Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial.

OBJECTIVE: Mild AD can be treated safely and effectively on an outpatient basis without antibiotics. SUMMARY OF BACKGROUND DATA: In recent years, it has shown no benefit of antibiotics in the treatment of uncomplicated AD in hospitalized patients. Also, outpatient treatment of uncomplicated AD has been shown to be safe and effective. METHODS: A Prospective, multicentre, open-label, noninferiority, randomized controlled trial, in 15 hospitals of patients consulting the emergency department with symptoms compatible with AD.The Participants were patients with mild AD diagnosed by Computed Tomography meeting the inclusion criteria were randomly assigned to control arm (ATB-Group): classical treatment (875/125 mg/8 h amoxicillin/clavulanic acid apart from anti-inflammatory and symptomatic treatment) or experimental arm (Non-ATB-Group): experimental treatment (antiinflammatory and symptomatic treatment). Clinical controls were performed at 2, 7, 30, and 90 days.The primary endpoint was hospital admission. Secondary endpoints included number of emergency department revisits, pain control and emergency surgery in the different arms. RESULTS: Four hundred and eighty patients meeting the inclusion criteria were randomly assigned to Non-ATB-Group (n = 242) or ATB-Group (n = 238). Hospitalization rates were: ATB-Group 14/238 (5.8%) and Non-ATB-Group 8/242 (3.3%) [mean difference 2.58%, 95% confidence interval (CI) 6.32 to -1.17], confirming noninferiority margin. Revisits: ATB-Group 16/238 (6.7%) and Non-ATB-Group 17/242 (7%) (mean difference -0.3, 95% CI 4.22 to -4.83). Poor pain control at 2 days follow up: ATB-Group 13/230 (5.7%), Non-ATB-Group 5/221 (2.3%) (mean difference 3.39, 95% CI 6.96 to -0.18). CONCLUSIONS: Nonantibiotic outpatient treatment of mild AD is safe and effective and is not inferior to current standard treatment. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02785549); EU Clinical Trials Register (2016-001596-75).

Prospective Randomized Study on Stapled Anopexy Height and Its Influence on Recurrence for Hemorrhoidal Disease Treatment.

OBJECTIVES: To know the influence of the stapled line height (SLH) in the recurrence rate and the postoperative disturbances in stapled anopexy (SA) for the treatment of hemorrhoids. DESIGN: Simple randomized double-blind controlled clinical trial. Randomization with closed-envelope technique in two groups with two different SLH. SETTING: Colorectal Surgery Unit. Department of General Surgery. Hospital de Mataró (Barcelona, Spain). PARTICIPANTS: 119 patients with the diagnosis of symptomatic third- and fourth-grade hemorrhoids were included. INTERVENTION: SA was performed with two different SLH: group A, 4.5 cm (58 patients) and group B, 6 cm (61 patients) from the external anal verge. Postoperative disturbances were evaluated by a colorectal surgeon who was blind for the randomization and pain was measured (visual analogic scale) one week and 3 months after surgery. Mean operative time, number of hemostatic stitches performed and resected mucosal area were considered as well. Mean follow-up was 11.05 ± 1.6 years. RESULTS: Differences between the operative time and resected mucosa-submucosa area were not found. The patients of group A needed a significantly higher number of stitches for intraoperative bleeding control along the stapled line. We did not found differences between both groups in terms of postoperative pain neither anorectal disturbances. At the follow-up, persistence of symptomatology was 10.41% in group A and 10.71% in group B, without statistically significance. Neither mortality nor undesirable effects occurred in the series. CONCLUSIONS: SLH do not influence the recurrence rate neither the postoperative evolution in SA. TRIAL REGISTRATION: Clinical Trials NCT03383926.

Anopexia mucosa grapada: experiencia y consideraciones sobre la técnica / Circular mucosal anopexy: Experience and technical considerations

