Effectiveness and complications during the learning curve of Thulep: Short and medium term outcomes of the first 48 procedures

MATERIALI E METODI: Tra il 2012 e il 2013, abbiamo analizzato in uno studio prospettico i dati di 48 pazienti sottoposti a ThuLEP con approccio autodidatta. I pazienti sono stati rivalutati a 3, 6, 12 e 24 mesi con la valutazione del PSA, il residuo post-minzionale (RPM), l'uroflussometria (Qmax), l'ecografia transrettale e questionari validati (IPSS: international prostate symptom score e QoL: quality of life) RISULTATI: Il volume medio della prostata è di 63 ± 5,3 ml. Il tempo operatorio medio è stato di 127,58 ± 28.50 minuti. Il peso medio del tessuto asportato è stato di 30,40 ± 13,90 gr. A 6 mesi dopo l'intervento l'RPM medio è diminuito da 165,13 ± 80,15 ml a 7,78 ± 29.19 ml, mentre il Qmax medio è aumentato da 5.75 ± 1.67ml / s a 18.1 ± 5.27 ml / s. I valori medi dei IPSS e QoL hanno dimostrato un progressivo miglioramento: da 19.15 (IQR: 2-31) e 4 (IQR: 1-6) nel preoperatorio a 6.04 (IQR: 1-20) e 1.13 (IQR: 1-4), rispettivamente. Durante la curva di apprendimento si è assistito ad un progressivo aumento del peso del tessuto enucleato e ad una progressiva riduzione del tempo di ospedalizzazione e di cateterismo. Tra le principali complicanze ricordiamo un tasso di incontinenza transitoria del 12,5% a 3 mesi e del 2.1% a 12 mesi. CONCLUSIONI: ThuLEP rappresenta una tecnica chirurgica efficace, sicura e riproducibile indipendentemente dalle dimensioni della prostata. I nostri dati suggeriscono che la ThuLEP offre un miglioramento significativo dei parametri funzionali comparabili con le tecniche tradizionali, nonostante una lunga curva di apprendimento.MATERIALS AND METHODS: Between 2012 and 2013, we prospectively analyzed the data of the first 48 patients who underwent Thulium Laser enucleation of the prostate (ThuLEP). Patients were reassessed at 3, 6, 12 and 24 months with evaluation of the PSA, post-void volume (PVR), uroflowmetry (Qmax), transrectal ultrasonography and validated questionaires (IPSS: International Prostate Symptom Score and QoL: Quality of Life). RESULTS: The mean volume of the prostate was 63 ± 5.3 ml. The mean operative time was 127.58 ± 28.50 minutes. The mean weight of the removed tissue was 30.40 ± 13.90 gr. At 6 month follow up, the mean PVR decreased from 165.13 ± 80.15 ml to 7.78 ± 29.19 ml, while the mean Qmax flow rate increased from 5.75 ± 1.67 ml/s to 18.1 ± 5:27 ml/s. The mean IPSS and QoL showed a steady improvement from 19.15 (IQR: 2-31) and 4 (IQR: 1-6) preoperatively to 6.04 (IQR: 1-20) and 1.13 (IQR: 1-4) respectively. During the learning curve, the weight of the enucleated tissue, the time of hospital stay and the catheter time improved significantly. The main complications included transient stress incontinence (12.5% ​​at 3 months and 2.1% at 12 months). CONCLUSIONS: ThuLEP is an effective, safe and reproducible surgical technique, regardless of the prostate size. Our data suggest that ThuLEP offers a significant improvement in functional outcomes comparable with traditional techniques despite a long learning curve

Molecular diagnostic tools for the detection of nodal micrometastases in prostate cancer patients undergoing radical prostatectomy with extended pelvic lymph node dissection: a prospective study

