Kevin C. Zorn

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.

A Critical Analysis of the Long-Term Impact of Radical Prostatectomy on Cancer Control and Function Outcomes

CONTEXT The optimal management strategy for men with newly diagnosed clinically localized prostate cancer remains a matter of debate. Numerous series have reported cancer control and quality-of-life (QoL) outcomes following treatment with radical prostatectomy (RP). OBJECTIVE Critically review published oncologic and functional outcomes after RP, and evaluate factors associated with these outcome measures. EVIDENCE ACQUISITION A review of the literature was performed using the Medline and Web of Sciences databases. Relevant reports published between 1980 and 2011 identified using the keywords prostate cancer, radical prostatectomy, prostate-specific antigen, biochemical recurrence, incontinence, and erectile dysfunction were reviewed and summarized. EVIDENCE SYNTHESIS Cancer control rates following RP largely depend on the definition of treatment efficacy. While up to 40% of men have been reported to experience postoperative biochemical recurrence on long-term follow-up, death from prostate cancer has been noted in <10% of men at 15 yr after surgery in contemporary series. For men with high-risk disease, surgery affords pathologic staging, thereby facilitating the selective application of secondary therapies, and has been associated with decreased mortality risk versus radiation in retrospective series. Reported functional outcomes after surgery, particularly urinary continence and erectile dysfunction, have varied greatly to date. These assessments have been limited by nonstandardized reporting methodology. The use of robot-assisted radical prostatectomy has increased in recent years, and while follow-up is thus far short, available data do not suggest the superiority of either approach in terms of functional or oncologic outcomes. CONCLUSIONS RP is associated with excellent long-term cancer control. Continued efforts to conduct prospective assessments of postoperative functional outcomes are necessary using validated QoL instruments. The importance of surgical approach will also require further study, incorporating comparative oncologic, functional, and economic data.

Robotic Radical Prostatectomy in Overweight and Obese Patients: Oncological and Validated-Functional Outcomes

OBJECTIVES To determine the impact of body mass index (BMI) on perioperative functional and oncological outcomes in patients undergoing robotic laparoscopic radical prostatectomy (RLRP) when stratified by BMI. METHODS Data were collected prospectively for 945 consecutive patients undergoing RLRP. Patients were evaluated with the UCLA-PCI-SF36v2 validated-quality-of-life questionnaire preoperatively and postoperatively to 24 months. Patients were stratified by BMI as normal weight (BMI < 25 kg/m(2)), overweight (BMI = 25 to < 30 kg/m(2)) and obese (BMI > or = 30 kg/m(2)) for outcomes analysis. RESULTS Preoperatively, obese men had a significantly greater percentage of medical comorbidities (P < .01) as well as a baseline erectile dysfunction (lower mean baseline Sexual Health Inventory for Men score [P = .01] and UCLA-PCI-SF36v2 sexual function domain scores [P = .01]). Mean operative time was significantly longer in obese patients when compared with normal and overweight men (234 minutes vs 217 minutes vs 214 minutes; P = .0003). Although overall complication rates were comparable between groups, a greater incidence of case abortion caused by pneumoperitoneal pressure with excessive airway pressures was noted in obese men. Urinary continence and potency outcomes were significantly lower for obese men at both 12 and 24 months (all P < .05). CONCLUSIONS In this series, obese men experienced a longer operative time, particularly during the initial robotic experience. As such, surgeons early in their RLRP learning curve should proceed cautiously with surgery in these technically more difficult patients or reserve such cases until the learning curve has been surmounted. These details, including inferior urinary and sexual outcomes, should be discussed with obese patients during preoperative counseling.

Comparison of Laparoscopic and Open Partial Nephrectomy in Clinical T1a Renal Tumors

PURPOSE Partial nephrectomy has been established as a standard of care for T(1a) renal tumors. Laparoscopic partial nephrectomy (LPN) has been described as more difficult to perform than open partial nephrectomy (OPN). We compare our series of LPN and OPN. PATIENTS AND METHODS From October 2002 to January 2006, 76 LPNs were performed for patients with clinical T(1a) tumors. These patients were matched with a cohort of patients who underwent OPN for solitary tumors of 4 cm or smaller in diameter. The cohorts were compared with regard to demographics, perioperative data, and outcomes. RESULTS The patient populations were demographically similar. Although mean tumor size was smaller in the laparoscopic cohort (2.5 v 2.9 cm, P=0.002), the OPN cohort demonstrated shorter operative (193 v 225 min, P=0.004) and ischemia times (20.5 v 32.8 min). LPN was associated with less blood loss (212 v 385 mL, P<0.001) and shorter hospital stay (2.5 v 5.6 days, P<0.001), however. One positive margin occurred in each of the LPN and OPN cohorts. Intraoperative complications were similar, although LPN was associated with fewer postoperative complications. Of note, two LPN (2.6%) patients had emergent reoperation and complete nephrectomy because of postoperative hemorrhage. CONCLUSIONS Despite increased operative and ischemia times, LPN patients demonstrated quicker recovery and fewer postoperative complications. Two patients in the LPN group, however, had emergent complete nephrectomy because of hemorrhage. We conclude that LPN is still an evolving alternative to OPN in patients with small renal tumors.

