Insurance Firms in Process of Industrialization

Background: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo) radiotherapy compared to primary perineal wound closure. Methods/Design: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo) radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia

A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial)

Background. Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. Methods. A randomized multicenter pragmatic clinical trial comparin

Microbiota composition and mucosal immunity in patients with asymptomatic diverticulosis and controls

Introduction The etiology of diverticulosis is still poorly understood. However, in patients with diverticulitis, markers of mucosal inflammation and microbiota alterations have been found. The aim of this study was to evaluate potential differences of the gut microbiota composition and mucosal immunity between patients with asymptomatic diverticulosis and controls. Methods We performed a prospective study on patients who underwent routine colonoscopy for causes not related to diverticular disease or inflammatory bowel disease. Participants were grouped based on the presence or absence of diverticula. Mucosal biopsies were obtained from the sigmoid and transverse colon. Microbiota composition was analyzed with IS-pro, a 16S-23S based bacterial profiling technique. To predict if patients belonged to the asymptomatic diverticulosis or control group a partial least squares discriminant analysis (PLS-DA) regression model was used. Inflammation was assessed by neutrophil and lymphocyte counts within the taken biopsies. Results Forty-three patients were enrolled. Intestinal microbiota profiles were highly similar within individuals for all phyla. Between individuals, microbiota profiles differed substantially but regardless of the presence (n = 19) of absence (n = 24) of diverticula. Microbiota diversity in both sigmoid and transverse colon was similar in all participants. We were not able to differentiate between diverticulosis patients and controls with a PLS-DA model. Mucosal lymphocyte counts were comparable among both groups; no neutrophils were detected in any of the studied biopsies. Conclusions Microbiota composition and inflammatory markers were comparable among asymptomatic diverticulosis patients and controls. This suggests that the gut microbiota and mucosal inflammation do not play a major role in the pathogenesis of diverticula formation

The efficacy of continuous-flow cryo and cyclic compression therapy after hip fracture surgery on postoperative pain: design of a prospective, open-label, parallel, multicenter, randomized controlled, clinical trial

10.1186/s12891-016-1000-4BMC MUSCULOSKELETAL DISORDERS17

Quality of Life and Persistent Symptoms After Uncomplicated Acute Diverticulitis

BACKGROUND: Although acute diverticulitis and its recurrence are well studied, little is known about the period after these attacks have passed. Many patients appear to be affected by persistent symptoms that impair quality of life. The few published studies on this topic are mostly limited by the lack of CT confirmation of the acute diverticulitis diagnosis, low numbers of patients, or cross-sectional design. OBJECTIVE: This study longitudinally evaluated quality of life and symptoms after antibiotic or observational treatment of uncomplicated acute diverticulitis. DESIGN: This was an observational study of randomized clinical trial data. SETTINGS: This study was conducted at a single tertiary care center. PATIENTS: Patients with CT-proven, primary, left-sided, uncomplicated acute diverticulitis were randomly assigned to observational or antibiotic treatment. MAIN OUTCOME MEASURES: Quality of life was assessed using questionnaires (EuroQol 5D, Short Form-36, and Gastrointestinal Quality of Life Index) at baseline and 3, 6, 12, and 24 months after random assignment. Patients were considered to have persistent symptoms when specific quality-of-life scores at the 12- and 24-month follow-ups were among the lowest 16% of scores measured in a healthy reference group. RESULTS: A total of 528 patients were included. No difference was detected between the observational and antibiotic groups in any quality-of-life score during follow-up. Overall, 32.2% to 38.2% of patients had persistent symptoms after 1 or 2 years, depending on which questionnaire (sub)score was assessed. Risk factors for persistent symptoms based on to the Gastrointestinal Quality of Life index GI symptoms score included a mean pain score ≥3.75 (OR = 2.77 (95% CI, 1.60-4.80)) during the first 10 days of disease and prolonged (≥28 d) time to recovery (OR = 2.25 (95% CI, 1.31-3.88)). Flatulence, rumblings, bloating, fullness, and many stools were the top 5 complaints at the 12- and 24-month follow-ups. LIMITATIONS: The study was limited by possible selection bias of patients included in a randomized controlled trial. CONCLUSIONS: More than one third of patients experience persistent symptoms after an episode of acute uncomplicated diverticulitis. Long-term quality of life is comparable after initial antibiotic or observational treatment. See Video Abstract at http://links.lww.com/DCR/A916