David M. Albala

LOWER POLE I: A PROSPECTIVE RANDOMIZED TRIAL OF EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY AND PERCUTANEOUS NEPHROSTOLITHOTOMY FOR LOWER POLE NEPHROLITHIASIS—INITIAL RESULTS

PURPOSE The efficacy of shock wave lithotripsy and percutaneous stone removal for the treatment of symptomatic lower pole renal calculi was determined. MATERIALS AND METHODS A prospective randomized, multicenter clinical trial was performed comparing shock wave lithotripsy and percutaneous stone removal for symptomatic lower pole only renal calculi 30 mm. or less. RESULTS Of 128 patients enrolled in the study 60 with a mean stone size of 14.43 mm. were randomized to percutaneous stone removal (58 treated, 2 awaiting treatment) and 68 with a mean stone size of 14.03 mm. were randomized to shock wave lithotripsy (64 treated, 4 awaiting treatment). Followup at 3 months was available for 88% of treated patients. The 3-month postoperative stone-free rates overall were 95% for percutaneous removal versus 37% lithotripsy (p <0.001). Shock wave lithotripsy results varied inversely with stone burden while percutaneous stone-free rates were independent of stone burden. Stone clearance from the lower pole following shock wave lithotripsy was particularly problematic for calculi greater than 10 mm. in diameter with only 7 of 33 (21%) patients becoming stone-free. Re-treatment was necessary in 10 (16%) lithotripsy and 5 (9%) percutaneous cases. There were 9 treatment failures in the lithotripsy group and none in the percutaneous group. Ancillary treatment was necessary in 13% of lithotripsy and 2% percutaneous cases. Morbidity was low overall and did not differ significantly between the groups (percutaneous stone removal 22%, shock wave lithotripsy 11%, p =0.087). In the shock wave lithotripsy group there was no difference in lower pole anatomical measurements between kidneys in which complete stone clearance did or did not occur. CONCLUSIONS Stone clearance from the lower pole following shock wave lithotripsy is poor, especially for stones greater than 10 mm. in diameter. Calculi greater than 10 mm. in diameter are better managed initially with percutaneous removal due to its high degree of efficacy and acceptably low morbidity.

A retrospective comparison of anesthetic management of robot-assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy

STUDY OBJECTIVE To compare anesthetic management and postoperative outcomes in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP) and radical retropubic prostatectomy (RRP) with general anesthesia. DESIGN Retrospective database study of RALP and RRP patients at Duke University Medical Center from 6/2003 to 6/2006. SETTING University teaching hospital. PATIENTS 541 ASA physical status I, II, and III men, 280 of whom were RRP patients and 256 RALP patients. MEASUREMENTS Patient demographics, intraoperative fluids and blood products, hemodynamic parameters, pain scores in the Postanesthesia Care Unit (PACU), intraoperative and postoperative analgesic consumption, need for rescue antiemetics in the PACU, and intraoperative use of vasopressors and antihypertensives, were all recorded. Additional data included postoperative transfusion data; clinical status of the patients cancer preoperatively and postoperatively; hematocrit, platelet count, and creatinine levels; and length of hospital stay. MAIN RESULTS Estimated blood loss (EBL) was higher for RRP than RALP patients (mean +/- SD; 1,087 +/- 853 mL vs. 287 +/- 317 mL; P < 0.0001). Likewise, 24% of RRP patients received red blood cell (RBC) transfusions intraoperatively, compared with 0.4% RALP patients (P < 0.0001). Intraoperatively, RALP patients received more antihypertensive agents (37% vs. 21%; P < 0.0001), and fewer vasopressors (63% vs. 78%; P < 0.0001) than did RRP patients. The two groups had similar morphine-equivalent opioid use intraoperatively, but in the PACU, RALP patients required fewer morphine equivalents (mean +/- SD; 11.4 +/- 7.7 mg vs. 14.9 +/- 9.8 mg; P < 0.0001). The RALP patients had longer surgical times (mean +/- SD; 296 +/- 76 vs.193 +/- 69 min; P < 0.0001) but shorter PACU stays (mean +/- SD; 113 +/- 55 min vs. 143 +/- 58 min; P < 0.0001) and shorter hospital stays (mean +/- SD; 44 +/- 77 hrs vs. 56 +/- 26 hrs; P = 0.009). CONCLUSIONS Duration of surgery was greater with RALP, but it was associated with less EBL, fewer transfusions of blood products, and shorter PACU and hospital stays.

