Safety profile of robot-assisted radical prostatectomy: a standardized report of complications in 3317 patients

Background

Previous studies attempting to assess complications after robot-assisted radical prostatectomy (RARP) are limited by their small numbers, short follow-up, or lack of risk factor analysis.

Objective

To document complications after RARP by strict application of standardized reporting criteria.

Design, setting, and participants

Between January 2005 and December 2009, 3317 consecutive patients underwent RARP at a tertiary referral center. Median follow-up was 24.2 mo (interquartile range: 12.4–36.9).

Intervention

Transperitoneal RARP was performed by one of five surgeons—two experienced, three beginners.

Measurements

Complications were captured by exhaustive review of multiple datasets, including our prospective prostate cancer database, claims data, and electronic medical and institutional morbidity and mortality records, and reported according to the Martin–Donat criteria. Complications were stratified by type (medical/surgical), Clavien classification, and timing of onset. Multivariable analysis of factors predictive of complications was performed.

Results and limitations

The median hospitalization time was 1 d. There were 368 complications in 326 patients (9.8%), including a transfusion rate of 2.2%. We detected 79 medical complications in 78 patients (2.4%) and 289 surgical complications in 264 patients (8.0%). There were 242 minor (Clavien 1–2) and 126 major (Clavien 3–5) complications. Two hundred ninety-nine (81.3%) complications occurred within 30 d, 17 (4.6%) within 31–90 d, and 52 (14.1%) after 90 d from surgery. On multivariable analysis, preoperative prostate-specific antigen values and cardiac comorbidity were predictive for medical complications, whereas age, gastroesophageal reflux disease, and biopsy Gleason score were predictive of surgical complications. Limitations of this study include representing results from a single high-volume referral center and not including the learning curve of the two most experienced surgeons.

Conclusions

RARP is a safe operation, with an overall complication rate of 9.8%. Most complications occurred within 30 d of surgery.     

Pelvic Lymph Node Dissection During Robot-assisted Radical Prostatectomy: Efficacy,Limitations, and Complications—A Systematic Review of the Literature

Context

Pelvic lymph node dissection (PLND) in prostate cancer is the most effective method for detecting lymph node metastases. However, a decline in the rate of PLND during radical prostatectomy (RP) has been noted. This is likely the result of prostate cancer stage migration in the prostate-specific antigen-screening era, and the introduction of minimally invasive approaches such as robot-assisted radical prostatectomy (RARP).

Objective

To assess the efficacy, limitations, and complications of PLND during RARP.

Evidence acquisition

A review of the literature was performed using the Medline, Scopus, and Web of Science databases with no restriction of language from January 1990 to December 2012. The literature search used the following terms: prostate cancer, radical prostatectomy, robot-assisted, and lymph node dissection.

Evidence synthesis

The median value of nodal yield at PLND during RARP ranged from 3 to 24 nodes. As seen in open and laparoscopic RP series, the lymph node positivity rate increased with the extent of dissection during RARP. Overall, PLND-only related complications are rare. The most frequent complication after PLND is symptomatic pelvic lymphocele, with occurrence ranging from 0% to 8% of cases. The rate of PLND-associated grade 3–4 complications ranged from 0% to 5%. PLND is associated with increased operative time. Available data suggest equivalence of PLND between RARP and other surgical approaches in terms of nodal yield, node positivity, and intraoperative and postoperative complications.

Conclusions

PLND during RARP can be performed effectively and safely. The overall number of nodes removed, the likelihood of node positivity, and the types and rates of complications of PLND are similar to pure laparoscopic and open retropubic procedures.     

Complications After Robot-assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium

Background

Complication reporting is highly variable and nonstandardized. Therefore, it is imperative to determine the surgical outcomes of major oncologic procedures.

Objective

To describe the complications after robot-assisted radical cystectomy (RARC) using a standardized and validated reporting methodology.

Design, setting, and participants

Using the International Robotic Cystectomy Consortium (IRCC) database, we identified 939 patients who underwent RARC, had available complication data, and had at least 90 d of follow-up.

Outcome measurements and statistical analysis

Complications were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center (MSKCC) system and were defined and stratified by organ system. Secondary outcomes included identification of preoperative and intraoperative variables predicting complications. Logistic regression models were used to define predictors of complications and readmission.

Results and limitations

Forty-one percent (n = 387) and 48% (n = 448) of patients experienced a complication within 30 and 90 d of surgery, respectively. The highest grade of complication was grade 0 in 52%, grade 1–2 in 29%, and grade 3–5 in 19% patients. Gastrointestinal, infectious, and genitourinary complications were most common (27%, 23%, and 17%, respectively). On multivariable analysis, increasing age group, neoadjuvant chemotherapy, and receipt of blood transfusion were independent predictors of any and high-grade complications, respectively. Thirty and 90-d mortality was 1.3% and 4.2%, respectively. As a multi-institutional database, a disparity in patient selection, operating standards, postoperative management, and reporting of complications can be considered a major limitation of the study.

