Office-based approach to urinary tract infections in 50 000 patients: results from the REWIND study

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Rates and Predictors of Perioperative Complications in Cytoreductive Nephrectomy: Analysis of the Registry for Metastatic Renal Cell Carcinoma

Background: Cytoreductive nephrectomy (CN) plays an important role in the treatment of a subgroup of metastatic renal cell carcinoma (mRCC) patients. Objective: We aimed to evaluate morbidity associated with this procedure and identify potential predictors thereof to aid patient selection for this procedure and potentially improve patient outcomes. Design, setting, and participants: Data from 736 mRCC patients undergoing CN at 14 institutions were retrospectively recorded in the Registry for Metastatic RCC (REMARCC). Outcome measurements and statistical analysis: Logistic regression analysis was used to identify predictors for intraoperative, any-grade (AGCs), low-grade, and high-grade (HGCs) postoperative complications (according to the Clavien-Dindo classification) as well as 30-d readmission rates. Results and limitations: Intraoperative complications were observed in 69 patients (10.9%). Thrombectomy (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.08-1.75, p = 0.009) and adjacent organ removal (OR 2.7, 95% CI 1.38-5.30) were significant predictors of intraoperative complications at multivariable analysis. Two hundred seventeen patients (29.5%) encountered AGCs, while 45 (6.1%) encountered an HGC, of whom 10 (1.4%) died. Twenty-four (3.3%) patients had multiple postoperative complications. Estimated blood loss (EBL; OR 1.49, 95% CI 1.08-2.05, p = 0.01) was a significant predictor of AGCs at multivariable analysis. CN case load (OR 0.13, 95% CI 0.03-0.59, p = 0.009) and EBL (OR 2.93, 95% CI 1.20-7.15, p = 0.02) were significant predictors solely for HGCs at multivariable analysis. Forty-one patients (11.5%) were readmitted within 30 d of surgery. No significant predictors were identified. Results were confirmed in a subanalysis focusing solely on patients treated in the contemporary targeted therapy era. Conclusions: Morbidity associated with CN is not negligible. Predictors of high-grade postoperative morbidity are predominantly indicators of complex surgery. EBL is a strong predictor of postoperative complications. CN case load correlates with lower high-grade morbidity and highlights the benefit of centralization of complex surgery. However, risks and benefits should be balanced when considering CN in mRCC patients. Patient summary: We studied patients with metastatic renal cancer to evaluate the outcomes associated with the surgical removal of the primary kidney tumor. We found that this procedure is often complex and adverse events are not uncommon. High intraoperative blood loss and a small number of cases performed at the treating center are associated with a higher rate of postoperative complications

Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

<p>Abstract</p> <p>Background</p> <p>In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.</p> <p>Method</p> <p>The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at <url>http://www.seleblat.org.</url> Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.</p> <p>Design</p> <p>The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.</p> <p>Discussion</p> <p>This is the first report on a selenium randomized trial in bladder cancer patients.</p> <p>Trial registration</p> <p>ClinicalTrials.gov identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00729287">NCT00729287</a></p

Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Background Metastatic castration-resistant prostate cancers are enriched for DNA repair gene defects (DRDs) that can be susceptible to synthetic lethality through inhibition of PARP proteins. We evaluated the anti-tumour activity and safety of the PARP inhibitor niraparib in patients with metastatic castration-resistant prostate cancers and DRDs who progressed on previous treatment with an androgen signalling inhibitor and a taxane. Methods In this multicentre, open-label, single-arm, phase 2 study, patients aged at least 18 years with histologically confirmed metastatic castration-resistant prostate cancer (mixed histology accepted, with the exception of the small cell pure phenotype) and DRDs (assessed in blood, tumour tissue, or saliva), with progression on a previous next-generation androgen signalling inhibitor and a taxane per Response Evaluation Criteria in Solid Tumors 1.1 or Prostate Cancer Working Group 3 criteria and an Eastern Cooperative Oncology Group performance status of 0–2, were eligible. Enrolled patients received niraparib 300 mg orally once daily until treatment discontinuation, death, or study termination. For the final study analysis, all patients who received at least one dose of study drug were included in the safety analysis population; patients with germline pathogenic or somatic biallelic pathogenic alterations in BRCA1 or BRCA2 (BRCA cohort) or biallelic alterations in other prespecified DRDs (non-BRCA cohort) were included in the efficacy analysis population. The primary endpoint was objective response rate in patients with BRCA alterations and measurable disease (measurable BRCA cohort). This study is registered with ClinicalTrials.gov, NCT02854436. Findings Between Sept 28, 2016, and June 26, 2020, 289 patients were enrolled, of whom 182 (63%) had received three or more systemic therapies for prostate cancer. 223 (77%) of 289 patients were included in the overall efficacy analysis population, which included BRCA (n=142) and non-BRCA (n=81) cohorts. At final analysis, with a median follow-up of 10·0 months (IQR 6·6–13·3), the objective response rate in the measurable BRCA cohort (n=76) was 34·2% (95% CI 23·7–46·0). In the safety analysis population, the most common treatment-emergent adverse events of any grade were nausea (169 [58%] of 289), anaemia (156 [54%]), and vomiting (111 [38%]); the most common grade 3 or worse events were haematological (anaemia in 95 [33%] of 289; thrombocytopenia in 47 [16%]; and neutropenia in 28 [10%]). Of 134 (46%) of 289 patients with at least one serious treatment-emergent adverse event, the most common were also haematological (thrombocytopenia in 17 [6%] and anaemia in 13 [4%]). Two adverse events with fatal outcome (one patient with urosepsis in the BRCA cohort and one patient with sepsis in the non-BRCA cohort) were deemed possibly related to niraparib treatment. Interpretation Niraparib is tolerable and shows anti-tumour activity in heavily pretreated patients with metastatic castration-resistant prostate cancer and DRDs, particularly in those with BRCA alterations

