The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate. To reduce the incidence of PH by implanting a lightweight mesh in the sublay position. Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery. : The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08). Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.
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)
Transanal total mesorectal excision (TaTME) is a minimally invasive surgical technique that tries to avoid conversion to open surgery. However, specific intraoperative complications and local recurrences have cast some doubt on the suitability of the technique. The primary endpoint of the present study was a composite outcome of conversion surgery. Secondary objectives were to assess postoperative recovery, and pathological and oncological outcomes. This was a prospective, multicentre, randomized, controlled open-label study of patients diagnosed with mid and low rectal adenocarcinoma who underwent laparoscopic TaTME or laparoscopic total mesorectal excision (LaTME). The TaTME technique comprised intracorporeal resection and anastomosis. Main outcomes were conversion to open surgery. Secondary outcomes were postoperative morbidity, mortality, pathological, oncological results, and survival. Modified intention-to-treat (mITT) and per-protocol analyses were performed. The study was conducted between April 2015 and May 2021. Patients were randomized to the LaTME (57 patients) or TaTME (59) group. Fifty patients from the LaTME group and 55 from the TaTME group were eligible for mITT analysis. The procedure was converted to open surgery in 11 patients (11 per cent): 10 (20 per cent) in the LaTME group and 1 (2 per cent) in the laparoscopic TaTME group (difference 18.8, 95 per cent c.i. 30 to 7; P = 0.003). No significant differences were found in terms of postoperative recovery and morbidity at 30 days; nor were there significant differences in anastomotic leakage, although it was less common in laparoscopic TaTME. With a median follow-up of 39 months, there were three instances of local recurrence (6.1 per cent) in the LaTME group and one (1.8 per cent) in the laparoscopic TaTME group (95 per cent c.i. 60 to 69; P = 0.3). Registration number: NCT02550769 (http://www.clinicaltrials.gov). The conversion rate was significantly lower in laparoscopic TaTME than in LaTME. At centres with experienced surgeons, laparoscopic TaTME can avoid conversion to open surgery.
1 January 2014 in World Journal of Gastroenterology
Total mesorectal excision (TME) is the standard treatment for rectal cancer, but complications are frequent and rates of morbidity, mortality and genitourinary alterations are high. Transanal endoscopic microsurgery (TEM) allows preservation of the anal sphincters and, via its vision system through a rectoscope, allows access to rectal tumors located as far as 20 cm from the anal verge. The capacity of local surgery to cure rectal cancer depends on the risk of lymph node invasion. This means that correct preoperative staging of the rectal tumor is necessary. Currently, local surgery is indicated for rectal adenomas and adenocarcinomas invading the submucosa, but not beyond (T1). Here we describe the standard technique for TEM, the different types of equipment used, and the technical limitations of this approach. TEM to remove rectal adenoma should be performed in the same way as if the lesion were an adenocarcinoma, due to the high percentage of infiltrating adenocarcinomas in these lesions. In spite of the generally good results with T1, some authors have published surprisingly high recurrence rates; this is due to the existence of two types of lesions, tumors with good and poor prognosis, divided according to histological and surgical factors. The standard treatment for rectal adenocarcinoma T2N0M0 is TME without adjuvant therapy. In this type of adenocarcinoma, local surgery obtains the best results when complete pathological response has been achieved with previous chemoradiotherapy. The results with chemoradiotherapy and TEM are encouraging, but the scientific evidence remains limited at present.