Riccardo Autorino

Laparoendoscopic Single-site Surgery in Urology: Worldwide Multi-institutional Analysis of 1076 Cases

BACKGROUND Laparoendoscopic single-site surgery (LESS) has gained popularity in urology over the last few years. OBJECTIVE To report a large multi-institutional worldwide series of LESS in urology. DESIGN, SETTING, AND PARTICIPANTS Consecutive cases of LESS done between August 2007 and November 2010 at 18 participating institutions were included in this retrospective analysis. INTERVENTION Each group performed a variety of LESS procedures according to its own protocols, entry criteria, and techniques. MEASUREMENTS Demographic data, main perioperative outcome parameters, and information related to the surgical technique were gathered and analyzed. Conversions to reduced-port laparoscopy, conventional laparoscopy, or open surgery were evaluated, as were intraoperative and postoperative complications. RESULTS AND LIMITATIONS Overall, 1076 patients were included in the analysis. The most common procedures were extirpative or ablative operations in the upper urinary tract. The da Vinci robot was used to operate on 143 patients (13%). A single-port technique was most commonly used and the umbilicus represented the most common access site. Overall, operative time was 160±93 min and estimated blood loss was 148±234 ml. Skin incision length at closure was 3.5±1.5 cm. Mean hospital stay was 3.6±2.7 d with a visual analog pain score at discharge of 1.5±1.4. An additional port was used in 23% of cases. The overall conversion rate was 20.8%; 15.8% of patients were converted to reduced-port laparoscopy, 4% to conventional laparoscopy/robotic surgery, and 1% to open surgery. The intraoperative complication rate was 3.3%. Postoperative complications, mostly low grade, were encountered in 9.5% of cases. CONCLUSIONS This study provides a global view of the evolution of LESS in the field of minimally invasive urologic surgery. A broad range of procedures have been effectively performed, primarily in the academic setting, within diverse health care systems around the world. Since LESS is performed by experienced laparoscopic surgeons, the risk of complications remains low when stringent patient-selection criteria are applied.

Laparoendoscopic Single-site and Natural Orifice Transluminal Endoscopic Surgery in Urology: A Critical Analysis of the Literature ☆

CONTEXT Natural orifice transluminal endoscopic surgery (NOTES) and laparoendoscopic single-site surgery (LESS) have been developed to benefit patients by enabling surgeons to perform scarless surgery. OBJECTIVE To summarize and critically analyze the available evidence on the current status and future perspectives of LESS and NOTES in urology. EVIDENCE ACQUISITION A comprehensive electronic literature search was conducted in June 2010 using the Medline database to identify all publications relating to NOTES and LESS in urology. EVIDENCE SYNTHESIS In urology, NOTES has been completed experimentally via transgastric, transvaginal, transcolonic, and transvesical routes. Initial clinical experience has shown that NOTES urologic surgery using currently available instruments is indeed possible. Nevertheless, because of the immaturity of the instrumentation, early cases have demanded high technical virtuosity. LESS can safely and effectively be performed in a variety of urologic settings. As clinical experience increases, expanding indications are expected to be documented and the efficacy of the procedure to improve. So far, the quality of evidence of all available studies remains low, mostly being small case series or case-control studies from selected centers. Thus, the only objective benefit of LESS remains the improved cosmetic outcome. Prospective, randomized studies are largely awaited to determine which LESS procedures will be established and which are unlikely to stand the test of time. Technology advances hold promise to minimize the challenging technical nature of scarless surgery. In this respect, robotics is likely to drive a major paradigm shift in the development of LESS and NOTES. CONCLUSIONS NOTES is still an investigational approach in urology. LESS has proven to be immediately applicable in the clinical field, being safe and feasible in the hands of experienced laparoscopic surgeons. Development of instrumentation and application of robotic technology are expected to define the actual role of these techniques in minimally invasive urologic surgery.

