Development and validation of a preoperative nomogram for predicting positive surgical margins after laparoscopic radical prostatectomy.

BACKGROUND: Positive surgical margins are independent risk factor for biochemical recurrence, local recurrence, and distant metastasis after radical prostatectomy. However, limited predictive tools are available. This study aimed to develop and validate a preoperative nomogram for predicting positive surgical margins after laparoscopic radical prostatectomy (LRP). METHODS: From January 2010 to March 2016, a total of 418 patients who underwent LRP without receiving neoadjuvant therapy at Peking University Third Hospital were retrospectively involved in this study. Clinical and pathological results of each patient were collected for further analysis. Univariable and multivariable logistic regression (backward stepwise method) were used for the nomogram development. The concordance index (CI), calibration curve analysis and decision curve analysis were used to evaluate the performance of our model. RESULTS: Of 418 patients involved in this study, 142 patients (34.0%) had a positive surgical margin on final pathology. Based on the backward selection, four variables were included in the final multivariable regression model, including the percentage of positive cores in preoperative biopsy, clinical stage, free prostate specific antigen (fPSA)/total PSA (tPSA), and age. A nomogram was developed using these four variables. The concordance index (C-index) of the nomogram was 0.722 in the development cohort and 0.700 in the bootstrap validations. The bias-corrected calibration plot showed a limited departure from the ideal line with a mean absolute error of 2.0%. In decision curve analyses, the nomogram showed net benefits in the range from 0.2 to 0.7. CONCLUSION: A nomogram to predict positive surgical margins after LRP was developed and validated, which could help urologists plan surgical procedures.

[Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction].

OBJECTIVE: To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED. METHODS: We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events. RESULTS: No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (ï¼»47.2±11.32ï¼½ yr vs ï¼»46.67±13.08ï¼½ yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control. CONCLUSIONS: China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.

[Technical improvement of transumbilical laparoendoscopic single-site nephrectomy].

OBJECTIVE: To summarize the technical modification and experiences of transumbilical laparoendoscopic single-site nephrectomy (LESS-N) by homemade device. METHODS: The clinical data of LESS nephrectomy performed from June 2010 to April 2013 in Peking University Third Hospital were analyzed retrospectively. All the cases were divided into two groups according to the technique method and operative date. Group 1 included 10 cases that underwent LESS radical nephrectomy and 2 that received LESS simple nephrectomy from June 2010 to April 2011. Group 2 included 7 cases that underwent LESS radical nephrectomy and 3 that received LESS simple nephrectomy from May 2011 to April 2013. The data on the general presentation, tumor size, tumor location, operative time, blood loss, complications, Visual Analog Pain Scale (VAPS), postoperative hospital stay, pathological results were collected to compare between the two groups. The modified technique included homemade single-ring glove technique, fast access to the pedicle, pulling-up technique to retract the kidney or liver. The kidney was dissociated after the renal vessel was cut off and extracted through the umbilical incision. RESULTS: All the procedures were finished without conversion to open radical nephrectomy. Compared with group 1, operative time showed significant difference in group 2 [Group 1:(220.6±51.0) min; Group 2: (178.9±34.0) min; P=0.04],and no difference was noted in other factors (P>0.05). There was no secondary bleeding, wound infection, intestinal obstruction, incision hernia and other severe postoperative complications. follow-up of 2 to 36 months showed no local recurrence. CONCLUSION: Transumbilical LESS-N is feasible, effective and safe. It gives a more mini-invasive and cosmetic option for young or female patients. Learning curve and operative time can be reduced by modified techniques, such as single-ring glove technique and pulling-up technique.