Raju Thomas

Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons.

PURPOSE With the exponential growth of robotic urological surgery, particularly with robot assisted radical prostatectomy, guidelines for safe initiation of this technology are a necessity. Currently no standardized credentialing system exists to our knowledge to evaluate surgeon competency and safety with robotic urological surgery performance. Although proctoring is a modality by which such competency can be evaluated, other training tools and guidelines are needed to ensure that the requisite knowledge and technical skills to perform this procedure have been acquired. We evaluated the current status of proctoring and credentialing in other surgical specialties to discuss and recommend its application and implementation specifically for robot assisted radical prostatectomy. MATERIALS AND METHODS We reviewed the literature on safety and medicolegal implications of proctoring and the safe introduction of surgical procedures to develop recommendations for robot assisted radical prostatectomy proctoring and credentialing. RESULTS Proctoring is an essential mechanism for robot assisted radical prostatectomy institutional credentialing and should be a prerequisite for granting unrestricted privileges on the robot. This should be differentiated from preceptoring, wherein the expert is directly involved in hands-on training. Advanced technology has opened new avenues for long-distance observation through teleproctoring. Although the medicolegal implications of an active surgical intervention by a proctor are not clearly defined, the role as an observer should grant immunity from malpractice liability. CONCLUSIONS The implementation of guidelines and proctoring recommendations is necessary to protect surgeons, proctors, institutions and, above all, the patients who are associated with the institutional introduction of a robot assisted radical prostatectomy program. With no current guidelines we anticipate this article will serve as a catalyst of interorganizational discussion to initiate regulatory oversight of surgeon certification and proctorship.

OPEN DONOR, LAPAROSCOPIC DONOR AND HAND ASSISTED LAPAROSCOPIC DONOR NEPHRECTOMY: A COMPARISON OF OUTCOMES

PURPOSE In experienced hands laparoscopic surgery has been shown to be safe for procuring kidneys for transplantation that function identically to open nephrectomy controls. While searching for a safer and easier approach to laparoscopic donor nephrectomy, hand assisted laparoscopic techniques have been added to the surgical armamentarium. We compare allograft function in patients with greater than 1-year followup who underwent open donor (historic series), classic laparoscopic and hand assisted laparoscopic nephrectomy. MATERIALS AND METHODS The charts of 48 patients who underwent open donor, laparoscopic donor or hand assisted laparoscopic nephrectomy were reviewed. Only patients with greater than 1-year followup and complete charts were included in our study. Of these patients 34 underwent consecutive laparoscopic live donor nephrectomy and 14 underwent open donor nephrectomy. Mean patient age plus or minus standard deviation (SD) was 36.5 +/- 8.4 years for donors and 29 +/- 17 for recipients at transplantation (range 13 months to 69 years). In the laparoscopic group 11 patients underwent the transperitoneal technique, and 23 underwent hand assisted laparoscopic nephrectomy. RESULTS Total operating time was significantly reduced with the hand assisted laparoscopic technique compared with classic laparoscopy, as was the time from skin incision to kidney removal and warm ischemic time. Average warm ischemic time plus or minus SD was 3.9 +/- 0.3 minutes for laparoscopic nephrectomy and 1.6 +/- 0.2 for hand assisted laparoscopy (p <0.05). Long-term followup of serum creatinine levels revealed no significant differences among the 3 groups. Comparison of those levels for recipients of open nephrectomy versus laparoscopic and hand assisted laparoscopic techniques revealed p values greater than 0.5. No blood transfusions were necessary. Complications included adrenal vein injury in 1 patient, small bowel obstruction in 2, abdominal hernia at the trocar site in 1 and deep venous thrombosis in 1. CONCLUSIONS Classic laparoscopic donor and hand assisted laparoscopic donor nephrectomies appear to be safe procedures for harvesting kidneys. The recipient graft function is similar in the laparoscopic and open surgery groups.

Laparoscopic living donor nephrectomy: advantages of the hand-assisted method.

