15-year biochemical failure, metastasis, salvage therapy, and cancer-specific and overall survival rates in men treated with robotic radical prostatectomy for PSA-screen detected prostate cancer.

BACKGROUND: An informed decision regarding a treatment option requires data on its long-term efficacy and side-effect profile. While the side-effects of robotic radical prostatectomy have been well-quantified, the data on its long-term efficacy are lacking. We here provide 15-year oncological outcomes of clinically-localized prostate cancer (CLPCa) patients treated with robot-assisted laparoscopic prostatectomy (RALP). METHODS: We treated 1,807 men with CLPCa with RALP between 2001 and 2005 and prospectively collected follow-up data through 2020. We examined the rates of biochemical failure (BCF), metastatic progression, secondary therapy use, PCa-specific mortality (PCSM), and overall survival (OS) using Kaplan-Meier and competing-risk cumulative incidence methods as appropriate. RESULTS: The median follow-up was 14.1 years. Six hundred eight and 312 men had D'Amico intermediate- and high-risk disease, respectively. Overall, the 15-year rates of BCF, metastasis, secondary therapy use, PCSM, and OS were 28.1%, 4.0%, 16.3%, 2.5%, and 82.1%, respectively. The rates of oncologic failure increased with increasing D'Amico (preoperative) and Diaz (postoperative) risk scores - BCF, metastasis, and PCSM rates in D'Amico low-, intermediate-, and high-risk groups at 15-years were 15.2%, 38.3%, and 44.1% [BCF], 1.1%, 4.1%, and 13.0% [metastasis], and 0.5%, 3.4%, and 6.6% [PCSM], respectively, and in Diaz risk groups 1, 2, 3, 4, and 5 were 5.5%, 20.6%, 41.8%, 66.9%, and 89.2% [BCF], 0%, 0.5%, 3.2%, 20.5%, and 60.0% [metastasis], and 0%, 0.8%, 0.6%, 13.5%, and 37.5% [PCSM], respectively. The OS rates in D'Amico low-to-high and Diaz 1-to-5 risk groups at 15-years were 85.9%, 78.6%, and 75.2%, and 89.4%, 83.2%, 80.6%, 67.2%, and 23.4%, respectively. CONCLUSIONS: Men diagnosed with clinically-localized prostate cancer in the contemporaneous PSA-screening era and treated with RALP achieve durable long-term oncological control. The data reported here (in a risk-stratified manner) represent the longest follow-up after robotic radical prostatectomy, and as such, should be of value when counseling patients regarding expected oncologic outcomes from RALP.

The impact of a wireless audio system on communication in robotic-assisted laparoscopic surgery: A prospective controlled trial.

BACKGROUND: Robotic surgery presents a challenge to effective teamwork and communication in the operating theatre (OR). Our objective was to evaluate the effect of using a wireless audio headset device on communication, efficiency and patient outcome in robotic surgery. METHODS AND FINDINGS: A prospective controlled trial of team members participating in gynecologic and urologic robotic procedures between January and March 2015. In the first phase, all surgeries were performed without headsets (control), followed by the intervention phase where all team members used the wireless headsets. Noise levels were measured during both phases. After each case, all team members evaluated the quality of communication, performance, teamwork and mental load using a validated 14-point questionnaire graded on a 1-10 scale. Higher overall scores indicated better communication and efficiency. Clinical and surgical data of all patients in the study were retrieved, analyzed and correlated with the survey results. The study included 137 procedures, yielding 843 questionnaires with an overall response rate of 89% (843/943). Self-reported communication quality was better in cases where headsets were used (113.0 ± 1.6 vs. 101.4 ± 1.6; p < .001). Use of headsets reduced the percentage of time with a noise level above 70 dB at the console (8.2% ± 0.6 vs. 5.3% ± 0.6, p < .001), but had no significant effect on length of surgery nor postoperative complications. CONCLUSIONS: The use of wireless headset devices improved quality of communication between team members and reduced the peak noise level in the robotic OR.

Hospital admissions for tuberculous pericarditis in the United States 2002-2014.