Novel Robotic da Vinci Instruments for Laparoendoscopic Single-site Surgery

OBJECTIVES To describe novel robotic laparoendoscopic single-site surgery (R-LESS) instruments, and present the initial laboratory experience in urology. METHODS The VeSPA surgical instruments (Intuitive Surgical, Sunnyvale, CA) were designed to be used with the DaVinci Si surgical system. A multichannel port and curved cannulae were inserted through a single 3.5-cm umbilical incision. The port allowed 1 scope, 2 robotic instruments, and a 5- to 12-mm assistant instrument. Four pyeloplasties (right 2, left 2), 4 partial nephrectomies (right 2, left 2), and 8 nephrectomies (right 4, left 4) were performed in 4 female farm pigs (mean weight, 34.5 kg). Technical feasibility and efficiency were assessed in addition to perioperative outcomes. RESULTS All 16 R-LESS procedures were performed successfully without the addition of laparoscopic ports or open conversion. Mean total operative time was 110 minutes (range, 82-127), and mean blood loss was 20 mL (range, 10-100). Mean warm ischemia time for partial nephrectomy was 14.8 minutes (range, 12-20). There were no intraoperative complications. No robotic system failures occurred, and robotic instrument clashing was found to be minimal. One needle driver malfunctioned and assistant movement was limited. CONCLUSIONS R-LESS kidney surgery using the VeSPA instruments is feasible and efficient in the porcine model. The system offers a wide range of motion, instrument and scope stability, improved ergonomics, and minimal instrument clashing. Although preliminary experience is encouraging, further refinements are expected to optimize urological applications of this robotic technology.

Early and Late Complications of Double Pigtail Ureteral Stent

Objectives: To analyze the early and late complications of indwelling ureteral stents in a series of 146 patients with nephroureteral lithiasis. Materials and Methods: 146 patients with obstructing nephrolitiasis were treated for urinary diversion with double pigtail ureteral stent before extracorporeal shock-wave lithotripsy (ESWL) and following ureterorenoscopic treatment of lithiasis. All patients were scheduled for stent removal or replacement at specific 3-month intervals until stone-free status was achieved. Results: Early complications during the first 4 weeks after stent insertion were stent discomfort (37.6%), irritative bladder symptoms (18.8%), hematuria (18.1%), bacteriuria (15.2%), fever >104F (12.3%) and flank pain (25.3%); late complications included hydronephrosis (5.7%), and stent migration (9.5%), encrustation (21.6%), fragmentation (1.9%) and breakage (1.3%). Conclusions: Ureteral stents have proven to be an invaluable tool for endourologists. Morbidity is minimal for up to three months but longer indwelling times are associated with an increasing frequency of incrustation, infections, secondary stone formation and obstruction of the stented tract.

Modified Supine versus Prone Position in Percutaneous Nephrolithotomy for Renal Stones Treatable with a Single Percutaneous Access: A Prospective Randomized Trial

OBJECTIVES To compare operative time, safety, and effectiveness of percutaneous nephrolithotomy in the supine versus prone position in a prospective randomized trial. MATERIAL AND METHODS From October 2005 to June 2007, 75 patients (33 men, 42 women; mean age, 39.3 yr) were prospectively enrolled and randomly divided into group A (39 patients, supine position) and group B (36 patients, prone position). Inclusion criteria were diagnosis of single or multiple renal stones (pelvic-caliceal) treatable with a single percutaneous access, stone diameter >2.5cm, body mass index (BMI) <30kg/m(2), and no contraindications to perform the operation in the prone position. Exclusion criteria were stones in more than one calyx, complete staghorn stones, and coexisting renal anomalies. RESULTS The two groups were comparable in age, BMI, male-to-female ratio, and stone size. No significant difference was ascertained between the two groups in terms of stone-free rate (group A, 88.7% vs. group B, 91.6%, p=0.12), mean blood loss (group A, Delta hemoglobin -2.3g/dl vs. group B, -2.2g/dl, p=0.23), and mean hospital stay (group A, 4.3 d vs. group B, 4.1 d, p=0.18). The only significant difference reported was mean operative time (group A, 43min vs. group B, 68min, p<0.001). No blood transfusions were needed and no organ injuries were reported. CONCLUSIONS In this carefully selected patient population with uncomplicated renal stones, the supine position was similar to the prone position for percutaneous stone removal.