INTRODUCTION The laparoscopic technique for living donor nephrectomy is a technically difficult procedure that has not yet gained widespread acceptance in the transplant community. The procedure may be more acceptable if alterations to the technique made it easier to perform and decreased operative times. METHODS In August 1998, we altered the laparoscopic procedure to include the use of a device allowing hand assistance. Subsequently, all living donor nephrectomies have been done using the hand-assisted method. In this article, the results of 10 cases performed using the original laparoscopic technique are compared with the results of 12 cases using the hand-assisted technique, and a brief description of modifications to the original technique is given. RESULTS No patients where turned down as living donors, and no contraindications to the pure or hand-assisted laparoscopic techniques where found. The hand-assisted technique significantly reduced the operative time (2.02+/-0.44 vs. 3.12+/-0.36 hr, P<0.05) and the warm ischemic time (1.23+/-0.54 vs. 3.91+/-0.53 min, P<0.05). The length of stay and recovery time to normal activities were not different between the pure laparoscopic and hand-assisted groups. CONCLUSION The advantages of the hand-assisted technique include the ability to use tactile sense to facilitate dissection, retraction, and exposure. In addition, the final stages of vascular stapling and kidney removal are more sure and rapid. The modifications of the laparoscopic technique presented here provide measurable and subjective improvements to laparoscopic living donor nephrectomy. The hand-assisted method of laparoscopic nephrectomy may make the operation available to more transplant centers.

Retroperitoneal and pelvic extraperitoneal laparoscopy : An international perspective

OBJECTIVES To assess technical preferences and current practice trends of retroperitoneal and pelvic extraperitoneal laparoscopy. METHODS A questionnaire survey of 36 selected urologic laparoscopic centers worldwide was performed. RESULTS Twenty-four centers (67%) responded. Overall, 3988 laparoscopic procedures were reported: transperitoneal approach (n = 2945) and retroperitoneal/extraperitoneal approach (n = 1043). Retroperitoneoscopic/extraperitoneoscopic procedures included adrenalectomy (n = 74), nephrectomy (n = 299), ureteral procedures (n = 166), pelvic lymph node dissection (n = 197), bladder neck suspension (n = 210), varix ligation (n = 91), and lumbar sympathectomy (n = 6). Mean number of total laparoscopic procedures performed in 1995 per center was 41 (range 5 to 86). Major complications occurred in 49 (4.7%) patients and included visceral complications in 26 (2.5%) patients and vascular complications in 23 (2.2%). Open conversion was performed in 69 (6.6%) patients, electively in 41 and emergently in 28 (visceral injuries, n = 16; vascular injuries, n = 1 2). Retroperitoneoscopy/extraperitoneoscopy is gaining in acceptance worldwide: in 1993, the mean estimated ratio of transperitoneal laparoscopic cases versus retroperitoneoscopic/ extraperitoneoscopic cases per center was 74:26; however, in 1996 the ratio was 49:51. CONCLUSIONS Retroperitoneoscopy and pelvic extraperitoneoscopy are important adjuncts to the laparoscopic armamentarium in urologic surgery. The overall major complication rate associated with retroperitoneoscopy/extraperitoneoscopy was 4.7%.

The Learning Curve of Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium

BACKGROUND Robot-assisted radical cystectomy (RARC) has evolved as a minimally invasive alternative to open radical cystectomy for patients with invasive bladder cancer. OBJECTIVE We sought to define the learning curve for RARC by evaluating results from a multicenter, contemporary, consecutive series of patients who underwent this procedure. DESIGN, SETTING, AND PARTICIPANTS Utilizing the International Robotic Cystectomy Consortium database, a prospectively maintained and institutional review board-approved database, we identified 496 patients who underwent RARC by 21 surgeons at 14 institutions from 2003 to 2009. MEASUREMENTS Cut-off points for operative time, lymph node yield (LNY), estimated blood loss (EBL), and margin positivity were identified. Using specifically designed statistical mixed models, we were able to inversely predict the number of patients required for an institution to reach the predetermined cut-off points. RESULTS AND LIMITATIONS Mean operative time was 386 min, mean EBL was 408 ml, and mean LNY was 18. Overall, 34 of 482 patients (7%) had a positive surgical margin (PSM). Using statistical models, it was estimated that 21 patients were required for operative time to reach 6.5h and 8, 20, and 30 patients were required to reach an LNY of 12, 16, and 20, respectively. For all patients, PSM rates of <5% were achieved after 30 patients. For patients with pathologic stage higher than T2, PSM rates of <15% were achieved after 24 patients. CONCLUSIONS RARC is a challenging procedure but is a technique that is reproducible throughout multiple centers. This report helps to define the learning curve for RARC and demonstrates an acceptable level of proficiency by the 30th case for proxy measures of RARC quality.