Radical prostatectomy improves progression‐free and cancer‐specific survival in men with lymph node positive prostate cancer in the prostate‐specific antigen era: a confirmatory study

Study Type – Therapy (outcomes research)
Level of Evidence 2b

Trifecta outcomes after robotic-assisted laparoscopic prostatectomy.

OBJECTIVE To evaluate the trifecta outcomes following robotic-assisted laparoscopic prostatectomy (RALP) and compare the results applying definitions of continence and potency as reported in the literature vs validated questionnaire. The trifecta rate of achieving continence, potency, and undetectable prostate-specific antigen (PSA) following radical prostatectomy has been estimated to be approximately 60% at 1-2 years in open radical prostatectomy series. The definitions of continence and potency were not standardized, which poses difficulty in comparing published results. METHODS A prospective, institutional RALP database was analyzed for preoperatively continent and potent men with >/= 1 year follow-up after bilateral nerve-sparing surgery. Continence and potency were evaluated preoperatively and at 3, 6, 12, and 24 months after surgery by surgeon interview (subjective) and using University of California Los-Angeles Prostate Cancer Index self-administered questionnaire (objective). Biochemical recurrence was defined as a detectable (> 0.05 ng/mL), increasing PSA on 2 consecutive tests. RESULTS Among 1362 consecutive RALPs, 380 patients were preoperatively potent and continent underwent surgery with bilateral nerve-sparing technique and had sufficient follow-up. Trifecta rates applying subjective continence and potency definitions were 34%, 52%, 71%, and 76% at 3, 6, 12, and 24 months, respectively. The corresponding trifecta rates using objective continence and potency definitions stood at 16%, 31%, 44%, and 44%. The difference was statistically significant at each time point (P < .0001). CONCLUSIONS RALP provides trifecta outcome rates comparable to open surgery. The outcome rates vary significantly depending on the tools used for continence and potency evaluation.

Length of Positive Surgical Margin After Radical Prostatectomy as a Predictor of Biochemical Recurrence

PURPOSE Length and location of positive surgical margins are independent predictors of biochemical recurrence after open radical prostatectomy. We assessed their impact on biochemical recurrence in a large robotic prostatectomy series. MATERIALS AND METHODS Data were collected prospectively from 1,398 men undergoing robotic radical prostatectomy for clinically localized prostate cancer from 2003 to 2008 at a single institution. The associations of preoperative prostate specific antigen, pathological Gleason score, pathological stage and positive surgical margin parameters (location, length and focality) with biochemical recurrence rate were evaluated. Margin status and length were measured by a single uropathologist. Biochemical recurrence was defined as serum prostate specific antigen greater than 0.1 ng/ml on 2 consecutive tests. Cox regression models were constructed to evaluate predictors of biochemical recurrence. RESULTS Of 1,398 consecutive patients who underwent robotic prostatectomy positive margins were present in 243 (17%) (11% of pathological T2 and 41% of T3). Preoperative prostate specific antigen, pathological stage, Gleason score, margin status, and margin length as a continuous and categorical variable (less than 1, 1 to 3, more than 3 mm) were independent predictors of biochemical recurrence. Patients with negative margins and those with a positive margin less than 1 mm had similar rates of biochemical recurrence (log rank test p = 0.18). Surgical margin location was not independently associated with biochemical recurrence. CONCLUSIONS Margin status and length are independent predictors of biochemical recurrence following robotic radical prostatectomy. Although longer followup and validation studies are necessary for confirmation, patients with a positive margin less than 1 mm appear to have similar recurrence rates as those with negative margins.

