Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain).

BACKGROUND: Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma. METHODS: This is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6-12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema. DISCUSSION: Several studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.

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.

Importance of Resection Margins in the Treatment of Rectal Adenomas by Transanal Endoscopic Surgery.

BACKGROUND: Polypectomy is the gold standard for treating colorectal adenomas up to 2 cm in size. For larger lesions, various procedures ranging from endoscopy to transanal surgery can be performed and achieve varying results for en bloc resection and recurrence. There are no clear guidelines for dealing with involved resection margins. We assess the recurrence of rectal adenomas operated using TEM with full-thickness wall excision with or without free resection margins and define optimal endoscopic follow-up. METHOD: Observational study with prospective data collection, including patients undergoing TEM between 6/2004 and 11/2017, with definitive diagnosis of rectal adenoma. Data on epidemiological, preoperative, surgical, postoperative, pathological, and follow-up variables were recorded. Univariate analysis, follow-up risk function, and multivariate logistic regression analysis were performed to detect risk factors for recurrence. RESULTS: TEM was indicated in 736 patients; 481 adenomas were identified in the preoperative biopsy, of which 95 were infiltrating adenocarcinomas (19.8%) in the definitive pathology study. With a minimum follow-up of 1 year, 372 patients were included. Pathology study showed free margins in 324 (87%). Recurrences were recorded in 15 patients (4%), up to 18 months in the free margins group and up to 24 months in the involved margins group. Thirteen patients with recurrence (86.6%) were treated with TEM. No predictors of recurrence were found in the multivariate analysis. CONCLUSION: TEM is the technique of choice for treating rectal adenomas and recurrences, achieving a low relapse rate. Follow-up must be adapted to resection margins and should be extended to 24 months.

Multicentre, controlled, randomized clinical trial to compare the efficacy and safety of ambulatory treatment of mild acute diverticulitis without antibiotics with the standard treatment with antibiotics.

PURPOSE: Acute diverticulitis (AD) is a highly prevalent disease in Spain. Its chronic-recurrent appearance and high rate of relapse mean that it has a major epidemiological and economic impact on our health system. In spite of this, it has not been studied in any great depth. Reassessing its etiopathology, recent studies have observed that it is an inflammatory disease-not, as classic theories had postulated, an infectious one. In the light of these findings, the suitability of antibiotics for its treatment has been reconsidered. At present, however, the evidence for incorporating these findings into clinical practice guidelines remains insufficient. METHODS: This study was designed to analyse the safety and efficacy of a non-antibiotic treatment for mild AD. Patients with mild AD (grade 0 in the modified Neff classification) who meet the inclusion criteria will be randomly assigned to one of two outpatient treatment strategies: (a) classical treatment (antibiotics, anti-inflammatories and low-fibre diet) or (b) experimental treatment (anti-inflammatories and low-fibre diet). Clinical controls will be performed at 2, 7, 30, and 90 days. We will determine whether there are any differences in the clinical outcome between groups. The main objective is to demonstrate that antibiotics neither accelerate the resolution of the disease nor decrease the number of complications and/or recurrences in these patients, suggesting that their use may be unnecessary. CONCLUSIONS: The results of this trial will help to optimize and homogenize the treatment of this highly prevalent disease. However, more studies are required before firm changes can be introduced in international clinical practice guidelines. TRIAL REGISTRATION: The trial has been registered at the ClinicalTrials.gov database (ID: NCT02785549) and the EU Clinical Trials Register database (EudraCT number: 2016-001596-75).

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.

Caval agenesis in the pediatric liver donor.

The following is the first report of a pediatric organ donor with caval agenesis and the subsequent use of this liver for transplantation. Caval embryology and potential implications of utilizing a donor liver with caval agenesis are reviewed.