Conclusions

Surgical morbidity after RARC is significant when reported using a standardized reporting methodology. The majority of complications are low grade. Strict reporting of complications is necessary to advocate for radical cystectomy (RC) and helps in patient counseling.     

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.     

Comparative Effectiveness of Robot-assisted Versus Open Radical Prostatectomy Cancer Control

Background

Robot-assisted radical prostatectomy (RARP) remains controversial, and no improvement in cancer control outcomes has been demonstrated over open radical prostatectomy (ORP).

Objective

To examine population-based, comparative effectiveness of RARP versus ORP pertaining surgical margin status and use of additional cancer therapy.

Design, setting, and participants

This was a retrospective observational study of 5556 RARP and 7878 ORP cases from 2004 to 2009 from Surveillance Epidemiology and End Results–Medicare linked data.

Intervention

RARP versus ORP.

Outcome measurements and statistical analysis

Propensity-based analyses were performed to minimize treatment selection biases. Generalized linear regression models were computed for comparison of RP surgical margin status and use of additional cancer therapy (radiation therapy [RT] or androgen deprivation therapy [ADT]) by surgical approach.

Results and limitations

In the propensity-adjusted analysis, RARP was associated with fewer positive surgical margins (13.6% vs 18.3%; odds ratio [OR]: 0.70; 95% confidence interval [CI], 0.66–0.75), largely because of fewer RARP positive margins for intermediate-risk (15.0% vs 21.0%; OR: 0.66; 95% CI, 0.59–0.75) and high-risk (15.1% vs 20.6%; OR: 0.70; 95% CI, 0.63–0.77) disease. In addition, RARP was associated with less use of additional cancer therapy within 6 mo (4.5% vs 6.2%; OR: 0.75; 95% CI, 0.69–0.81), 12 mo (OR: 0.73; 95% CI, 0.62–0.86), and 24 mo (OR: 0.67; 95% CI, 0.57–0.78) of surgery. Limitations include the retrospective nature of the study and the absence of prostate-specific antigen levels to determine biochemical recurrence.

Conclusions

RARP is associated with improved surgical margin status relative to ORP for intermediate- and high-risk disease and less use of postprostatectomy ADT and RT. This has important implications for quality of life, health care delivery, and costs.

Patient summary

Robot-assisted radical prostatectomy (RP) versus open RP is associated with fewer positive margins and better early cancer control because of less use of additional androgen deprivation and radiation therapy within 2 yr of surgery.     

Perioperative outcomes of robot-assisted radical prostatectomy compared with open radical prostatectomy: results from the nationwide inpatient sample

Background

Prior to the introduction and dissemination of robot-assisted radical prostatectomy (RARP), population-based studies comparing open radical prostatectomy (ORP) and minimally invasive radical prostatectomy (MIRP) found no clinically significant difference in perioperative complication rates.

Objective

Assess the rate of RARP utilization and reexamine the difference in perioperative complication rates between RARP and ORP in light of RARP's supplanting laparoscopic radical prostatectomy (LRP) as the most common MIRP technique.

Design, setting, and participants

As of October 2008, a robot-assisted modifier was introduced to denote robot-assisted procedures. Relying on the Nationwide Inpatient Sample between October 2008 and December 2009, patients treated with radical prostatectomy (RP) were identified. The robot-assisted modifier (17.4x) was used to identify RARP (n = 11 889). Patients with the minimally invasive modifier code (54.21) without the robot-assisted modifier were classified as having undergone LRP and were removed from further analyses. The remainder were classified as ORP patients (n = 7389).

Intervention

All patients underwent RARP or ORP.

Measurements

We compared the rates of blood transfusions, intraoperative and postoperative complications, prolonged length of stay (pLOS), and in-hospital mortality. Multivariable logistic regression analyses of propensity score–matched populations, fitted with general estimation equations for clustering among hospitals, further adjusted for confounding factors.

Results and limitations

Of 19 462 RPs, 61.1% were RARPs, 38.0% were ORPs, and 0.9% were LRPs. In multivariable analyses of propensity score–matched populations, patients undergoing RARP were less likely to receive a blood transfusion (odds ratio [OR]: 0.34; 95% confidence interval [CI], 0.28–0.40), to experience an intraoperative complication (OR: 0.47; 95% CI, 0.31–0.71) or a postoperative complication (OR: 0.86; 95% CI, 0.77–0.96), and to experience a pLOS (OR: 0.28; 95% CI, 0.26–0.30). Limitations of this study include lack of adjustment for tumor characteristics, surgeon volume, learning curve effect, and longitudinal follow-up.