Maintenance training for laparoscopic suturing: the quest for the perfect timing and training model: a randomized trial

Although excellent training programs exist for acquiring the challenging skill required in laparoscopic suturing, without subsequent reinforcement, performance is prone to decay. Therefore, maintenance training is proposed to ensure better skill retention. This study aimed to elucidate the ideal timing and frequency of maintenance training as well as the best model to be used for this training. After completing a proficiency-based laparoscopic suturing training, 39 medical students attended different maintenance programs represented by four groups: a control group without additional training (group 1), a massed training group with one supervised training session (150 min) after 2.5 months (group 2), and two distributed training groups with five monthly unsupervised training sessions of 30 min on a box trainer (group 3) or the LapMentor(®) (group 4). Retention testing, after 5 months, included suturing on a box trainer and on a cadaver porcine Nissen model. Performance scores (time and errors) were expressed in seconds. Afterward, time needed to regain proficiency was measured. On the box trainer, the median performance scores were 233 s (interquartile range [IQR] 27 s) for group 1, 180 s (IQR 55 s) for group 2, 169 s (IQR 26 s) for group 3, and 226 s (IQR 66 s) for group 4 (p = 0.03). No difference was seen between groups 2 and 3, both of which significantly outperformed groups 1 and 4. On the porcine Nissen model, no differences were detected between the groups (p = 0.53). Group 3 reached proficiency more quickly than the other groups. Maintenance training is a valuable and necessary addendum to proficiency-based training programs for laparoscopic suturing. A maintenance-training interval of 1 month with unsupervised training sessions on simple box trainers seems ideal. The LapMentor(®) did not show any benefit. Performance differences between groups did not translate to a clinically relevant model, indicating that transfer of training is not perfec

Effect of a short preclinical laparoscopy course for interns in surgery: a randomized controlled trial

Surgical interns are often not well prepared and have high anxiety about the execution of basic technical skills. This study investigates whether a short preclinical course focusing on laparoscopic camera-navigating skills is useful in the preparation for internship. Through randomization, an experimental group who attended a short laparoscopic training session and a control group were created. Students' interest for this training and their confidence for laparoscopic exposure during surgical internship were inquired. During internship, camera-navigating skills were assessed by the operating surgeons (using a validated global rating scale) as well as by the students themselves (using a 10-points Likert scale). All research was performed in the Center for Surgical Technologies, Leuven, Belgium. A total of 205 fifth-year medical students at the University of Leuven, Belgium. Of the control group students, 80% were interested in attending the training session. There was no difference in confidence between experimental and control group. According to the surgeons and students, there was a significant improvement in clinical performance from the first (scores on global rating and Likert scales ±50%) to the last procedure (scores ±70%) for both groups. However, there was no difference in performance between groups. Students are very interested in attending a preclinical laparoscopic training session. However, trained students did not display higher confidence or better clinical performance during internship. Even without previous training, students are fast to acquire the necessary skills during surgical internshi

Porcine cadaver organ or virtual-reality simulation training for laparoscopic cholecystectomy: a randomized, controlled trial

As conventional laparoscopic procedural training requires live animals or cadaver organs, virtual simulation seems an attractive alternative. Therefore, we compared the transfer of training for the laparoscopic cholecystectomy from porcine cadaver organs vs virtual simulation to surgery in a live animal model in a prospective randomized trial. After completing an intensive training in basic laparoscopic skills, 3 groups of 10 participants proceeded with no additional training (control group), 5 hours of cholecystectomy training on cadaver organs (= organ training) or proficiency-based cholecystectomy training on the LapMentor (= virtual-reality training). Participants were evaluated on time and quality during a laparoscopic cholecystectomy on a live anaesthetized pig at baseline, 1 week (= post) and 4 months (= retention) after training. All research was performed in the Center for Surgical Technologies, Leuven, Belgium. In total, 30 volunteering medical students without prior experience in laparoscopy or minimally invasive surgery from the University of Leuven (Belgium). The organ training group performed the procedure significantly faster than the virtual trainer and borderline significantly faster than control group at posttesting. Only 1 of 3 expert raters suggested significantly better quality of performance of the organ training group compared with both the other groups at posttesting (p < 0.01). There were no significant differences between groups at retention testing. The virtual trainer group did not outperform the control group at any time. For trainees who are proficient in basic laparoscopic skills, the long-term advantage of additional procedural training, especially on a virtual but also on the conventional organ training model, remains to be prove