INTRODUCCIÓN: La anopexia mucosa circular (AMC) condiciona un postoperatorio menos molesto que las técnicas resectivas, pero no está exenta de complicaciones y presenta una mayor recidiva. El objetivo del presente estudio es evaluar la eficacia de la AMC en el tratamiento de las hemorroides y del prolapso mucoso rectal (PMR). MÉTODOS: Entre 1999 y 2011 fueron intervenidos en nuestro hospital 613 pacientes por hemorroides o PMR: en 327 casos se realizó AMC (PMR en 28 casos, grado II en 46, grado III en 146 y grado IV en 107 casos). La AMC se realizó en régimen de cirugía mayor ambulatoria (CMA) en el 79% de los casos. Consideramos la recidiva y comparamos los grupos de no recidiva y recidiva. Evaluamos el dolor medido por Escala Visual Analógica (EVA) y las complicaciones postoperatorias. RESULTADOS: En 31 pacientes se registró recidiva de la sintomatología que precisó algún tipo de intervención: PMR en 5 pacientes, grado II en 2, grado III en 17 y grado IV en 7. No existieron diferencias significativas entre los pacientes con reccidiva y los pacientes sin recidiva en cuanto a género, tiempo operatorio ni grado hemorroidal, pero sí respecto a la edad. El 81,3% de los pacientes expresó dolor ≤ 2 en EVA a la semana. Cinco pacientes se reintervinieron por sangrado postoperatorio inmediato. Seis pacientes precisaron ingreso por dolor postoperatorio. CONCLUSIONES: La recidiva en la AMC es superior a la de las técnicas resectivas. La AMC es una técnica útil para el tratamiento de la enfermedad hemorroidal en régimen de CMA. El grado de dolor y las complicaciones son bajos

INTRODUCTION: Circular mucosal anopexy (CMA) achieves a more comfortable postoperative period than resective techniques. But complications and recurrences are not infrequent. This study aims to evaluate of the efficacy of CMA in the treatment of hemorrhoids and rectal mucosal prolapse (RMP). METHOD: From 1999 to 2011, 613 patients underwent surgery for either hemorrhoids or RMP in our hospital. CMA was performed in 327 patients. Gender distribution was 196 male and 131 female. Hemorrhoidal grades were distributed as follows: 28 patients had RMP, 46 2nd grade, 146 3rd grade and 107 4th grade. Major ambulatory surgery (MAS) was performed in 79.9%. Recurrence of hemorrhoids was studied and groups of recurrence and no-recurrence were compared. Postoperative pain was evaluated by Visual Analogical Scale (VAS) as well as early complications. RESULTS: A total of 31 patients needed reoperation (5 RMP, 2 with 2nd grade, 17 with 3rd grade,/with 4th grade). No statistically significant differences were found between the non-recurrent group and the recurrent group with regards to gender, surgical time or hemorrhoidal grade, but there were differences related to age. In the VAS, 81.3% of patients expressed a postoperative pain ≤ 2 at the first week. Five patients needed reoperation for early postoperative bleeding. Six patients needed admission for postoperative pain. CONCLUSIONS: Recurrence rate is higher in CMA than in resective techniques. CMA is a useful technique for the treatment of hemorrhoids in MAS. Pain and the rate of complications are both low

Circular mucosal anopexy: Experience and technical considerations. / Anopexia mucosa grapada: experiencia y consideraciones sobre la técnica.

INTRODUCTION: Circular mucosal anopexy (CMA) achieves a more comfortable postoperative period than resective techniques. But complications and recurrences are not infrequent. This study aims to evaluate of the efficacy of CMA in the treatment of hemorrhoids and rectal mucosal prolapse (RMP). METHOD: From 1999 to 2011, 613 patients underwent surgery for either hemorrhoids or RMP in our hospital. CMA was performed in 327 patients. Gender distribution was 196 male and 131 female. Hemorrhoidal grades were distributed as follows: 28 patients had RMP, 46 2nd grade, 146 3rd grade and 107 4th grade. Major ambulatory surgery (MAS) was performed in 79.9%. Recurrence of hemorrhoids was studied and groups of recurrence and no-recurrence were compared. Postoperative pain was evaluated by Visual Analogical Scale (VAS) as well as early complications. RESULTS: A total of 31 patients needed reoperation (5 RMP, 2 with 2nd grade, 17 with 3rd grade,/with 4th grade). No statistically significant differences were found between the non-recurrent group and the recurrent group with regards to gender, surgical time or hemorrhoidal grade, but there were differences related to age. In the VAS, 81.3% of patients expressed a postoperative pain ≤ 2 at the first week. Five patients needed reoperation for early postoperative bleeding. Six patients needed admission for postoperative pain. CONCLUSIONS: Recurrence rate is higher in CMA than in resective techniques. CMA is a useful technique for the treatment of hemorrhoids in MAS. Pain and the rate of complications are both low.