Validation of a Novel Cost Effective Easy to Produce and Durable In Vitro Model for Kidney-Puncture and Percutaneous Nephrolitholapaxy-Simulation.

INTRODUCTION: Nephrolithiasis is one of the most common diseases in urology. According to the EAU Guidelines, a percutaneous nephrolitholapaxy (PNL) is recommended when treating a kidney stone >2 cm. Nowadays, PNL is performed even for smaller stones (<1 cm) using miniaturized instruments. The most challenging part of any PNL is the puncture of the planned site. PNL-novice surgeons need to practice this step in a safe environment with an ideal training model. We developed and evaluated a new, easy to produce, in vitro model for the training of the freehand puncture of the kidney. MATERIALS AND METHODS: Porcine kidneys with ureters were embedded in ballistic gel. Food coloring and preservative agent were added. We used the standard imaging modalities of X-ray and ultrasound to validate the training model. An additional new technique, the iPAD-guided puncture, was evaluated. Five novices and three experts conducted 12 punctures for each imaging technique. Puncture time, radiation dose, and number of attempts to a successful puncture were measured. Mann-Whitney-U, Kruskal-Wallis, and U-Tests were used for statistical analyses. RESULTS: The sonography-guided puncture is slightly but not significantly faster than the fluoroscopy-guided puncture and the iPAD-assisted puncture. Similarly, the most experienced surgeon's time for a successful puncture was slightly less than that of the residents, and the experienced surgeons needed the least attempts to perform a successful puncture. In terms of radiation exposure, the residents had a significant reduction of radiation exposure compared to the experienced surgeons. CONCLUSION: The newly developed ballistic gel kidney-puncture model is a good training tool for a variety of kidney-puncture techniques, with good content, construct, and face validity.

European Association of Urology Section of Urolithiasis (EULIS) Consensus Statement on Simulation, Training, and Assessment in Urolithiasis.

BACKGROUND: Simulation-based training offers an acceptable adjunct to the traditional mentor-apprentice model in helping trainees to traverse the early stages of the learning curve for ureteroscopy and percutaneous renal surgery. In addition, nontechnical skills are increasingly important in preventing adverse events in the operating room, and simulation-based training can be used for training in such skills. Incorporation of simulation into formalised, standardised, and validated curricula offers an applicable method for training residents. OBJECTIVE: To develop a curriculum for urolithiasis procedures incorporating technical and nontechnical skills training for implementation across Europe. DESIGN, SETTING, AND PARTICIPANTS: An international panel of experts from EULIS, EUREP, ESU and ESUT was consulted in five stages. The study incorporated a mix of qualitative and quantitative data for collection and analysis. Responses were drawn out in (1) an opinion survey and (2) a curriculum development survey, which were discussed in (3) a focus group meeting. Group responses from this meeting were analysed for themes, which were discussed at (4) a focus group meeting, where consensus was reached among the group. Data analysis and integration at this stage were used to draft the curriculum. RESULTS AND LIMITATIONS: All group meetings were transcribed from the focus group discussion. Eight themes were generated, into which all data were categorised. These were: need for a training curriculum; curriculum objectives; curriculum structure; curriculum content; teaching platforms and tools; assessment and certification; validation and implementation; and global integration of the curriculum. A curriculum, including recommended simulators for use, was subsequently proposed. CONCLUSIONS: We propose a comprehensive curriculum for training in urolithiasis. Additional planning is required for full validation and implementation before it can be used to train residents. PATIENT SUMMARY: Stone disease accounts for a major proportion of surgical interventions worldwide. We describe a consensus guideline for effective training of stone surgeons.

Three-dimensional Technology Facilitates Surgical Performance of Novice Laparoscopy Surgeons: A Quantitative Assessment on a Porcine Kidney Model.

OBJECTIVE: To determine whether the use of 3-dimensional (3D) imaging translates into a better surgical performance of naïve urologic laparoscopic surgeons during pyeloplasty (PY) and partial nephrectomy (PN) procedures. MATERIALS AND METHODS: Eighteen surgeons without any previous laparoscopic experience were randomly assigned to perform PY and PN in a porcine model using initially 2-dimensional (2D) and 3D laparoscopy. A surgical performance score was rated by an "expert" tutor through a modified 5-item global rating scale contemplating operative field view, bimanual dexterity, efficiency, tissue handling, and autonomy. Overall surgical time, complications, subjective perception of participating surgeons, and inconveniences related to the 3D vision were recorded. RESULTS: No difference in terms if operative time was found between 2D or 3D laparoscopy for both the PY (P = .51) and the PN (P = .28) procedures. A better rate in terms of surgical performance score was noted by the tutors when the study participants were using 3D vs 2D, for both PY (3.6 [0.8] vs 3.0 [0.4]; P = .034) and PN (3.6 [0.51] vs 3.15 [0.63]; P = .001). No complications occurred in any of the procedures. Most (77.2%) of the participating naïve laparoscopic surgeons had the perception that 3D laparoscopy was overall easier than 2D. Headache (18.1%), nausea (18.1%), and visual disturbance (18.1%) were the most common issues reported by the surgeons during 3D procedures. CONCLUSION: Despite the absence of translation in a shorter operative time, the use of 3D technology seems to facilitate the surgical performance of naïve surgeons during laparoscopic kidney procedures on a porcine model.

Comparative study for evaluating the cosmetic outcome of small-incision access retroperitoneoscopic technique (SMART) with standard retroperitoneoscopy using the Observer Scar Assessment Scale: are small incisions a big deal?

AIM: To compare the scars and cosmetic results of trocars of 3, 5, and 10 mm in cases by small-incision access retroperitoneoscopic technique pyeloplasty (SMARTp) and standard laparoscopy pyeloplasty (SLp). METHODS: Between January 2012 and October 2013, 20 pyeloplasties were performed: 12 with SMARTp and 8 with SLp techniques. A 5-mm homemade balloon trocar was used to create the retroperitoneal space. In SMARTp, 3- and 5-mm trocars were used and in SLp, 5- and 10-mm trocars were used. All patients underwent a ureteral (Double-J) stent placement preoperatively. The study included a total of 72 trocar-site scars: 3 mm (24 scars), 5 mm (24 scars), and 10 mm (24 scars). Cosmetic outcome was assessed at the 3rd, 12th, and 24th month of surgeries by the Observer Scar Assessment Scale (OSAS). RESULTS: Mean age was 34.7±10.5 (19-52) years, and mean follow up was 18.7±9.2 months. Fifteen patients (75%) underwent Y-V plasty, and 5 (25%) underwent Anderson-Hynes pyeloplasty. Mean operative time was 125.4±28.7 minutes. There was only minimal blood loss, no need for conversion to standard laparoscopic or open pyeloplasty, no intraoperative complications, and only two postoperative complications were recorded: retroperitoneal hemorrhage and wound infection and both were treated conservatively. There were significant differences between objective questions of "vascularization" in a 3-mm trocar and "thickness" in a 10-mm trocar. Twenty-four months after surgery, the cosmetic data assessed by OSAS showed statistically significant differenecs in favor of the 3-mm trocar sites versus the 10-mm trocar sites (OSAS: 13.8±3.9 vs 24.6±1.7; p=0.006) with no statistically significant difference between 3- and 5-mm port sites. CONCLUSIONS: The SMARTp is proved to be an efficacious and tolerable procedure with better cosmetic results and can be used for the treatment of ureteropelvic junction obstruction (UPJO) in suitable patients. We believe that this technique is likely to become an established procedure.

Three-dimensional vs standard laparoscopy: comparative assessment using a validated program for laparoscopic urologic skills.

OBJECTIVE: To compare the last generation of 3-dimensional imaging (3D) vs standard 2-dimensional imaging (2D) laparoscopy. MATERIALS AND METHODS: A prospective observational study was conducted during the 4th Minimally Invasive Urological Surgical Week Course held in Braga (Portugal) in April 2013. The course participants and faculty were asked to perform standardized tasks in the dry laboratory setting and randomly assigned into 2 study groups; one starting with 3D, the other with 2D laparoscopy. The 5 tasks of the European Training in Basic Laparoscopic Urological Skills were performed. Time to complete each task and errors made were recorded and analyzed. An end-of-study questionnaire was filled by the participants. RESULTS: Ten laparoscopic experts and 23 laparoscopy-naïve residents were included. Overall, a significantly better performance was obtained using 3D in terms of time (1115 seconds, interquartile range [IQR] 596-1469 vs 1299 seconds, IQR 620-1723; P = .027) and number of errors (2, IQR 1-3 vs 3, IQR 2-5.5; P = .001). However, the experts were faster only in the "peg transfer" task when using the 3D, whereas naïves improved their performance in 3 of the 5 tasks. A linear correlation between level of experience and performance was found. Three-dimensional imaging was perceived as "easier" by a third of the laparoscopy-naïve participants (P = .027). CONCLUSION: Three-dimensional imaging seems to facilitate surgical performance of urologic surgeons without laparoscopic background in the dry laboratory setting. The advantage provided by 3D for those with previous laparoscopic experience remains to be demonstrated. Further studies are needed to determine the actual advantage of 3D over standard 2D laparoscopy in the clinical setting.

In-vivo assessment of barbed suturing thread with regard to tissue reaction and material absorption in a rat model.

AIM: The laparoscopic approach in urological surgery demands a high degree of skill in intracorporeal suturing and knot tying. In an effort to reduce the amount of time required to perform a suture, new materials have been developed that through selfanchorage distribute tension more evenly across the suture and also eliminate the need of knot tying. The goal of this study was to assess the in vivo tissue response to a novel material (V-Loc tm; Covidien) in comparison to established materials (Vicryl, PDS II), in the case of bladder suturing, in a rat model. METHODS: The study included 48 male Wistar rats. All underwent a median abdominal incision, with a 1cm cystotomy, followed by a running suture. The suture material used was either V-Loc absorbable self anchoring thread, Vicryl threaded absorbable suture or monofilament absorbable suture. The abdominal cavity and the bladder suture were macroscopically evaluated at the rats' scheduled death at 3 and 6 weeks. The bladder wall was microscopically assessed by a pathologist, with regard to tissue reaction and suture material degradation. RESULTS: All rats survived the procedure, with the abdominal scar fully healed at week 2. There were no signs of infection or lithiasis during the observation. Macroscopically, at 3 weeks, the suture material was recognizable and visible in all cases, with special mention that the V-Loc thread was considerably more rigid, retaining its shape almost entirely, and provoked more adhesion of the surrounding tissue. At 6 weeks, the suture was indistinguishable in the bladder wall in the case of monofilament absorbable material, barely visible in the case of Vicryl, while the aspect of the V-Loc suture resembled the one at 3 weeks, with the material still clearly visible in the bladder wall, shape almost entirely maintained, and surrounding tissue adherence. Microscopically, at 3 weeks and 6 weeks, all bladder walls examined had regained their structure. At 3 weeks, the monofilament absorbable suture showed intense tissue reaction, with the material already in phagocytosis; at 6 weeks, no clear evidence of leftover material was observed. At 3 weeks, the Vicryl material showed moderate tissue reaction, with phagocytosis initiated between the strands of the material; at 6 weeks, the material was almost entirely absorbed, but with a clear leftover tissue reaction. In the case of the V-Loc suture, due to the hardness of the thread, the material itself could not be cut for analysis with the bladder wall, and the examination could only involve the bladder wall and marks of the thread. Thus, the tissue reaction was minimal, as was the presence of phagocytes at the suture site. The material showed little, if any, signs of absorption after 6 weeks. CONCLUSION: The materials tested all proved equally effective in suturing the bladder wall in a rat model. However, the novel barbed thread proved a consistently low in-vivo absorption rate, while maintaining its rigidity over time. More research is needed to assess the possible clinical implications of these findings.

Minilaparoscopy, needlescopy and microlaparoscopy: decreasing invasiveness, maintaining the standard laparoscopic approach.

OBJECTIVES: To review the development of miniaturized laparoscopic instruments with particular attention to the urological field and focusing on nomenclature, history and outcomes. METHODS: A comprehensive literature search was conducted in order to find articles related to Minilaparoscopy, Needlescopy, Microlaparoscopy. The most relevant papers over the last 30 years were selected in base to the experience from the panel of experts, journal, authorship and /or content. RESULTS: 258 manuscripts were found, 14 of them review, 126 about general surgery, 86 gynecology, 55 urology, 31 thoracic surgery. Minilaparoscopy is the main topic in 169 papers, Needlescopy in 58 and Microlaparoscopy in 32. No clinical randomized trials are available in urology. Most significant articles are 4 prospective non-randomized match-case control. CONCLUSIONS: We are facing a Minilaparoscopy of second-generation with superior performance granted by new endoscopes and most effective instruments. Up to date, Minilaparoscopy has demonstrated in almost all urologic indication to be feasible, safe and able to improve cosmetic and postoperative pain control. Anyway, clinical randomized trials are still lacking and only studies from other discipline can corroborate this trend.

Laparoscopic radical prostatectomy: transfer validity.

OBJECTIVES: The impact of a formal fellowship training program on the independent practice of the trainees (i.e. transfer validity) has not been evaluated. We analyzed the transfer validity of a structured curriculum in an in-door as well as an out-door setting. METHODS: After completing their training, two fourth generation laparoscopic surgeons who started at the same time compared operative parameters and oncological outcomes in their independent practice, prospectively analyzing the next 100 patients in each. One surgeon continued laparoscopic radical prostatectomy (LRP) in the same center of excellence (Group-In), whereas the other implemented the procedure in a separate academic center (Group-Out). RESULTS: The demographics for both groups (Group-In vs Group-Out) were similar regarding age, prostate volume and preoperative prostate-specific antigen levels. Mean operation times (214.8 vs 224.2 min; P = 0.494) and estimated blood loss (472.4 vs 402.6 mL; P = 0.109) did not differ significantly in both groups as well as complication rate (20 vs 24%), median catheter time (8 vs 8.5 days) and continence rates at 12 months (95 vs 95.5%). According to the pathological stages, the rates of positive surgical margins were similar for pT2 (3.2 vs 4.3%) and pT3 (42.8 vs 45.2%), respectively. CONCLUSIONS: With a well designed, long-term preclinical and clinical fellowship training program, LRP techniques can be efficiently transferred from the center of excellence to other centers with no significant impact on surgical, functional and oncological outcomes.

Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention.

OBJECTIVES: To update the complications of transurethral resection of the prostate (TURP), including management and prevention based on technological evolution. METHODS: Based on a MEDLINE search from 1989 to 2005, the 2003 results of quality management of Baden-Württemberg, and long-term personal experience at three German centers, the incidence of complications after TURP was analyzed for three subsequent periods: early (1979-1994); intermediate (1994-1999); and recent (2000-2005) with recommendations for management and prevention. RESULTS: Technological improvements such as microprocessor-controlled units, better armamentarium such as video TUR, and training helped to reduce perioperative complications (recent vs. early) such as transfusion rate (0.4% vs. 7.1%), TUR syndrome (0.0% vs. 1.1%), clot retention (2% vs. 5%), and urinary tract infection (1.7% vs. 8.2%). Urinary retention (3% vs. 9%) is generally attributed to primary detrusor failure rather than to incomplete resection. Early urge incontinence occurs in up to 30-40% of patients; however, late iatrogenic stress incontinence is rare (<0.5%). Despite an increasing age (55% of patients are older than 70), the associated morbidity of TURP maintained at a low level (<1%) with a mortality rate of 0-0.25%. The major late complications are urethral strictures (2.2-9.8%) and bladder neck contractures (0.3-9.2%). The retreatment rate range is 3-14.5% after five years. CONCLUSIONS: TURP still represents the gold standard for managing benign prostatic hyperplasia with decreasing complication rates. Technological alternatives such as bipolar and laser treatments may further minimize the risks of this technically difficult procedure.