Background: Extra pulmonary manifestations of tuberculosis (TB) are rare in developed countries. TB is the main etiology of chronic pericarditis in developing countries, but it's epidemiology is not unknown in the United States. Methods: This retrospective study used the Healthcare Utilization Projects/Nationwide Inpatient Sample (HCUPS/NIS) database from 2002-2014 to evaluate the characteristics, risk factors, trends over time and region of tuberculous pericarditis in the United States. Results: The data during the study period consists of 100,790,900 discharges accounting for 482,872,274 weighted discharges. The data showed 744 weighted discharges with indication of both tuberculosis and pericarditis. A co-ocurrence of TB pericarditis and malignancy or chronic kidney disease was more common than in patients without TB pericarditis. The frequency of co-ocurrence of TB pericarditis and HIV infection, obesity, alcohol abuse and organ transplant was not elevated. Conclusion: TB pericarditis is rare disease in the USA and the classical risk factors for lung tuberculosis may not be associated with TB pericarditis. CKD and malignancy appear to be associated with TB pericarditis, further studies are required to determine causality.

Use of Main Renal Artery Clamping Predominates Over Minimal Clamping Techniques During Robotic Partial Nephrectomy for Complex Tumors.

INTRODUCTION: Hilar clamping is often performed to facilitate robotic partial nephrectomy (RPN). Minimal clamping techniques may reduce renal ischemia, including early unclamping, selective clamping, and off-clamp RPN. We assess the utilization of clamping techniques in a large international consortium of surgeons performing RPN for complex tumors. METHODS: We retrospectively evaluated 721 patients with complex tumors, who underwent RPN at 11 centers worldwide between 2008 and 2014. Complex tumors were defined as renal masses with a nephrometry score >6. Total clamping was defined as complete clamping of the main renal artery. Minimal clamping techniques included early unclamping, selective clamping, and off-clamp RPN. Clamping techniques were additionally assessed in patients with estimated glomerular filtration rate (eGFR) <60 and in patients with a solitary kidney. Two-tailed t-tests (p < 0.05) were used to statistically analyze differences in mean warm ischemia time (WIT). RESULTS: Most patients underwent complete clamping (75.1%). Minimal clamping (24.9%) included early unclamping (10.8%), selective clamping (8.7%), and off-clamp (5.4%). Mean WIT of total clamping, selective clamping, and early unclamping was 22.2, 21.2, and 17.3 minutes, respectively. Of patients with an eGFR <60 (n = 90), 26.6% underwent minimal clamping, including 15.5% early unclamping, 4.4% selective clamping, and 6.7% off-clamp. Of patients with solitary kidneys (n = 12), 10 (83%) were performed with total clamping with mean WIT of 14.9 minutes. CONCLUSIONS: In this large international series of RPN for complex tumors, most patients underwent total clamping of the main renal artery. Minimal clamping techniques, including early unclamping, selective clamping, and off-clamp techniques, were used in a minority of cases. There was no significant increase in use of minimal clamping, even in patients with chronic kidney disease or solitary kidneys. However, mean WIT was low (<23 minutes) in all patient groups.

Quality of life outcomes in peri-urethral calcium hydroxylapatite injection.

INTRODUCTION AND HYPOTHESIS: Peri-urethral calcium hydroxylapatite injection is an established treatment for patients with stress urinary incontinence. Information is limited regarding calcium hydroxylapatite treatment and quality of life (QOL) outcomes. We hypothesize that patients might improve QOL after peri-urethral calcium hydroxylapatite injection, which was reflected in validated questionnaires. METHODS: The peri-urethral calcium hydroxylapatite injection billing code was used to identify patients who underwent injection from 2011-2013. Female patients who completed the American Urological Association Symptom Score (AUASS), the AUASS QOL and Michigan Incontinence Symptom Index (M-ISI), and the bother score (M-ISI bother), or pad count at baseline and follow-up were included. Change in questionnaire scores and pads were assessed using the paired t test. RESULTS: Sixty patients underwent 1 (30), 2 (63) or 3 (7 %) peri-urethral calcium hydroxylapatite injections performed by a single surgeon. Thirty-seven patients provided questionnaires and 38 provided pad counts, all with a mean age of 75 years. The overall AUASS, AUASS QOL, and overall M-ISI scores improved in 67.6, 54.8, and 61.3 % respectively (4.5 ± 7.9, 1.3 ± 1.7 and 5.5 ± 8.6 respectively). The M-ISI bother score improved in 44.8 % with a mean improvement of 0.5 ± 2.9, but did not reach significance. There was a 1.7 ± 3.7 decrease in the mean number of pads used daily after the procedure (p = 0.006) and 19 % experienced transient urinary retention. CONCLUSIONS: Peri-urethral calcium hydroxylapatite injections can improve urinary QOL scores in patients with initial and recurrent stress urinary incontinence. This short-term retrospective analysis suggests that larger long-term studies focusing on QOL outcomes are needed to evaluate the effect of peri-urethral calcium hydroxylapatite has on incontinence-specific QOL.