Conclusions

RARP has supplanted ORP as the most common surgical approach for RP. Moreover, we demonstrate superior adjusted perioperative outcomes after RARP in virtually all examined outcomes.     

Defining morbidity of robot-assisted radical cystectomy using a standardized reporting methodology

Background

Adverse event reporting is highly variable and nonstandardized in urologic literature, especially for robot-assisted radical cystectomy (RARC).

Objective

We sought to better characterize complications in patients after RARC using a standardized reporting methodology.

Design, setting, and participants

Using a prospectively maintained, single-institution database, we identified 156 consecutive patients who underwent RARC with at least 90 d of follow-up. Complications were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center (MSKCC) system and were defined and stratified by organ system.

Measurements

Logistic regression models were used to define predictors of complications. Cox proportional hazard modeling and Kaplan-Meier survival analyses were used to correlate complications and 90-d mortality.

Results and limitations

Fifty-two percent (81 of 156) of patients experienced a complication within 90 d of surgery. Sixty-five percent (102 of 156) of patients experienced a postoperative complication at a median follow-up of 9 mo. The highest grade of complication was grade 1 in 30 patients (19%), grade 2 in 34 patients (22%), and grade 3–5 in 38 patients (24%). Twenty-one percent (33 of 156) of patients required hospital readmission. Gastrointestinal, infectious, and genitourinary complications were most common (31%, 25%, and 13%, respectively). The 90-d mortality rate was 5.8%.

Conclusions

When reported using strict guidelines, surgical morbidity after RARC is significant, but the majority of complications are low grade. Despite the high prevalence of low-grade complications, the mortality rate was acceptably low. Stringent reporting of complications after RARC is essential for counseling patients, assessing surgical quality, and allowing comparisons with open radical cystectomy and among institutions.     

Systematic Review and Meta-analysis of Perioperative Outcomes and Complications After Robot-assisted Radical Prostatectomy

Context

Perioperative complications are a major surgical outcome for radical prostatectomy (RP).

Objective

Evaluate complication rates following robot-assisted RP (RARP), risk factors for complications after RARP, and surgical techniques to improve complication rates after RARP. We also performed a cumulative analysis of all studies comparing RARP with retropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications.

Evidence acquisition

A systematic review of the literature was performed in August 2011, searching Medline, Embase, and Web of Science databases. A free-text protocol using the term radical prostatectomy was applied. The following limits were used: humans; gender (male); and publications dating from January 1, 2008. A cumulative analysis was conducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK).

Evidence synthesis

We retrieved 110 papers evaluating oncologic outcomes following RARP. Overall mean operative time is 152 min; mean blood loss is 166 ml; mean transfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stay is 1.9 d. The mean complication rate was 9%, with most of the complications being of low grade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are the most prevalent surgical complications. Blood loss (weighted mean difference: 582.77; p < 0.00001) and transfusion rate (odds ratio [OR]: 7.55; p < 0.00001) were lower in RARP than in RRP, whereas only transfusion rate (OR: 2.56; p = 0.005) was lower in RARP than in LRP. All the other analyzed parameters were similar, regardless of the surgical approach.

Conclusions

RARP can be performed routinely with a relatively small risk of complications. Surgical experience, clinical patient characteristics, and cancer characteristics may affect the risk of complications. Cumulative analyses demonstrated that blood loss and transfusion rates were significantly lower with RARP than with RRP, and transfusion rates were lower with RARP than with LRP, although all other features were similar regardless of the surgical approach.     

A contemporary update on pathology reporting for prostate cancer: biopsy and radical prostatectomy specimens

Context

The diagnosis of and reporting parameters for prostate cancer (PCa) have evolved over time, yet they remain key components in predicting clinical outcomes.

Objective

Update pathology reporting standards for PCa.

Evidence acquisition

A thorough literature review was performed for articles discussing PCa handling, grading, staging, and reporting published as of September 15, 2011. Electronic articles published ahead of print were also considered. Proceedings of recent international conferences addressing these areas were extensively reviewed.

Evidence synthesis

Two main areas of reporting were examined: (1) prostatic needle biopsy, including handling, contemporary Gleason grading, extent of involvement, and high-risk lesions/precursors and (2) radical prostatectomy (RP), including sectioning, multifocality, Gleason grading, staging of organ-confined and extraprostatic disease, lymph node involvement, tumor volume, and lymphovascular invasion. For each category, consensus views, controversial areas, and clinical import were reviewed.