Robotic Versus Laparoscopic Partial Nephrectomy: Single-surgeon Matched Cohort Study of 150 Patients

OBJECTIVES To present comparative outcomes among matched patients who underwent robotic partial nephrectomy (RPN) or laparoscopic partial nephrectomy (LPN) by a single surgeon at a single institution. METHODS Between March 2002 and August 2009, a retrospective review of 261 consecutive patients who underwent LPN (n = 186) or RPN (n = 75) by a single surgeon was performed. Patients were matched for age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) score, and tumor size, side, and location. Perioperative outcomes were compared. RESULTS A matched cohort of 150 patients who underwent RPN (n = 75) or LPN (n = 75) were compared. There was no significant difference between the 2 cohorts with respect to patient age (P = .17), BMI (P = .68), ASA score (P = .96), preoperative estimated glomerulofiltration rate (eGFR; P = .54), or tumor size (P = .17). Mean operative time for RPN was 200 vs 197 minutes for LPN (P = .75). Mean estimated blood loss (EBL) was higher in the RPN cohort (323 vs 222 mL, P = .01). There was no significant difference with respect to warm ischemia time (18.2 minutes vs 20.3 minutes, P = .27), length of hospitalization (P = .84), percent change in eGFR (P = .80), or adverse events (P = .52). All surgical margins were negative. CONCLUSIONS Although initial surgical experience with RPN was included in this study and compared with a vast experience in LPN by the same surgeon, RPN offers at least comparable outcomes to LPN.

Comparative Outcomes and Assessment of Trifecta in 500 Robotic and Laparoscopic Partial Nephrectomy Cases: A Single Surgeon Experience

PURPOSE We report a comparative analysis of a large series of laparoscopic and robotic partial nephrectomies performed by a high volume single surgeon at a tertiary care institution. MATERIALS AND METHODS We retrospectively reviewed the medical charts of 500 patients treated with minimally invasive partial nephrectomy by a single surgeon between March 2002 and February 2012. Demographic and perioperative data were collected and statistically analyzed. R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to the collecting system or sinus in mm, anterior/posterior and location relative to polar lines) nephrometry score was used to score tumors. Those scored as moderate and high complexity were designated as complex. Trifecta was defined as a combination of warm ischemia time less than 25 minutes, negative surgical margins and no perioperative complications. RESULTS Two groups were identified, including 261 patients with robotic and 231 with laparoscopic partial nephrectomy. Demographics were similar in the groups. The robotic group was significantly more morbid (Charlson comorbidity index 3.75 vs 1.26), included more complex tumors (R.E.N.A.L. score 5.98 vs 7.2), and had lower operative (169.9 vs 191.7 minutes) and warm ischemia (17.9 vs 25.2 minutes) time, intraoperative (2.6% vs 5.6%, each p <0.001) and postoperative (24.53% vs 32.03%, p = 0.004) complications, and positive margin rate (2.9% vs 5.6%, p <0.001). Thus, a higher overall trifecta rate was observed for robotic partial nephrectomy (58.7% vs 31.6%, p <0.001). The laparoscopic group had longer followup (3.43 vs 1.51 years, p <0.001) and no significant difference in postoperative changes in renal function. Main study limitations were the retrospective nature, arbitrary definition of trifecta and shorter followup in the RPN group. CONCLUSIONS Our large comparative analysis shows that robotic partial nephrectomy offers a wider range of indications, better operative outcomes and lower perioperative morbidity than laparoscopic partial nephrectomy. Overall, the quest for trifecta seems to be better accomplished by robotic partial nephrectomy, which is likely to become the new standard for minimally invasive partial nephrectomy.

Combination of Bevacizumab and Docetaxel in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer: A Phase 2 Study

OBJECTIVE Although the taxanes represent the most active agents for the first-line treatment of metastatic hormone-refractory prostate cancer (HRPC), most patients eventually progress while receiving taxane-based treatments. No agents are approved for second-line therapy in HRPC, but common standard practice for the oncologists is to treat patients also after docetaxel failure. METHODS Twenty highly pretreated patients with HRPC received bevacizumab (10mg/kg) and docetaxel (60mg/m(2)) every 3 wk. All patients had bone metastases and eight had measurable lesions. RESULTS Eleven patients (55%) had major prostate-specific antigen (PSA) responses, and 3 (37.5%) had objective responses. Seven major PSA responses were recorded in the same patients who had reported a >50% PSA decrease after first-line docetaxel. However, four major PSA responses were observed in patients previously nonresponsive to docetaxel alone. The treatment was well tolerated. CONCLUSIONS Our results show that the combination of bevacizumab and docetaxel is active and well tolerated. Continued investigation of bevacizumab with cytotoxic chemotherapy is warranted in HRPC.