Intermediate-term cancer control outcomes in prostate cancer patients treated with robotic-assisted laparoscopic radical prostatectomy: a multi-institutional analysis.

PURPOSE: Cancer control outcomes following robot-assisted radical prostatectomy (RARP) for prostate cancer (PCa) remain inadequately addressed over intermediate-term (≥5-year) follow-up. We examined biochemical recurrence-free survival (BCRFS), clinical recurrence-free survival (CRFS), and cancer-specific survival (CSS) in a multi-institutional cohort of men undergoing RARP for localized PCa. MATERIALS AND METHODS: A total of 5670 PCa patients undergoing RARP ± pelvic lymph node dissection as primary treatment modality at three tertiary care centers between 2001 and 2010 were analyzed. BCRFS, CRFS, and CSS were estimated using the Kaplan-Meier method. Cox proportional hazards model tested their association with available preoperative and postoperative parameters. RESULTS: 43.6 and 15.1 % of patients had D'Amico intermediate- and high-risk disease, respectively. Over a mean (median) follow-up of 56 (50.4) months, 797 men had a BCR, 78 men had CR, and 32 men died of PCa. Actuarial BCRFS, CRFS, and CSS, respectively, were 83.3, 98.6, and 99.5 % at 5-year; 76.5, 97.5, and 98.7 % at 8-year; and 73.3, 96.7, and 98.4 % at 10-year follow-ups. Only 1.7 % of patients received any adjuvant treatment. Preoperative prostate-specific antigen (PSA) and biopsy Gleason score (GS) were independent clinical predictors of BCRFS, CRFS, and CSS, while postoperatively positive surgical margin, pathological GS, pathological stage, and lymph node invasion were significantly associated with BCR and CR (all p < 0.05). CONCLUSIONS: Cancer control outcomes of RARP appear comparable to those reported for open and laparoscopic RP in previous literature, despite low overall rate of adjuvant treatment. Disease severity and preoperative PSA may aid in risk prognostication and defining postoperative follow-up protocols.

Ureteral injuries sustained during robot-assisted radical prostatectomy.

BACKGROUND AND PURPOSE: During the last decade, the annual volume of robot-assisted prostatectomies performed in the United States has risen steadily. Refinements in surgical technique, understanding of anatomy, and experience have led to more complex patients being offered surgery for management of organ-confined prostate cancer. Complication rates of robot-assisted prostatectomy have been reported in several articles; however, a paucity of data exists when evaluating ureteral injuries sustained during robot-assisted prostatectomy. No standardized universal criteria for reporting and grading of complications exists; therefore, the Martin-Donat criteria with Clavien-Dindo classification system were used to evaluate ureteral injuries in our series. PATIENTS AND METHODS: From January 2001 to June 2013, 6442 consecutive patients were treated with robot-assisted prostatectomy at the same institution by one of five surgeons. All complications were documented through a prospectively maintained prostate cancer database with supplementation from electronic medical records, operative and nursing notes, claims data, discharge summaries, outpatient and emergency visits, institutional morbidity and mortality data, as well as National Surgical Quality Improvement Program data. The Martin-Donat criteria were used to facilitate the accurate and comprehensive reporting of surgical complications while complication severity was assigned following the Clavien-Dindo classification system. RESULTS: Three patients sustained ureteral injuries (ureteral transection) in our series. Both surgeons were beyond their learning curve (greater than 1000 cases) when the injuries occurred; one patient needed readmission, and all patients had risk factors predisposing them to ureteral injury. Each patient was managed with robot-assisted ureteroneocystostomy (1), open transureteroureterostomy (1) and robot-assisted ureteroureterostomy (1) respectively. CONCLUSIONS: Ureteral injuries are uncommon; however, thorough preoperative evaluation and surgical planning could identify patients at high risk for sustaining ureteral injury during prostatectomy. Measures can be taken preoperatively or intraoperatively to reduce the probability of ureteral injury, eliminating the necessity for additional procedures postoperatively.