Laparoscopic and robotic assisted radical prostatectomy--critical analysis of the results.

OBJECTIVE: To evaluate the role of laparoscopic radical prostatectomy (LRP) and robotic assisted radical prostatectomy (RLRP) based on personal experience and a review of the literature. MATERIAL AND METHODS: Own experience at one European and one American LRP-center includes more than 2000 cases. We performed a MEDLINE search reviewing the literature on LRP and RLRP between 1992 and 2005 with special emphasis on historical aspects, technical considerations, comparison to open retropubic (RRP) and perineal radical prostatectomy (PRP), laparoscopic training, and the cost-efficiency of the techniques. RESULTS: Based on sophisticated training programs a continuous dissemination of the technique took place. In the United States, this process was accelerated by the use of the daVinci-robot. There is a trend towards the extraperitoneal access. Mid-term outcomes of LRP achieved equivalence to open surgery with regards to complications, oncologic and functional results. Distinct advantages of LRP include less postoperative pain, lower rate of complications, shorter convalescence, and better cosmesis. In contrast to RLRP, LRP may reach cost-equivalence with open surgery (i.e. by reduction of OR-time, use of multi-usable instruments). CONCLUSIONS: LRP reproduces the excellent results of open surgery providing the advantages of minimal access. Video-assisted teaching improves the transfer of anatomical knowledge and technical knowhow. In contrast the United States, the use of robots is likely to remain limited in Europe.

Laparoscopic versus open retroperitoneal lymph node dissection: a cost analysis.

PURPOSE: Laparoscopic retroperitoneal lymph node dissection is significantly less morbid than open retroperitoneal lymph node dissection but it is generally more costly due to longer operative time and disposable equipment. In response to budgetary pressure at our large county hospital we identified the cost components of laparoscopic retroperitoneal lymph node dissection that could be targeted to decrease procedure costs before expanding our laparoscopic retroperitoneal lymph node dissection program. MATERIALS AND METHODS: A comprehensive literature review of open and laparoscopic retroperitoneal lymph node dissection was performed and certain parameters were abstracted, including operative time and equipment, hospital stay, perioperative complications and surgical success rates. Using these data the projected overall cost and individual cost centers at our institution were compared for open and laparoscopic retroperitoneal lymph node dissection. Decision tree analysis models were devised to estimate the cost of each treatment using commercially available software. We performed 1 and 2-way sensitivity analysis to evaluate the effect of individual treatment variables on overall cost. Base case analysis involved a young man with clinical stage I nonseminomatous testicular cancer who was a candidate for retroperitoneal lymph node dissection. RESULTS: Based on a review of the costs at our institution open retroperitoneal lymph node dissection was a less costly procedure at $7,162 versus $7,804 for the laparoscopic approach. The slight cost superiority of the open approach was due to significantly lower costs associated with operating room time and equipment. On the other hand, the laparoscopic procedure showed a cost advantage for hospital stay. On 1-way sensitivity analysis laparoscopic dissection was less costly when operative time was less than 3.6 hours, hospitalization was less than 2.2 days or laparoscopic equipment costs were less than $768. On 2-way sensitivity analysis the laparoscopic approach was cost advantageous when performed in less than 5 hours or when the patient was discharged home within 2 days postoperatively. CONCLUSIONS: The primary cost variables for surgical treatment for testicular cancer include operative time, hospital stay and equipment cost. According to published data and decision tree analysis open retroperitoneal lymph node dissection is slightly less costly (less than $650) than laparoscopic retroperitoneal lymph node dissection for the surgical treatment of clinical stage I nonseminomatous testicular cancer at our institution. Our model identifies several measures that can be applied at any institution to render laparoscopic retroperitoneal lymph node dissection economically superior to the open approach.