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185 result(s) for "Fritsche, H. M."
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Risk stratification of pT1-3N0 patients after radical cystectomy for adjuvant chemotherapy counselling
Background: In pT1-T3N0 urothelial carcinoma of the bladder (UCB) patients, multi-modal therapy is inconsistently recommended. The aim of the study was to develop a prognostic tool to help decision-making regarding adjuvant therapy. Methods: We included 2145 patients with pT1-3N0 UCB after radical cystectomy (RC), naive of neoadjuvant or adjuvant therapy. The cohort was randomly split into development cohort based on the US patients ( n =1067) and validation cohort based on the Europe patients ( n =1078). Predictive accuracy was quantified using the concordance index. Results: With a median follow-up of 45 months, 5-year recurrence-free and cancer-specific survival estimates were 68% and 73%, respectively. pT-stage, ge, lymphovascular invasion, and positive margin were significantly associated with both disease recurrence and cancer-specific mortality ( P -values⩽0.005). The accuracies of the multivariable models at 2, 5, and 7 years for predicting disease recurrence were 67.4%, 65%, and 64.4%, respectively. Accuracies at 2, 5, and 7 years for predicting cancer-specific mortality were 69.3%, 66.4%, and 65.5%, respectively. We developed competing-risk, conditional probability nomograms. External validation revealed minor overestimation. Conclusion: Despite RC, a significant number of patients with pT1-3N0 UCB experience disease recurrence and ultimately die of UCB. We developed and externally validated competing-risk, conditional probability post-RC nomograms for prediction of disease recurrence and cancer-specific mortality.
Long-term outcome after grafting with small intestinal submucosa and collagen fleece in patients with Peyronie's disease: a matched pair analysis
Advanced Peyronie's disease (PD) with severe penile curvature requires grafting following plaque incision or partial plaque excision. So far, the ideal graft material has not been identified although various grafts have been studied. In this first matched pair analysis we compared the outcome after grafting with small intestinal submucosa (SIS) and self-adhesive collagen fleece (CF). We retrospectively identified 43 patients after SIS grafting with complete follow-up data sets to be eligible for the present study. A total of 43 patients after CF grafting were matched case by case to the SIS group using the degree of preoperative penile curvature as the primary matching factor. Postoperative outcome was compared with the focus on penile straightening, penile length, potency, relapse rates and long-term complications. Median degree of curvature was 80° in each group. Mean follow-up periods were 31 months after SIS and 39 months after CF grafting. The CF grafting procedure was significantly faster than SIS grafting (80 vs. 104 min, p < 0.001). No major short-term complications were observed. Both techniques gained good long-term penile straightening rates. Relapse of penile curvature was observed after SIS grafting only. Postoperative penile shortening occurred more often after SIS grafting (28% vs. 5%, p = 0.007). With a mean preoperative IIEF-5 score of 16, the SIS cohort significantly differed from the CF cohort with a mean IIEF-5 score of 19 (p = 0.016). The median IIEF-5 score improvement was higher after SIS grafting (+4.5 vs. +1, p = 0.002). Diminished penile sensation was the main long-term side effect with low rates after both procedures (9% and 7% in the SIS and CF group respectively, p = 0.100). In this first matched pair analysis both techniques showed promising long-term results. CF seems to have advantages regarding duration of surgery and preserving penile length. More comparative studies with larger collectives are desirable.
Potentially clinically relevant prostate cancer is found more frequently after complete than after partial histopathological processing of radical cystoprostatectomy specimens
Incidental prostate cancer is often found in cystoprostatectomy specimens. The presence of a clinically significant tumour has an impact on follow-up strategies. In prostatectomy specimen for prostate cancer, whole-mount sections improve diagnostic accuracy. The present study compares detection of incidental prostate cancer in complete to routine processing. We included 295 consecutive patients who underwent radical cystoprostatectomy. Between 01/1995 and 12/2003 (period I), specimens of 129 patients were partially processed, whereas between 01/2004 and 03/2009 (period II), specimens of 166 patients were completely processed. Incidental prostate cancer was detected overall in 91 (30.8 %) patients. Prostate cancer was detected in 24 (18.6 %) patients in period 1 and in 67 (40.4 %) patients in period 2 ( p  < 0.001). Potentially clinically significant prostate cancer was detected in 12 (9.2 %) and 29 (17.5 %) patients, respectively ( p  = 0.044). Complete embedding and processing of cystoprostatectomy specimen yield significantly more potentially clinically relevant prostate cancers. The present data suggest that notably in younger men the specimens should be completely processed.