THE FORGOTTEN INDWELLING URETERAL STENT: A UROLOGICAL DILEMMA

Ureteral stents are an integral part of urological practice. However, stents that migrate, fragment or are forgotten pose a management and legal dilemma. Our series consists of 31 patients, 22 with forgotten stents that were left indwelling for more than 6 months (mean 22.7) and 9 migrated stents. Of the forgotten stents 15 (68%) were calcified, 10 (45%) were fragmented, and 3 (14%) were calcified and fragmented. Procedures to render the patient stent-free were ureteroscopy in 16 (52%), percutaneous nephroscopy in 8 (26%), cystoscopic electrohydraulic lithotripsy in 6 (19%), extracorporeal shock wave lithotripsy in 10 (32%), open cysto-litholapaxy in 1 (3%) and simple nephrectomy in 1 (3%). Multiple procedures were required in 6 patients (19%). Management of such complicated ureteral stents requires a multimodal therapeutic approach incorporating the latest in extracorporeal shock wave lithotripsy and endourological techniques. These patients are at increased risk for loss of renal function. A computerized tracking registry of ureteral stents may help prevent this urological travesty.

Surgical Margin Status After Robot Assisted Radical Cystectomy: Results From the International Robotic Cystectomy Consortium

PURPOSE Positive surgical margins at radical cystectomy confer a poor prognosis. We evaluated the incidence and predictors of positive surgical margins in patients who underwent robot assisted radical cystectomy for bladder cancer. MATERIALS AND METHODS Using the International Robotic Cystectomy Consortium database we identified 513 patients who underwent robot assisted radical cystectomy, as done by a total of 22 surgeons at 15 institutions from 2003 to 2009. After stratification by age group, gender, pathological T stage, nodal status, sequential case number and institutional volume logistic regression was used to correlate variables with the likelihood of a positive surgical margin. RESULTS Of the 513 patients 35 (6.8%) had a positive surgical margin. Increasing 10-year age group, lymph node positivity and higher pathological T stage were significantly associated with an increased likelihood of a positive margin (p = 0.010, <0.001 and p <0.001, respectively). Gender, sequential case number and institutional volume were not significantly associated with margin positivity. The rate of margin positive disease at cystectomy was 1.5% for pT2 or less, 8.8% for pT3 and 39% for pT4 disease. CONCLUSIONS Positive surgical margin rates at robot assisted radical cystectomy for advanced bladder cancer were similar to those in open cystectomy series in a large, multi-institutional, prospective cohort. Sequential case number, a surrogate for the learning curve and institutional volume were not significantly associated with positive margins at robot assisted radical cystectomy.

Neoplastic Reprogramming of Patient-Derived Adipose Stem Cells by Prostate Cancer Cell-Associated Exosomes

Emerging evidence suggests that mesenchymal stem cells (MSCs) are often recruited to tumor sites but their functional significance in tumor growth and disease progression remains elusive. Herein we report that prostate cancer (PC) cell microenvironment subverts PC patient adipose‐derived stem cells (pASCs) to undergo neoplastic transformation. Unlike normal ASCs, the pASCs primed with PC cell conditioned media (CM) formed prostate‐like neoplastic lesions in vivo and reproduced aggressive tumors in secondary recipients. The pASC tumors acquired cytogenetic aberrations and mesenchymal‐to‐epithelial transition and expressed epithelial, neoplastic, and vasculogenic markers reminiscent of molecular features of PC tumor xenografts. Our mechanistic studies revealed that PC cell‐derived exosomes are sufficient to recapitulate formation of prostate tumorigenic mimicry generated by CM‐primed pASCs in vivo. In addition to downregulation of the large tumor suppressor homolog2 and the programmed cell death protein 4, a neoplastic transformation inhibitor, the tumorigenic reprogramming of pASCs was associated with trafficking by PC cell‐derived exosomes of oncogenic factors, including H‐ras and K‐ras transcripts, oncomiRNAs miR‐125b, miR‐130b, and miR‐155 as well as the Ras superfamily of GTPases Rab1a, Rab1b, and Rab11a. Our findings implicate a new role for PC cell‐derived exosomes in clonal expansion of tumors through neoplastic reprogramming of tumor tropic ASCs in cancer patients. Stem Cells 2014;32:983–997

Improved detection of renal pathologic features on multiphasic helical CT compared with IVU in patients presenting with microscopic hematuria.