Conclusions

Modern prostate needle biopsy and RP reports are extremely detailed so as to maximize clinical utility. Accurate diagnosis of cancer-specific features requires up-to-date knowledge of grading, quantitation, and staging criteria. While some areas remain controversial, efforts to codify existing knowledge have had a significant impact on pathology practice.     

Pentafecta: a new concept for reporting outcomes of robot-assisted laparoscopic radical prostatectomy

Background

Widespread use of prostate-specific antigen screening has resulted in younger and healthier men being diagnosed with prostate cancer. Their demands and expectations of surgical intervention are much higher and cannot be adequately addressed with the classic trifecta outcome measures.

Objective

A new and more comprehensive method for reporting outcomes after radical prostatectomy, the pentafecta, is proposed.

Design, setting, and participants

From January 2008 through September 2009, details of 1111 consecutive patients who underwent robot-assisted radical prostatectomy performed by a single surgeon were retrospectively analyzed. Of 626 potent men, 332 who underwent bilateral nerve sparing and who had 1 yr of follow-up were included in the study group.

Measurements

In addition to the traditional trifecta outcomes, two perioperative variables were included in the pentafecta: no postoperative complications and negative surgical margins. Patients who attained the trifecta and concurrently the two additional outcomes were considered as having achieved the pentafecta. A logistic regression model was created to evaluate independent factors for achieving the pentafecta.

Results and limitations

Continence, potency, biochemical recurrence–free survival, and trifecta rates at 12 mo were 96.4%, 89.8%, 96.4%, and 83.1%, respectively. With regard to the perioperative outcomes, 93.4% had no postoperative complication and 90.7% had negative surgical margins. The pentafecta rate at 12 mo was 70.8%. On multivariable analysis, patient age (p = 0.001) was confirmed as the only factor independently associated with the pentafecta.

Conclusions

A more comprehensive approach for reporting prostate surgery outcomes, the pentafecta, is being proposed. We believe that pentafecta outcomes more accurately represent patients’ expectations after minimally invasive surgery for prostate cancer. This approach may be beneficial and may be used when counseling patients with clinically localized disease.     

Cancer control and functional outcomes after radical prostatectomy as markers of surgical quality: analysis of heterogeneity between surgeons at a single cancer center

Background

Previous studies have shown that complications and biochemical recurrence rates after radical prostatectomy (RP) vary between different surgeons to a greater extent than might be expected by chance. Data on urinary and erectile outcomes, however, are lacking.

Objective

In this study, we examined whether between-surgeon variation, known as heterogeneity, exists for urinary and erectile outcomes after RP.

Design, setting, and participants

Our study consisted of 1910 RP patients who were treated by 1 of 11 surgeons between January 1999 and July 2007.

Intervention

All patients underwent RP at Memorial Sloan-Kettering Cancer Center.

Measurements

Patients were evaluated for functional outcome 1 yr after surgery. Multivariable random effects models were used to evaluate the heterogeneity in erectile or urinary outcome between surgeons, after adjustment for case mix (age, prostate-specific antigen, pathologic stage and grade, comorbidities) and year of surgery.

Results and limitations

We found significant heterogeneity in functional outcomes after RP (p < 0.001 for both urinary and erectile function). Four surgeons had adjusted rates of full continence <75%, whereas three had rates >85%. For erectile function, two surgeons in our series had adjusted rates <20%; another two had rates >45%. We found some evidence suggesting that surgeons’ erectile and urinary outcomes were correlated. Contrary to the hypothesis that surgeons “trade off” functional outcomes and cancer control, better rates of functional preservation were associated with lower biochemical recurrence rates.

Conclusions

A patient's likelihood of recovering erectile and urinary function may differ depending on which of two surgeons performs his RP. Functional preservation does not appear to come at the expense of cancer control; rather, both are related to surgical quality.     

A Multinational,Multi-institutional Study Comparing Positive Surgical Margin Rates Among 22 393 Open,Laparoscopic, and Robot-assisted Radical Prostatectomy Patients

Background

Positive surgical margins (PSMs) are a known risk factor for biochemical recurrence in patients with prostate cancer (PCa) and are potentially affected by surgical technique and volume.

Objective

To investigate whether radical prostatectomy (RP) modality and volume affect PSM rates.

Design, setting, and participants

Fourteen institutions in Europe, the United States, and Australia were invited to participate in this study, all of which retrospectively provided margins data on 9778 open RP, 4918 laparoscopic RP, and 7697 robotic RP patients operated on between January 2000 and October 2011.

Outcome measurements and statistical analyses

The outcome measure was PSM rate. Multivariable logistic regression analyses and propensity score methods identified odds ratios for risk of a PSM for one modality compared with another, after adjustment for age, preoperative prostate-specific antigen, postoperative Gleason score, pathologic stage, and year of surgery. