DaBlaCa-16: Retrosigmoid Versus Conventional Ileal Conduit in Robot-assisted Radical Cystectomy, the MOSAIC Randomized Controlled Trial-Feasibility and 90-day Postoperative Complications.

Background: Approximately 15% of patients undergoing radical cystectomy (RC) develop benign ureteroenteric strictures. Of these strictures, the majority are located in the left ureter. To lower the rate of strictures, a retrosigmoid ileal conduit has been suggested. Objective: To investigate the feasibility and safety of a retrosigmoid ileal conduit during robot-assisted RC in bladder cancer patients. Design setting and participants: This randomized controlled trial included 303 patients from all five cystectomy centers in Denmark from May 2020 to August 2022. Participants were diagnosed with bladder cancer and scheduled for robot-assisted RC with an ileal conduit. Intervention: Intervention group: a retrosigmoid ileal conduit was constructed using approximately 25 cm of the terminal ileum and tunneled behind the sigmoid where the left ureter was anastomosed from end to side. Control group: the conventional ileal conduit ad modum Bricker with individual end-to-side anastomoses. Outcome measurements and statistical analysis: Patients were analyzed by the intention-to-treat approach. Complications within 90 d were categorized using the Clavien-Dindo grading system and compared using Fisher's exact test. Wilcoxon's test was used for pre- and postoperative renal function. Results and limitations: Of the 149 patients randomized for the retrosigmoid ileal conduit (MOSAIC), a total of 137 (92%) patients received the allocated conduit. Postoperative complications were distributed equally between the two groups. The relative risk of Clavien-Dindo complications of grade ≥III was 1.12 (95% confidence interval: 0.96-1.31) in the intervention group compared with the control group. Conclusions: The retrosigmoid ileal conduit with robot-assisted RC was technically feasible. Early postoperative complications were not significantly different when comparing the two groups. Further investigation of long-term complications, including strictures, is needed. Patient summary: We compared a conventional urinary diversion with a longer conduit to prevent constriction from developing in the ureters. The new conduit is feasible and safe within the first 90 d, with no differences in postoperative complications from those of the conventional diversion.

Robot-assisted radical cystectomy with intracorporeal urinary diversion: a Danish 11-year series.

OBJECTIVES: To evaluate the oncological and perioperative outcomes from a large, single-centre, robot-assisted radical cystectomy (RARC) cohort performed with intracorporeal urinary diversion (ICUD). PATIENTS AND METHODS: Patients who underwent RARC because of bladder cancer or recurrent carcinoma in situ from June 2009 until August 2020 at Herlev and Gentofte Hospital were prospectively and consecutively included. Kaplan-Meier survival analysis was used to estimate recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS). A Cox proportional hazards model was used to identify individual predictors of outcomes. Multiple logistic regression analysis was used to identify predictors of high-grade complications (Clavien-Dindo Grade ≥III). RESULTS: A total of 542 patients were included. The median (interquartile range) follow-up was 5.3 (2.73-8.06) years. In all, 78 patients (14%) were converted to open surgery; 15 (3%) during cystectomy and 63 patients (12%) were converted from ICUD to extracorporeal urinary diversion. The 5-year RFS, CSS and OS rates were 63% (95% confidence interval [CI] 59%-68%), 75% (95% CI 72%-80%) and 67% (95% CI 63%-72%), respectively. Pathological non-organ-confined disease (tumour stage >T2 or positive lymph nodes) predicted poorer RFS, CSS and OS. Reconstruction with a neobladder (20% of cases) compared to an ileal conduit was the only predictor of high-grade complications (odds ratio 2.54, 95% CI 1.46-4.43; P < 0.001). CONCLUSION: A RARC with ICUD is feasible as a standard surgical procedure for bladder cancer with only a few patients converted to open surgery. In our hands reconstruction with a neobladder was a strong predictor for high-grade complications.

Hospitalization for transurethral bladder resection reduces quality of life in Danish patients with non-muscle-invasive bladder tumour.

Objective The aim of the study was to evaluate the impact of transurethral resection of bladder tumour (TURBT) on patients' quality of life (QoL) and to validate a tool to quantify problems associated with TURBT in a Danish population. Materials and methods A prospective study was carried out using a combination of questionnaires and interviews. The study included 165 consecutive patients undergoing a TURBT owing to non-muscle-invasive bladder cancer (NMIBC) from 1 May 2011 to 30 April 2012. Seven patients were selected for interviews. The Danish translation of the QLQ-NMIBC24 Quality of Life Questionnaire for NMIBC, from the European Organisation for Research and Treatment of Cancer (EORTC), was used. The interviews were semi-structured. The reliability of the subscales quantifying QoL as defined by the EORTC was tested by computing Cronbach's coefficient alpha and confirmatory factor analysis. The interviews were analysed using the phenomenological method. Results The questionnaire was returned by 121 (77%) patients at a mean of 12 days after hospital discharge. Over half had substantial voiding problems and one-third had emotional concerns. These results were confirmed by the interviews. The mean ± SD score for urinary symptoms was 45.21 ± 23.9 and the mean score for the future worries subscale was 39.9 ± 29.9. Cronbach's coefficient alpha was 0.84 for the urinary symptom subscale and 0.93 for the future worries subscale, which satisfied the reliability criterion for clinical use. Conclusions This first prospective study on QoL following TURBT in patients with NMIBC shows that TURBT has a significant impact on QoL. The Danish version of the EORTC questionnaire QLQ-NMIBC24 has been validated and confirmed in a Danish population.

First Danish single-institution experience with radical prostatectomy: impact of surgical margins on biochemical outcome.

OBJECTIVE: This study aimed to investigate the impact of positive surgical margins (PSMs), stratified by location and extension, on biochemical outcome after radical retropubic prostatectomy (RRP). MATERIAL AND METHODS: The study included data from 605 consecutive patients treated with RRP for localized prostate cancer. Patients with node-positive disease were excluded. Biochemical recurrence-free survival was calculated using the Kaplan-Meier method. Univariate and multivariate analysis was used to assess risk factors. RESULTS: The overall PSM rate was 35.4%. Eighty-three per cent (82.7%) of these had a single PSM, whereas 17.3% of patients had two or more PSMs. Apical PSMs were present in 42.5% and non-apical in 57.5%. The presence of any PSM had a significant impact on the risk of biochemical recurrence (BR) [hazard ratio (HR) = 3.3, p < 0.0001]. Compared with margin-negative patients, both apical and non-apical PSMs increased the risk of BR (HR = 2.1 and 4.2, p = 0.02 and p < 0.0001, respectively). The number of PSMs also influenced the risk of BR (one PSM: HR = 2.8, p < 0.0001, vs two or more PSMs: HR = 5.5, p < 0.0001). In multivariate analysis, pT category, PSA and prostatectomy Gleason score independently increased the risk of BR. In an exploratory multivariate analysis of pT2 tumours, the impact of apical PSMs on biochemical recurrence-free survival (BRFS) was not statistically significant, although with an HR of 2.1. Non-apical PSM was associated with a significantly increased risk of BR (HR = 3.4, p = 0.01). Number of PSMs did not influence the risk of BR in multivariate analysis. CONCLUSION: The presence of PSMs after RRP is associated with a higher risk of BR. Multiple and non-apical PSMs are associated with a significantly higher risk of BR compared to single and apical PSMs.

[Effects of traffic-generated ultrafine particles on health]. / Helbredseffekter af trafikgenererede ultrafine partikler.

Epidemiological studies have consistently shown relation between exposure to particulate matter in urban air and cardiovascular and pulmonary morbidity and mortality. Some recent population studies suggest that the ultrafine fraction of particulate matter generated by motorised vehicles is particularly damaging. Animal studies and cell culture experiments support this hypothesis and address the possible mechanisms of action. Inhalation of particulate matter, especially ultrafine particles, causes oxidative stress and inflammation in lung tissue, which affects the lung cells per se, as well as the cardiovascular system.

[Effects on health of particulate air pollution in Denmark--a quantitative assessment]. / Helbredseffekter af partikulaer luftforurening i Danmark--et forsøg på kvantificering.

INTRODUCTION: Ambient air pollution is a risk factor for mortality and morbidity. The aim of this study was to quantify the health effects related to particulate matter (PM10) in Denmark. MATERIALS AND METHODS: We used relative risk estimates in relation to PM10 based on the epidemiological literature. Population exposure to PM10 was calculated. Cases attributable to PM10 were estimated for mortality, cardiovascular and respiratory hospital admissions, chronic bronchitis, acute bronchitis, restricted activity days, and asthma attacks. Moreover, we attempted to estimate health-related gains from equipping all heavy-duty vehicles in Denmark with particle filters. RESULTS: We estimated the average population PM10 exposure to be about 22 micrograms/m3, about one third of which can be attributed to natural (not man-made) PM10. The number of cases per year attributable to the estimated exposure included about 5,000 deaths, about 5,000 hospital admissions, about 5,000 cases of chronic bronchitis, about 17,000 cases of acute bronchitis, about 200,000 asthma attacks, and about three million restricted activity days. The health-related gains from installing particle filters on all heavy-duty vehicles in Denmark are uncertain; the estimates for mortality ranged from 22 to 1,250, depending on the assumptions. DISCUSSION: Although air pollution constitutes only a minor risk factor on the individual level, it seems to be a major public health problem. The particle characteristics responsible for the estimated health effects are not well understood. The ultrafine particle fraction may cause a much greater impact on health than indicated by the mass.