Positive urine cytology and carcinoma in situ prior to second transurethral resection of the bladder correlate with positive second resection histology and the need for subsequent cystectomy
Objective A second transurethral resection of the bladder (TURB) is recommended for high-grade bladder cancer (BC) yet yields negative results in over half of the cases. Aim of this study was to identify prognostic indicators of a positive second TURB or the need for a subsequent cystectomy. Materials and methods The study cohort consisted of 101 patients with high-risk BC (T1G2-3, TaG3, Carcinoma in situ ) who underwent second TURB after complete first resection. Age, gender, stage, grade, carcinoma in situ (Cis) , tumour number, size, localization, surgeon experience and bladder wash cytology before the second TURB were considered as potential prognostic factors of positive histology at second TURB or the need for subsequent cystectomy. Results The mean follow-up period was 23.8 months. The study cohort was comprised of 82 males and 17 females. Cytology on bladder wash urine was performed in 85/101 patients and in 39 was negative; 55.5 % of second TURB specimens were negative. The rate of upstaging to ≥T2 was 4.9 %. Cis (OR 8.4; 95 % CI 1.3–54.2; p  = 0.03) and positive cytology (OR 6.8; 95 % CI 2.3–19.9; p  = <0.01) were independent prognostic factors of a residual tumour in the second TURB. Cytology also correlated with clinical need for cystectomy in the follow-up (HR 6.5; 95 % CI 1.3–30.5; p  = 0.02). Conclusions CIS and positive cytology prior to second TURB increased the risk of a positive second TURB specimen. A positive cytology also increases the risk of the subsequent need for cystectomy.
The HELENA study: Hexvix®-TURB vs. white-light TURB followed by intravesical adjuvant chemotherapy—a prospective randomized controlled open-label multicenter non-inferiority study
PurposePhotodynamic diagnosis and white-light TURB with adjuvant intravesical chemotherapy (ICT) is widely used in treatment of bladder cancer. This non-inferiority trial is designed to demonstrate non-inferiority regarding recurrence-free survival (RFS) of Hexvix® TURB followed by immediate instillation compared to white-light TURB with immediate instillation followed by maintenance ICT.MethodsBetween 07/2010 and 12/2016, 129 patients with EORTC intermediate risk non-muscle invasive bladder cancer treated with TURB were included in this multicentre phase III study. Patients were randomized and received either white-light TURB with immediate ICT followed by maintenance ICT (n = 62, 20 mg Mitomycin weekly for 6 weeks as induction phase, afterwards 20 mg/month for 6 months) or Hexvix® TURB with immediate ICT only (n = 67, 40 mg Mitomycin). Primary study endpoint was RFS after 12 months. Hexvix® TURB was counted as non-inferior to white light alone if the upper limit of the one-sided 95% confidence interval of hazard ratio was lower than 1.676. Due to the non-inferiority design, the per-protocol population was used as the primary analysis population (n = 113)ResultsMedian follow-up was 1.81 years. Hexvix® group showed more events (recurrence or death) than white-light group (19 vs. 10) resulting in a HR of 1.29 (upper limit of one-sided 95%-CI = 2.45; pnon-inferiority = 0.249). The ITT population yielded similar results (HR = 1.67); 3.18], pnon-inferiority = 0.493). There was no significant difference in overall survival between both groups (p = 0.257).ConclusionNon-inferiority of Hexvix® TURB relative to white-light TURB with maintenance Mitomycin instillation in intermediate risk urothelial carcinoma of the bladder was not proven. Hence a higher effect of maintenance ICT is to assume compared to a Hexvix®-improved TURB only, confirming its important role in patient treatment.
