividad de la técnica así como complicaciones consecuentes. RESULTADOS: Se implantó malla profiláctica en 45 pacientes, 35 varones y 10 mujeres, con una media edad de 66,2 años (47-88) y un indice de masa corporal de 29,1 (20,4-40,6). Se intervinieron de manera programada y con idéntico protocolo 7 adenocarcinomas de recto medio, 36 de recto bajo, un melanoma de recto y un carcinoma de células escamosas de ano; realizándose una amputación abdominoperineal en 38 pacientes y resección anterior baja con colostomía terminal en 7 pacientes. La vía de abordaje fue laparotómica en 39 casos y laparoscópica en 6 casos, 2 de los cuales se convirtieron a laparotomía. La mediana del tiempo de seguimiento fue de 22 meses (2,1-53). Se evidenciaron 3 hernias paraestomales (6,6%), siendo un hallazgo radiológico durante tomografía computarizada de control. No hubo complicaciones asociadas a la colostomía ni a la implantación de la malla. CONCLUSIONES: La colocación de una malla de polipropileno en localización paraestomal preperitoneal es fácilmente reproducible, disminuyendo la incidencia de hernia paraestomal sin aumentar la morbilidad ni la mortalidad

OBJECTIVE: To show our results with the use of a polypropylene mesh at the stoma site, as prophylaxis of parastomal hernias in patients with rectal cancer when a terminal colostomy is performed. METHODS: From January 2010 until March 2014, 45 consecutive patients with rectal cancer, underwent surgical treatment with the need of a terminal colostomy. A prophylactic mesh was placed in a sublay position at the stoma site in all cases. We analyze Demographics, technical issues and effectiveness of the procedure, as well as subsequent complications. RESULTS: A prophylactic mesh was placed in 45 patients, 35 male and 10 females, mean age of 66.2 (47-88) and Body Mass Index 29.19 (20.4-40.6). A total of 7 middle rectal carcinoma, 36 low rectal carcinoma, one rectal melanoma and one squamous cell anal carcinoma were electively treated with identical protocol. Abdominoperineal resection was performed in 38 patients, and low anterior resection with terminal colostomy in 7. An open approach was elected in 39 patients and laparoscopy in 6, with 2 conversions to open surgery. Medium follow up was 22 months (2.1-53). Overall, 3 parastomal hernias (6.66%) were found, one of which was a radiological finding with no clinical significance. No complications related to the mesh or the colostomy were found. CONCLUSIONS: The use of a prophylactic polypropylene mesh placed in a sublay position at the stoma site is a safe and feasible technique. It lowers the incidence of parastomal hernias with no increased morbidity

Prevention of parastomal hernia with a preperitoneal polypropelene mesh.

OBJECTIVE: To show our results with the use of a polypropylene mesh at the stoma site, as prophylaxis of parastomal hernias in patients with rectal cancer when a terminal colostomy is performed. METHODS: From January 2010 until March 2014, 45 consecutive patients with rectal cancer, underwent surgical treatment with the need of a terminal colostomy. A prophylactic mesh was placed in a sublay position at the stoma site in all cases. We analyze Demographics, technical issues and effectiveness of the procedure, as well as subsequent complications. RESULTS: A prophylactic mesh was placed in 45 patients, 35 male and 10 females, mean age of 66.2 (47-88) and Body Mass Index 29.19 (20.4-40.6). A total of 7 middle rectal carcinoma, 36 low rectal carcinoma, one rectal melanoma and one squamous cell anal carcinoma were electively treated with identical protocol. Abdominoperineal resection was performed in 38 patients, and low anterior resection with terminal colostomy in 7. An open approach was elected in 39 patients and laparoscopy in 6, with 2 conversions to open surgery. Medium follow up was 22 months (2.1-53). Overall, 3 parastomal hernias (6.66%) were found, one of which was a radiological finding with no clinical significance. No complications related to the mesh or the colostomy were found. CONCLUSIONS: The use of a prophylactic polypropylene mesh placed in a sublay position at the stoma site is a safe and feasible technique. It lowers the incidence of parastomal hernias with no increased morbidity.

Evolución del abordaje quirúrgico de la colecistitis aguda en una unidad de cirugía de urgencias / Development of the surgical approach to acute cholecystitis in an emergency surgical unit

Objetivo La aplicación de la técnica laparoscópica en la colecistitis aguda es aún hoy un tema controvertido. El objetivo del estudio es valorar la aplicabilidad, seguridad, beneficios y complicaciones del abordaje laparoscópico en pacientes con colecistitis aguda, así como la evolución y desarrollo de dicha vía en la unidad de cirugía de urgencias de un hospital de tercer nivel, en comparación con la laparotómica. Material y método El estudio consta de 354 pacientes con cuadros de colecistitis aguda intervenidos por vía abierta o laparoscópica desde 2006 a 2009.ResultadosSe han intervenido 253 pacientes por vía laparoscópica, 101 por vía abierta, apreciándose un predominio del sexo masculino (57,67%) y una edad media de 62,83 años. El número de colecistectomía laparoscópica ha pasado del 60% en el 2006, al 79% en 2009. La estancia media (englobando complicadas y no complicadas) hablan a favor del abordaje laparoscópico frente al abierto (mostrando una diferencia de aproximadamente 6 al día). Las complicaciones postoperatorias a lo largo de estos cuatro años en la vía laparoscópica han experimentado un descenso, pasando de un 21,42 a un 11,3%. Las complicaciones locales y globales se correlacionaron significativamente con el tiempo transcurrido entre el inicio de los síntomas agudos y la cirugía, así como con el estado anatomopatológico de la vesícula biliar. Conclusiones El abordaje laparoscópico va adquiriendo un papel cada vez más primordial en el tratamiento de esta dolencia, convirtiéndose en nuestro hospital en la principal opción quirúrgica (AU)

Objective The application of the laparoscopic technique in acute cholecystitis is still subject to controversy. The aim of this study is to asses the applicability, safety, benefits and complications of the laparoscopic approach in patients with acute cholecystitis, as well as the development of this technique in the emergency surgery department of a tertiary hospital, compared to laparotomy. Material and method The study consisted of 354 patients with acute cholecystitis syndromes operated either by open or laparoscopic surgery, during the years 2006 to 2009.ResultsThe laparoscopic method was used in 253 patients, and 101 by the open route, with the slight majority being male (57.67%) and with a mean age of 62.83 years. The number of laparoscopic cholecystectomies increased from 60% in 2006, to 79% in 2009. The mean hospital stay (including those with and without complications) was shorter using the laparoscopic approach, compared to open surgery (showing a difference of approximately 6 days). The postoperative complications in laparoscopy during the four years studied decreased from 21.42 to 11.3%. The local and general complications were significantly associated with time since the start of the acute symptoms and the surgery, as well as the histopathological state of the gall bladder. Conclusions The laparoscopic approach continues to play an increasing role in the treatment of this disease, becoming the main surgical option in our hospital (AU)