Oncological outcomes after robot-assisted radical prostatectomy: long-term follow-up in 4803 patients.

OBJECTIVE: To evaluate oncological outcomes in patients undergoing robot-assisted radical prostatectomy (RARP) at a high-volume tertiary centre with focus on biochemical recurrence (BCR); previous studies on oncological outcomes for patients undergoing RARP for prostate cancer are limited to small series. PATIENTS AND METHODS: In all, 5152 consecutive patients underwent RARP from 2001 to 2010; 4803 patients comprised the study cohort after exclusions. BCR was defined as a serum prostate-specific antigen (PSA) level of ≥0.2 ng/mL with a confirmatory value. BCR-free survival (BCRFS), metastasis-free survival (MFS) and cancer-specific survival (CSS) were estimated using the Kaplan-Meier method and Cox hazards regression models were generated. RESULTS: The mean preoperative PSA level was 6.1 ng/mL, pathological Gleason grade and stage were ≥7 in 68% and ≥pT3 in 34% of patients. There was BCR in 470 patients (9.8%), 31 patients developed metastatic disease (0.7%) and 13 patients died from prostate cancer (0.3%) during a mean (range) follow-up of 34.6 (1-116.7) months. Actuarial 8-year BCRFS, MFS and CSS were 81%, 98.5% and 99.1%, respectively. In patients with node-positive disease, actuarial 5-year BCRFS, MFS, and CSS were 26%, 82%, and 97%. For organ-confined disease, predictors of BCR included pathology Gleason grade (primary Gleason 5 vs 3, hazard ratio [HR] 5.52, P = 0.018; Gleason 4 vs 3, HR 1.97, P = 0.001), preoperative PSA level (10-20 vs ≤10 ng/mL, HR 2.38, P = 0.001), and surgical margin status (positive vs negative, HR 3.84, P < 0.001) CONCLUSIONS: RARP appears to confer effective long-term biochemical control. To our knowledge, this is the largest report of oncological outcomes in a RARP series to date.

Long-term functional urinary outcomes comparing single- vs double-layer urethrovesical anastomosis: two-year follow-up of a two-group parallel randomized controlled trial.

OBJECTIVES: To evaluate long-term urinary outcomes in participants of a two-group randomized clinical trial comparing continence after robotic prostatectomy (RP) between those who had reconstruction of the rhabdosphincter and puboprostatic collar (double-layer anastomosis) with those who had not. METHODS: Consecutive patients (n = 116) undergoing RP at a single institution were randomized to either single- or double-layer urethrovesical (UV) anastomosis between August and December of 2007. Patients were contacted an average of 23.5 months postoperatively. A survey was performed by a third-party assessor blinded to the intervention, to evaluate urinary outcomes by International Prostate Symptom Score (IPSS), pad usage, and pad weight for those with persistent incontinence. RESULTS: Follow-up at 2 years was 86.5%. There was no statistically significant difference in demographic or preoperative functional variables between groups. There was no difference between groups regarding urine leakage weights, pad usage rates, long-term IPSS score, or IPSS bother score. Both patients in the cohort with incontinence and both with bladder neck contracture (requiring a single dilation) were in the single-layer UV anastomosis group (not significant), yet these patients had not experienced an anastomotic leak at one week. CONCLUSIONS: Long-term functional urinary outcomes were excellent for patients undergoing RP with either single- or double-layer UV anastomosis. IPSS scores and pad usage rates and weights were equivalent between groups. Although patients with single-layer anastomoses were more likely to have a leak at one-week cystogram and longer duration of catheter placement, this did not lead directly to bladder neck contracture or incontinence.