BACKGROUND: Routine pathological examination can miss micro-metastatic tumor foci in the lymph nodes (LN) of patients with prostate cancer (PCa) that undergo radical prostatectomy and pelvic lymph node dissection (PLND). The aim of the present prospective study was to evaluate the impact of micrometastases assessed by serial section (SS), immunohistochemistry (IHC), and Real-time Polymerase Chain Reaction (RT-PCR) in patients undergoing radical prostatectomy with extended PLND. MATERIALS AND METHODS: 32 consecutive patients who underwent radical prostatectomy with extended PLND (obturator, internal/external and distal 2 cm common iliac lymph-nodes (LN)) for intermediate (clinical T1c-T2 and PSA:10-20 ng/mL and clinical Gleason Score = 7) or high (clinical stage T3 or PSA>20 or clinical Gleason Score = 8-10) PCa were enrolled. The nodes were processed by the one uropathologist, both according to the routine pathological examination (analysis of the central section for 4 mm nodes or every 2 mm for LN>4 mm), which served as comparative method, both according to SS, IHC with antibodies against PSA and broad-spectrum Cytokeratins (BSCK), and quantitative RT-PCR targeting PSA, PSMA (PS Membrane Antigen), and Glucuronidase-S-Beta (GUSB) mRNA, that are over-expressed in prostatic cancer cells. RESULTS: A total of 628 LN were analyzed, with a mean number of LN removed of 19.6 (SD = 7.2). Applying the routine pathological examination, 10 (31.2%) patients and 23 (3.9%) LN resulted positive for nodal involvement, with mean positive LN of 2.2 (SD = 1.4). After applying the SS and the molecular method of analysis (IHC and RT-PCR), micrometastases were found in 7 LN (SS showed micrometastases in 3 of them, IHC in 6 of them and RT-PCR in 7 of them); a total of 3 (9.3%) node-negative patients showed micrometastases at routine pathological examination (in 2 patients with RT-PCR and in 1 with IHC). CONCLUSIONS: The significance of micrometastases in PCa and the potential therapeutic role of PLND is not yet clarified, but the molecular analysis of the LN can detect a significant percentage of patients who harbor micro-metastatic PCa missed at routine pathological examination, and can enhance the accuracy of lymphadenectomy as a staging method

Holmium laser prostatectomy in a tertiary Italian center: A prospective cost analysis in comparison with bipolar TURP and open prostatectomy

Objective: To assess the economic impact of Holmium laser enucleation of prostate (HoLEP) in comparison with transurethral resection of prostate (TURP) and open prostatectomy (OP). Methods: Between January 2017 and January 2018, we prospectively enrolled 151 men who underwent HoLEP, TURP or OP at tertiary Italian center, due to bladder outflow obstruction symptoms. Patients with prostate volume ≤ 70 cc and those with prostate volume > 70 cc were scheduled for TURP or HoLEP and OP or HoLEP, respectively. Intraoperative and early post-operative functional outcomes were recorded up to 6 months follow up. Cost analysis was carried out considering direct costs (operating room [OR] utilization costs, nurse, surgeons and anesthesiologists' costs, OR disposable products costs and OR products sterilization costs), indirect costs (hospital stay costs and diagnostics costs) and global costs as sum of both direct and indirect plus general costs related to hospitalization. Cost analysis was performed comparing patients referred to TURP and HoLEP with prostate volume ≤ 70 cc and men underwent OP and HoLEP with prostate volume > 70 cc respectively. Results: Overall, 53 (35.1%), 51 (33.7%) and 47 (31.1%) were scheduled to HoLEP, TURP and OP, respectively. Both TURP, HoLEP and OP proved to effectively improve urinary symptoms related to BPE. Considering patients with prostate volume ≤ 70 cc, median global cost of HoLEP was similar to median global cost of TURP (2151.69 € vs. 2185.61 €, respectively; p = 0.61). Considering patients with prostate volume > 70 cc, median global cost of HoLEP was found to be significantly lower than median global cost of OP (2174.15 € vs. 4064.97 €, respectively; p ≤ 0.001). Conclusions: Global costs of HoLEP are comparable to those of TURP, offering a cost saving of only 11.4 € in favor of HoLEP. Conversely, HoLEP proved to be a strong competitor of OP because of significant global cost sparing amounting to 1890.82 € in favor of HoLEP

Small renal masses initially managed using Active surveillance: Results from a retrospective study with long-term follow-up