Miniaturized percutaneous Nephrolithotomy without antibiotic prophylaxis: a single institution experience
Purpose To assess the feasibility of sparing routine antibiotic prophylaxis in patients without preoperative urinary tract infection (UTI) undergoing a miniaturized percutaneous nephrolithotomy (mPCNL). Patients and Methods A retrospective, monocentric study was conducted to evaluate the outcome of a modified perioperative antibiotic management strategy according to the principles of antibiotic stewardship (ABS). From December 2015 patients undergoing mPCNL for kidney stone with preoperative unremarkable urine culture no longer received an antibiotic prophylaxis (NoPAP). The NoPAP group was compared to mPCNL patients who received standard antibiotic prophylaxis (PAP) in the two years before. Analysis focused on postoperative complications. Logistic regression analysis was performed to identify potential risk factors. Results Postoperative fever occurred in 8% of the NoPAP and 9% of the PAP patients ( p  = 0.764). Clavien 1–3 complications did not differ between groups with 33% in the NoPAP and 41% in the PAP ( p  = 0.511). No Clavien 4–5 complications were seen. A (partial) staghorn stone (HR 5.587; p  = 0.019) and an infectious stone component (HR 6.313; p  = 0.003) were identified as significant risk factors for postoperative fever. By sparing routine antibiotic prophylaxis the overall antibiotic usage was reduced from 100% (PAP) to 9% (NoPAP). Conclusion Patients with negative preoperative UC, a none-staghorn stone and no history of recurrent UTI or infectious stones may not need routine antibiotic prophylaxis prior to mPCNL. A prospective validation is warranted.
Bicentric prospective evaluation of corporoplasty with porcine small intestinal submucosa (SIS) in patients with severe Peyronie’s disease
Introduction Advanced Peyronie’s disease (PD) with severe penile deviation demands grafting procedures following plaque incision or partial plaque excision in order to avoid penile shortening and to improve quality of life of affected patients. Small intestinal submucosa (SIS) is an established xenograft. The objective of the present study was to validate external results in a bicentric prospective manner. Methods Patient selection criteria, surgical technique and standards for pre- and postoperative care were defined. Consecutively, patients with severe penile deviation in stable disease and sufficient erectile function were included between 2007 and 2015. After plaque incision, grafting was performed using SIS in a standardized manner. The postoperative evaluation using a non-validated questionnaire included complications, correction of curvature, pre- and postoperative erectile function, change in penile length and general satisfaction with the procedure. Results Forty-three patients underwent surgery between 2007 and 2015. The mean degree of preoperative curvature was 73.8° (range 60–90°). No intraoperative or major postoperative complications were reported. After a mean follow-up of 33.0 months (range 10–59), complete straightening of the penis was achieved in 74.4%. 88.4% of all patients were able to achieve satisfying sexual intercourse (67.4% unaided, 21.0% with assistance). The IIEF-5 score was improved in 69.8% (mean improvement 4.0 points). Overall 86.0% were satisfied with the surgical treatment. Conclusion Corporoplasty with SIS in patients with PD and severe penile curvature is a safe approach and shows good long-term results. A thorough patient selection and a standardized pre-, intra- and postoperative procedure are decisive for a satisfying outcome.