Positive surgical margins after robotic assisted radical prostatectomy: A multi-institutional study

PURPOSE Positive surgical margins are an independent predictive factor for biochemical recurrence after radical prostatectomy. We analyzed the incidence of and associative factors for positive surgical margins in a multi-institutional series of 8,418 robotic assisted radical prostatectomies. MATERIALS AND METHODS We analyzed the records of 8,418 patients who underwent robotic assisted radical prostatectomy at 7 institutions. Of the patients 323 had missing data on margin status. Positive surgical margins were categorized into 4 groups, including apex, bladder neck, posterolateral and multifocal. The records of 6,169 patients were available for multivariate analysis. The variables entered into the logistic regression models were age, body mass index, preoperative prostate specific antigen, biopsy Gleason score, prostate weight and pathological stage. A second model was built to identify predictive factors for positive surgical margins in the subset of patients with organ confined disease (pT2). RESULTS The overall positive surgical margin rate was 15.7% (1,272 of 8,095 patients). The positive surgical margin rate for pT2 and pT3 disease was 9.45% and 37.2%, respectively. On multivariate analysis pathological stage (pT2 vs pT3 OR 4.588, p<0.001) and preoperative prostate specific antigen (4 or less vs greater than 10 ng/ml OR 2.918, p<0.001) were the most important independent predictive factors for positive surgical margins after robotic assisted radical prostatectomy. Increasing prostate weight was associated with a lower risk of positive surgical margins after robotic assisted radical prostatectomy (OR 0.984, p<0.001) and a higher body mass index was associated with a higher risk of positive surgical margins (OR 1.032, p<0.001). For organ confined disease preoperative prostate specific antigen was the most important factor that independently correlated with positive surgical margins (4 or less vs greater than 10 ng/ml OR 3.8, p<0.001). CONCLUSIONS The prostatic apex followed by a posterolateral site was the most common location of positive surgical margins after robotic assisted radical prostatectomy. Factors that correlated with cancer aggressiveness, such as pathological stage and preoperative prostate specific antigen, were the most important factors independently associated with an increased risk of positive surgical margins after robotic assisted radical prostatectomy.

Pelvic Lymphadenectomy During Robot-assisted Radical Prostatectomy: Assessing Nodal Yield, Perioperative Outcomes, and Complications

OBJECTIVES To describe our pelvic lymphadenectomy (PLND) technique during robot-assisted radical prostatectomy and to evaluate the nodal yield and perioperative outcomes. PLND is commonly performed with radical prostatectomy for localized prostate cancer. Because of the limitations of the robotic arm pitch in accessing the pelvic sidewall and undersurface of the iliac bifurcation, uro-oncologists have questioned the adequacy of robotic PLND. METHODS PLND was routinely performed on men with higher risk preoperative prostate cancer parameters (ie, prostrate-specific antigen >10 ng/mL, primary Gleason score > or =4, or clinical Stage T2b or greater). The outcomes of robot-assisted radical prostatectomy with bilateral, standard template PLND (group 1; n = 296 [26%]) were compared with those of a cohort of 859 robot-assisted radical prostatectomy patients (74%) without PLND (group 2). We also compared these data with those from a single-surgeon experience of open, standard-template PLND for retropubic radical prostatectomy. RESULTS The mean number of lymph nodes removed was 12.5 (interquartile range 7-16). The mean operative time (224 vs 216 minutes; P = .09), estimated blood loss (206 vs 229 mL; P = .14), and hospital stay (1.32 vs 1.24 days; P = .46) were comparable between the 2 groups. The rate of intraoperative complications (1% vs 1.5%; P = .2), overall postoperative complications (9% vs 7%; P = .8), and lymphocele formation (2% vs 0%; P = .9) were not significantly different. The review of our open series and the historically published open standard-template PLND series revealed a mean yield of 15 and a range of 6.7-15 lymph nodes removed, respectively. CONCLUSIONS Our data support the feasibility and low complication rate of robotic standard-template PLND with lymph node yields comparable to those with open PLND. Considering the low morbidity of PLND in experienced hands, coupled with the potential of preoperative undergrading and understaging and the therapeutic benefit to patients with micrometastatic disease, an increase in overall standard-template PLND use should be considered.

Artery-Only Occlusion May Provide Superior Renal Preservation During Laparoscopic Partial Nephrectomy

OBJECTIVES Artery-only occlusion (AO) has been used during nephron-sparing surgery to reduce ischemic damage. However, this has not been demonstrated in laparoscopic partial nephrectomy (LPN). We compared our experience with AO and both artery and vein occlusion (AV) in LPN to optimize the method of ischemia. METHODS This retrospective case-control study identified 25 patients who underwent AO during LPN and matched them to a cohort of 53 patients who underwent LPN with AV. The groups were compared for ischemia time, blood loss, transfusion rate, and renal function. RESULTS The 2 cohorts were comparable on demographic data. Blood loss was similar, with AO and AV demonstrating equivalent transfusion rates. The 2 cohorts had similar warm ischemia times. Positive margin rate was not affected by venous backflow in the AO cohort (0% AO vs 1.9% AV, P = .679). No significant postoperative change in creatinine (Cr) or creatinine clearance (CrCl) was seen for AO; however, a significant change in Cr and CrCl was seen in AV. CONCLUSIONS AO during LPN does not lead to a greater blood loss or an increased warm ischemia time. The benefit of AO on renal function is significant and requires further investigation.