Background The purpose of the study was to evaluate the relationships between the patients' clinical characteristics and the growth pattern of SRMs, and to investigate the predictive factors of tumor growth rates in patients initially managed with AS. Materials and Methods We retrospectively reviewed data from our prospectively collected database of 70 patients diagnosed with 72 SRMs between 1996 and 2013. Clinical and demographic data, and linear and volumetric growth rates were recorded for each patient. A Pearson correlation test was used to evaluate initial tumor size and linear or volumetric growth rate. Logistic regression models were used to evaluate the predictive factors affecting tumor growth kinetics. Results The mean age was 76 \ub1 6.8 years, and 47 (67.1%) of patients were male. The mean (\ub1 SD) and the median (interquartile range [IQR]) tumor size at presentation were 2.1 \ub1 1.3 and 2.7 (1.8-3.7) cm, respectively. The mean (\ub1 SD) and the median (IQR) linear growth rate were 0.5 \ub1 0.3 and 0.6 (0.4-1.5) cm per year, respectively. Patients treated with delayed surgery experienced a significantly greater mean linear growth rate (1.4 vs. 0.3 cm per year) than those observed in the AS group (P <.001). Male sex (HR, 1.70; P =.04) and symptomatic presentation (HR, 1.85; P =.02) were found to be significant predictors of tumor growth rates during AS. Conversely, age, Charlson Comorbidity Index, and initial tumor size failed to predict growth kinetics. Conclusion Male sex and symptomatic presentation are associated with faster growth rates in patients managed with AS after long-term follow-up

Small Renal Masses Managed With Active Surveillance: Predictors of Tumor Growth Rate After Long-Term Follow-Up.

Background The purpose of the study was to evaluate the relationships between the patients' clinical characteristics and the growth pattern of SRMs, and to investigate the predictive factors of tumor growth rates in patients initially managed with AS. Materials and Methods We retrospectively reviewed data from our prospectively collected database of 70 patients diagnosed with 72 SRMs between 1996 and 2013. Clinical and demographic data, and linear and volumetric growth rates were recorded for each patient. A Pearson correlation test was used to evaluate initial tumor size and linear or volumetric growth rate. Logistic regression models were used to evaluate the predictive factors affecting tumor growth kinetics. Results The mean age was 76 ± 6.8 years, and 47 (67.1%) of patients were male. The mean (± SD) and the median (interquartile range [IQR]) tumor size at presentation were 2.1 ± 1.3 and 2.7 (1.8-3.7) cm, respectively. The mean (± SD) and the median (IQR) linear growth rate were 0.5 ± 0.3 and 0.6 (0.4-1.5) cm per year, respectively. Patients treated with delayed surgery experienced a significantly greater mean linear growth rate (1.4 vs. 0.3 cm per year) than those observed in the AS group (P <.001). Male sex (HR, 1.70; P =.04) and symptomatic presentation (HR, 1.85; P =.02) were found to be significant predictors of tumor growth rates during AS. Conversely, age, Charlson Comorbidity Index, and initial tumor size failed to predict growth kinetics. Conclusion Male sex and symptomatic presentation are associated with faster growth rates in patients managed with AS after long-term follow-up

The impact of a structured intensive modular training in the learning curve of robot assisted radical prostatectomy

Aim: The success of Robot Assisted Laparoscopic Prostatectomy (RALP) is mainly due to his relatively short learning curve. Twenty cases are needed to reach a “4 hours-proficiency”. However, to achieve optimal functional outcomes such as urinary continence and potency recovery may require more experience. We aim to report the perioperative and early functional outcomes of patients undergoing RALP, after a structured modular training program. Methods: A surgeon with no previous laparoscopic or robotic experience attained a 3 month modular training including: a) e-learning; b) assistance and training to the operating table; c) dry console training; d) step by step in vivo modular training performing 40 surgical steps in increasing difficulty, under the supervision of an experienced mentor. Demographics, intraoperative and postoperative functional outcomes were recorded after his first 120 procedures, considering four groups of 30 cases. Results: All procedures were completed successfully without conversion to open approach. Overall 19 (15%) post operative complications were observed and 84% were graded as minor (Clavien I-II). Overall operative time and console time gradually decreased during the learning curve, with statistical significance in favour of Group 4. The overall continence rate at 1 and 3 months was 74% and 87% respectively with a significant improvement in continence rate throughout the four groups (p = 0.04). Considering those patients submitted to nerve-sparing procedure we found a significant increase in potency recovery over the four groups (p = 0.04) with the higher potency recovery rate up to 80% in the last 30 cases. Conclusions: Optimal perioperative and functional outcomes have been attained since early phase of the learning curve after an intensive structured modular training and less than 100 consecutive procedures seem needed in order to achieve optimal urinary continence and erectile function recovery