Preoperative anemia is associated with adverse outcome in patients with urothelial carcinoma of the bladder following radical cystectomy
Purpose Radical cystectomy (RC) can be associated with significant blood loss, whereas many patients are presenting with anemia preoperatively. To date, there is a lack of data addressing the impact of preoperative anemia (PA) on survival of patients undergoing RC for urothelial carcinoma of the bladder (UCB). Methods This retrospective multicenter study includes 684 patients with UCB undergoing RC with pelvic lymph node dissection. The median follow-up was 50 (IQR 29,78) months. Anemia was defined in line with the WHO classification (hemoglobin (Hb): male ≤13 g/dL, female ≤12 g/dL) and based on contemporary gender- and age-adjusted classification (Hb: white male aged <60 years: ≤13.7 g/dL; ≥60 years: ≤13.2 g/dL; white female of all ages ≤12.2 g/dL). Univariable and multivariable Cox regression analyses were used to assess the effects of PA on oncological outcomes. Results A total of 269 (39.3 %) and 302 (44.2 %) patients were anemic according to the WHO classification versus contemporary classification. Age, increased ECOG performance status, advanced tumor stages, lymph node metastasis, positive surgical margin and anemia were associated with disease recurrence (DR), cancer-specific mortality (CSM) and all-cause mortality (ACM). In multivariable analysis, anemia was an independent predictor of DR, CSM and ACM (WHO and/or contemporary classification). Blood transfusion was significantly associated with ACM in both classifications of anemia. Conclusions PA is significantly associated with worse oncological outcome in patients undergoing RC. Based on the additional unfavorable influence of blood transfusion, this emphasizes the importance of early diagnosis and correction of anemia and implementation of alternative methods of blood volume management.
The effect of intra- and postoperative allogenic blood transfusion on patients’ survival undergoing radical cystectomy for urothelial carcinoma of the bladder
Purpose Radical cystectomy (RC) can be associated with significant blood loss. Allogenic blood transfusion (ABT) may alter disease outcome because of a theoretical immunomodulatory effect. We evaluated the effects of ABT on overall survival (OS) and progression-free survival (PFS) of patients undergoing RC for urothelial carcinoma of the bladder (UCB). Materials and methods This is a retrospective single-center study of 350 consecutive patients of a university health center with a median follow-up of 70.1 month. All patients underwent RC and pelvic lymph node dissection. The effect of ABT on OS and PFS was analyzed using univariable and multivariable Cox proportional hazards models. Results The overall ABT rate was 63 % ( n  = 219), with intraoperative blood transfusion and postoperative blood transfusion being performed in 183 patients (52 %) and 99 patients (28 %), respectively. Preoperative anemia was detected in 156 patients (45 %) with median estimated blood loss of 800 ml (IQR: 500–1,200). ABT was associated with significant decrease of OS and PFS in multivariable analyses ( p  < 0.001), whereas patients’ prognosis worsened the more packed red blood cells (PRBC) were transfused ( p  < 0.001). The study is limited in part due to its retrospective design. Conclusions We found that ABT and the number of PRBC transfused are associated with poor prognosis for UCB patients undergoing RC, whereas preoperative anemia had no influence on survival. This emphasizes the importance of surgeon’s awareness for a strict indication for ABT. A prospective study will be necessary to evaluate the independent risks associated with ABT during surgical treatments.
Body mass index has no impact on sperm quality but on reproductive hormones levels
Summary The influence of overweight and obesity on sperm quality and reproductive hormone levels is under discussion. The aim of the present retrospective study was to evaluate the influence of body mass index (BMI) on sperm quality and reproductive hormones. We analysed semen samples and serum levels of FSH, LH, T and PRL of a total of 2110 men attending our andrology unit from 1994 to 2010 due to infertility work‐up. Patients were stratified according to their BMI in four groups. Main outcome measures were sperm motility, morphology and concentration. Serum levels of FSH, LH, T and PRL were evaluated as well. No statistically significant difference was found for sperm quality and BMI between patients categorised according to the four BMI levels. T (P < 0.001) and LH (P = 0.006) significantly differed between the four groups. In multivariable analysis, BMI did not have significantly independent influence on all assessed sperm quality parameters, whereas BMI significantly influenced hormone values for LH (P = 0.001), T (P = <0.001) and PRL (P = 0.044). We therefore conclude that BMI has no significant impact on sperm quality parameters. However, serum levels of LH, T and PRL were significantly influenced by BMI.