A comprehensive review of topical hemostatic agents: efficacy and recommendations for use.

Since ancient times we have attempted to facilitate hemostasis by application of topical agents. In the last decade, the number of different effective hemostatic agents has increased drastically. In order for the modern surgeon to successfully choose the right agent at the right time, it is essential to understand the mechanism of action, efficacy and possible adverse events as they relate to each agent. In this article we provide a comprehensive review of the most commonly used hemostatic agents, subcategorized as physical agents, absorbable agents, biologic agents, and synthetic agents. We also evaluate novel hemostatic dressings and their application in the current era. Furthermore, wholesale acquisition prices for hospitals in the United States are provided to aid in cost analysis. We conclude with an expert opinion on which agent to use under different scenarios.

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.

Transperitoneal nephrectomy for benign disease of the kidney: a comparison of laparoscopic and open surgical techniques.

OBJECTIVE The objective of this study was to compare the results of laparoscopic nephrectomy for benign disease to open surgical nephrectomy for benign disease. METHODS Twenty consecutive patients undergoing laparoscopic nephrectomy for benign disease were compared with 23 patients undergoing open surgical nephrectomy for benign disease and with 29 patients undergoing a donor nephrectomy. Data were collected in the following areas: patient age, anesthetic risk, operative time, estimated blood loss, postoperative time to resume oral intake, parenteral analgesics, oral analgesics, hospital stay, complications, and convalescence. Information was obtained through chart review, telephone interviews, and mailed questionnaires. RESULTS Compared with open surgical nephrectomy, laparoscopic nephrectomy resulted in a statistically significant longer operative time; however, it afforded a statistically significant decrease in postoperative ileus (open group), hospital stay (both groups), oral analgesics (donor group), and convalescence (both groups). The incidence of complications was 15 percent in the laparoscopic group and 0 percent in the two open surgical groups; the majority of complications occurred during the initial seven laparoscopic procedures. CONCLUSIONS Laparoscopic nephrectomy is a more time-consuming procedure than open surgical nephrectomy. Also, early in ones experience with this technique, the complication rate is higher than with open surgery. However, despite the newness of the technique, it results in significant benefits to the patient: decreased postoperative pain, shorter hospitalization, and more rapid convalescence.

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%.

Flaxseed Supplementation (Not Dietary Fat Restriction) Reduces Prostate Cancer Proliferation Rates in Men Presurgery

Background: Prostate cancer affects one of six men during their lifetime. Dietary factors are postulated to influence the development and progression of prostate cancer. Low-fat diets and flaxseed supplementation may offer potentially protective strategies. Methods: We undertook a multisite, randomized controlled trial to test the effects of low-fat and/or flaxseed-supplemented diets on the biology of the prostate and other biomarkers. Prostate cancer patients (n = 161) scheduled at least 21 days before prostatectomy were randomly assigned to one of the following arms: (a) control (usual diet), (b) flaxseed-supplemented diet (30 g/d), (c) low-fat diet (<20% total energy), or (d) flaxseed-supplemented, low-fat diet. Blood was drawn at baseline and before surgery and analyzed for prostate-specific antigen, sex hormone-binding globulin, testosterone, insulin-like growth factor-I and binding protein-3, C-reactive protein, and total and low-density lipoprotein cholesterol. Tumors were assessed for proliferation (Ki-67, the primary endpoint) and apoptosis. Results: Men were on protocol an average of 30 days. Proliferation rates were significantly lower (P < 0.002) among men assigned to the flaxseed arms. Median Ki-67-positive cells/total nuclei ratios (×100) were 1.66 (flaxseed-supplemented diet) and 1.50 (flaxseed-supplemented, low-fat diet) versus 3.23 (control) and 2.56 (low-fat diet). No differences were observed between arms with regard to side effects, apoptosis, and most serologic endpoints; however, men on low-fat diets experienced significant decreases in serum cholesterol (P = 0.048). Conclusions: Findings suggest that flaxseed is safe and associated with biological alterations that may be protective for prostate cancer. Data also further support low-fat diets to manage serum cholesterol. (Cancer Epidemiol Biomarkers Prev 2008;17(12):3577–87)

Optimal Therapy for the Distal Ureteral Stone: Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy

Extracorporeal shock wave lithotripsy (ESWL not equal to) is the optimal therapy for renal calculi less than 2 cm. in diameter and for proximal ureteral calculi. Controversy continues over the initial approach to distal ureteral calculi (that is below the bony pelvis): in situ ESWL versus ureteroscopy. Since February 1990, 76 distal ureteral calculi were treated at our institution using either in situ ESWL (Dornier HM3 ESWL with a Stryker frame modification in 27 patients or Siemens Lithostar electromagnetic ESWL in 22) or ureteroscopy (27 patients). Patient age and stone size were similar among the groups. All ESWL treatments were performed with the patient under intravenous sedation and on an outpatient basis. Stone-free rates were 96% for the HM3 device, 84% for the Lithostar and 100% for ureteroscopy. Retreatment was required in 3 Lithostar cases (14%) and 1 HM3 case (4%). When compared to ESWL ureteroscopy for distal ureteral stones was more time-consuming, entailed routine placement of a ureteral stent, often required general anesthesia, more often led to hospitalization and doubled the convalescence period. From a cost standpoint, ESWL on an HM3 unit was a few hundred dollars more expensive than ureteroscopy. In summary, we believe that in situ ESWL provides optimal first line therapy for distal ureteral calculi, while ureteroscopy is better reserved as a salvage procedure should ESWL fail.

A multicenter clinical trial investigating the use of a fluoroscopically controlled cutting balloon catheter for the management of ureteral and ureteropelvic junction obstruction

PURPOSE We assessed the efficacy of a fluoroscopically controlled cutting balloon catheter for the treatment of ureteropelvic junction and ureteral strictures. MATERIALS AND METHODS A multicenter trial was performed that included 66 endopyelotomies and 49 endoureterotomies. To our knowledge this study represents the largest number of patients with ureteropelvic junction obstruction and ureteral strictures tested with this device to date. RESULTS With a mean followup of 7.8 months (range 1 to 17.9) the patency rate was 77% for endopyelotomy, with 72% of the primary and 100% of the secondary ureteropelvic junction obstructions remaining patent. The endoureterotomy patients were followed for an average of 8.7 months (range 1.2 to 17.0), with a patency rate of 55%. CONCLUSIONS A cutting balloon endoscopic incision is effective in the majority of cases, with patency rates for endopyelotomies and endoureterotomies that mirror current endourological reports using other, albeit more time intensive and more invasive, incisional techniques.

Assessment of stricture formation with the ureteral access sheath

OBJECTIVES To analyze the long-term incidence of ureteral stricture formation in a series of patients in whom a new-generation ureteral access sheath was used. A new generation of ureteral access sheaths has been developed to facilitate ureteroscopic procedures. However, some have questioned their safety and whether the device might cause significant ureteral trauma. METHODS Between September 1999 and July 2001, 150 consecutive ureteroscopic procedures with adjunctive use of an access sheath were performed. A retrospective chart review to April 2002 was done. Of the 150 patients, 130 underwent ureteroscopy for ureteral stones. Patients who underwent endoureterotomy or treatment of transitional cell carcinoma were excluded from this analysis. Sixty-two patients had follow-up greater than 3 months and were included in the analysis. Overall, 71 ureteroscopic procedures were performed, with 9 patients undergoing multiple procedures. Ninety-two percent of the patients had pathologic findings above the iliac vessels. The average patient age was 45.3 years (range 17 to 76), and 70% and 30% of the patients were male and female, respectively. The mean clinical follow-up was 332 days (range 95 to 821), and follow-up imaging was performed within 3 months after ureteroscopy in all patients. RESULTS The 10/12F access sheath was used in 8 ureteroscopic procedures (11.2%), the 12/14F access sheath in 56 (78.9%), and the 14/16F access sheath in 7 (9.8%). One stricture was identified on follow-up imaging of 71 procedures performed, for an incidence of 1.4%. The patient developed the stricture at the ureteropelvic junction after multiple ureteroscopic procedures to manage recurrent struvite calculi. The access sheath did not appear to be a contributing factor. CONCLUSIONS The results of our series indicate that the ureteral access sheath is safe and beneficial for routine use to facilitate flexible ureteroscopy. However, awareness of the potential ischemic effects with the use of unnecessarily large sheaths for long periods in patients at risk of ischemic injury should be considered. We advocate the routine use of the device for most flexible ureteroscopic procedures proximal to the iliac vessels.