OBJECTIVES To examine the virtues of multiphasic helical computed tomography (CT) in the diagnosis of upper urinary tract lesions refractory to identification by intravenous urography (IVU). METHODS A total of 86 patients (59 men and 27 women), 27 to 88 years old, with microscopic hematuria and negative IVU findings were examined with multiphasic helical CT consisting of a pre-enhancement, late arterial-early cortical-medullary, nephrographic, and excretory phase helical CT of the kidneys, using 3 to 5-mm collimation and 7.5-mm/s table feed. RESULTS The multiphasic helical CT was conclusive in 84 lesions. Twenty-five cases of early papillary and medullary necrosis, 7 of 8 inflammatory lesions, 3 caliceal diverticula, 1 lupus nephritis, 26 small calculi, 2 medullary sponge kidney, 5 vascular anomalies, and 3 infarcts presented with characteristic manifestations on CT but lacked findings on IVU. Similarly 8 of 9 small malignant neoplasms, 2 small benign neoplasms, and 2 small cysts produced no detectable findings on IVU but were readily diagnosed on helical CT. CONCLUSIONS Characteristic findings, particularly on late arterial, early corticomedullary, parenchymal, and excretory phase helical CT make possible the diagnosis of early inflammatory disease, small masses and neoplastic lesions, and vascular abnormalities. Limited resolution (needed to identify small calculi) and the lack of ability to capture phases significantly reduce the diagnostic ability of IVU.

Multi-Institutional Analysis of Robotic Radical Cystectomy for Bladder Cancer: Perioperative Outcomes and Complications in 227 Patients

PURPOSE Recently, some surgeons have begun to describe single-institution case series with less invasive surgical approaches to bladder cancer such as laparoscopic or robotic-assisted techniques. We report on a multi-institutional, multi-surgeon experience with robotic radical cystectomy with regard to operative and pathologic outcomes and complications to evaluate the feasibility and reproducibility of this technique in a large cohort of patients. SUBJECTS AND METHODS Two hundred twenty-seven patients (178 males and 49 females) underwent a robotic cystectomy and urinary diversion at one of four institutions. Operative outcomes, pathological results, and complications of this combined case series are herein reported. RESULTS Mean age of this cohort was 67.1 years (range, 33-86 years) with a mean American Society of Anesthesiologists score of 2.7 (range, 2-4). One hundred sixty-eight patients (74%) underwent ileal conduit diversion, 58 (26%) underwent orthotopic ileal neobladder, and 1 patient (<1%) had no diversion (end-stage renal disease). The urinary diversion was performed extracorporeally in 97% cases, with 7 patients (3%) undergoing an intracorporeal diversion. Mean operating room time of all patients was 5.5 hours, and mean surgical blood loss was 256 mL. On surgical pathology, 120 (53%) patients had pT2 or less disease, 35 (15%) had pT3/T4 disease, and 46 (20%) had N+ disease. The mean number of lymph nodes removed was 18 (range, 3-52). There was a positive surgical margin in 5 cases--all with pT3-4 disease. Mean time to discharge was 5.5 days (median, 5 days), with 70% of patients discharged on postoperative day 5 or sooner. Sixty-eight patients (30%) experienced complications, with 7% having Clavien grade 3 or higher. On multivariate analysis, decreased age and increased American Society of Anesthesiologists score were predictors of higher Clavien complication score, with younger patients more likely to undergo neoadjuvant chemotherapy prior to surgery. CONCLUSION A multi-institutional experience with robotic radical cystectomy appears to demonstrate acceptable operative and pathologic outcomes, thus helping to validate the previously reported single-institution case series. Ultimately, oncologic follow-up of these patients will remain as the most important measure of therapeutic success.