Comorbidities, functional limitations, and geriatric syndromes in relation to treatment and survival patterns among elders with colorectal cancer.

PURPOSE: To examine patterns of colorectal cancer (CRC) treatment and survival in relation to comorbidities (COM), functional limitations (FL), and geriatric syndromes (GS). METHODS: Our study population consisted of Ohio elders diagnosed with incident invasive CRC in the period August 1999 to November 2001 and admitted to home health care (HHC) in the 30 days before or after cancer diagnosis (n = 1009). We used data from the Ohio Cancer Incidence Surveillance System, vital records, and Medicare administrative data, including the HHC Outcome and Assessment Information Set (OASIS), which includes detailed clinical data for HHC patients. Counts of COM, FL, and GS at baseline were retrieved from the OASIS. Multivariable logistic and survival models were developed to examine the association between clinical attributes and outcomes, adjusting for demographic covariates and cancer stage. RESULTS: Comorbidities were associated with increased likelihood of surgery-only, but not with surgery + chemotherapy. Both FL and GS were associated with lower likelihood to undergo surgery-only or surgery + chemotherapy. Two or more GS was associated with disease-specific mortality (adjusted hazard ratio [AHR]: 2.71; 95% confidence interval [CI]: 1.80-4.07) and overall mortality (AHR: 2.34; 95% CI: 1.74-3.15). Two or more FL was associated with overall mortality (AHR: 1.33; 95% CI: 1.10-1.62), but not with disease-specific mortality. COM was not associated with overall mortality, but was negatively associated with disease-specific mortality at borderline level of significance (AHR: 0.78; 95% CI: 0.61-1.00). CONCLUSION: Our findings demonstrate the importance of accounting for FL and GS, in addition to COM, when studying cancer-related outcomes in elders.

Methodological quality in medical evidence, quo vadis?

Efforts in research quality have led to a diffusion of publication guidelines for high-quality reporting of medical evidence with the aim to instill transparency to its evaluation. The maturity of this process has led to a second stage in which a surplus of scales measuring methodological quality is in place. However, there is no clear consensus as to which of these guidelines should be recommended for usage and how to integrate the methodological quality information into the evidence synthesis process. One major challenge that these scales poses is the fact that slight modifications performed to them in order to adapt to a specific research and/or management question requires revalidation of the scale's properties, a clearly impractical endeavor. This article proposes a potential alternative to this challenge through the formulation of a framework in which quality elements are divided into tiers. This layering aims at separating quality constructs that should be uniformly present across all studies and thus could be validated from constructs that are question-specific and less likely to undergo a formal validation process. An example of this framework applied to the urological literature is presented.

Characteristics of genomic instability in clones of TK6 human lymphoblasts surviving exposure to 56Fe ions.

Genomic instability in the human lymphoblast cell line TK6 was studied in clones surviving 36 generations after exposure to accelerated 56Fe ions. Clones were assayed for 20 characteristics, including chromosome aberrations, plating efficiency, apoptosis, cell cycle distribution, response to a second irradiation, and mutant frequency at two loci. The primary effect of the 56Fe-ion exposure on the surviving clones was a significant increase in the frequency of unstable chromosome aberrations compared to the very low spontaneous frequency, along with an increase in the phenotypic complexity of the unstable clones. The radiation-induced increase in the frequency of unstable chromosome aberrations was much greater than that observed previously in clones of the related cell line, WTK1, which in comparison to the TK6 cell line expresses an increased radiation resistance, a mutant TP53 protein, and an increased frequency of spontaneous unstable chromosome aberrations. The characteristics of the unstable clones of the two cell lines also differed. Most of the TK6 clones surviving exposure to 56Fe ions showed unstable cytogenetic abnormalities, while the phenotype of the WTK1 clones was more diverse. The results underscore the importance of genotype in the characteristics of instability after radiation exposure.