Phase II Study of Sorafenib in Patients With Sunitinib-Refractory Metastatic Renal Cell Cancer

PURPOSE No previous prospective trials have been reported with sorafenib in patients with sunitinib-refractory metastatic renal cell cancer (MRCC). We conducted a multicenter study to determine the activity and tolerability of sorafenib as second-line therapy after sunitinib progression in MRCC. PATIENTS AND METHODS Between January 2006 and September 2008, 52 patients were enrolled onto this single-arm phase II study. All patients received sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity. The primary end point was objective response rate (complete or partial response) evaluated every 8 weeks by use of the Response Evaluation Criteria in Solid Tumors; secondary end points were toxicity, time to progression (TTP), and overall survival (OS). RESULTS All patients were included in response and safety analyses. Partial responses were observed in 9.6% of patients (five of 52 patients; 95% CI, 5% to 17%) after two cycles. Grade 1 to 2 fatigue, diarrhea, nausea/vomiting, rash, and neutropenia were the most common side effects, noted in 16 (30.8%), 19 (36.5%), 20 (38.5%), 19 (36.5%), and 20 patients (38.5%), respectively. The most common grade 3 toxicity was diarrhea, noted in six patients (11.5%). Median TTP was 16 weeks (range, 8 to 40 weeks), and median OS was 32 weeks (range, 16 to 64 weeks). CONCLUSION Although well tolerated, sorafenib shows limited efficacy in sunitinib-refractory MRCC. Further randomized trials comparing sorafenib with other drugs that target different biologic pathways are needed to define the best second-line treatment option in these patients.

Robotic Versus Laparoscopic Partial Nephrectomy for Complex Tumors: Comparison of Perioperative Outcomes

BACKGROUND Recent studies showed that robotic partial nephrectomy (RPN) offered outcomes at least comparable to those of laparoscopic partial nephrectomy (LPN). LPN can be particularly challenging for more complex tumors. OBJECTIVE To compare the perioperative outcomes of patients undergoing LPN or RPN for a single renal mass of moderate or high complexity. DESIGN, SETTING, AND PARTICIPANTS A retrospective analysis was performed for 381 consecutive patients who underwent either LPN (n = 182) or RPN (n = 199) between 2005 and 2011 for a complex renal mass (RENAL score ≥ 7). Perioperative outcomes were compared. Predictors of postoperative renal function were assessed using multivariable linear regression analysis. INTERVENTION LPN or RPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Perioperative outcomes were compared. Predictors of postoperative renal function were assessed using multivariable linear regression analysis. RESULTS AND LIMITATIONS There was no significant difference between the two groups with respect to patient age, gender, side, American Society of Anesthesiologists score, Charlson comorbidity index (CCI), or tumor size. Patients undergoing LPN had a slightly lower body mass index (29.2 kg/m(2) compared with 30.7 kg/m(2), p = 0.02) and preoperative estimated glomerular filtration rate (eGFR) (81.1 compared with 86.0 ml/min per 1.73 m(2), p = 0.02). LPN was associated with an increased rate of conversion to radical nephrectomy (RN) (11.5% compared with 1%, p<0.001) and a higher decrease in percentage of eGFR (-16.0% compared with -12.6%, p = 0.03). There were no significant differences with respect to warm ischemia time (WIT), estimated blood loss, transfusion rate, or postoperative complications. WIT, preoperative eGFR, and CCI were found to be predictors of postoperative eGFR in multivariable analysis. No difference in perioperative outcomes was found between moderate and high RENAL score subgroups. The retrospective study design was the main limitation of this study. CONCLUSIONS RPN provides functional outcomes comparable to those of LPN for moderate- to high-complexity tumors, but with a significantly lower risk of conversion to RN. This situation is likely because of the technical advantages offered by the articulated robotic instruments. A prospective randomized study is needed to confirm these findings.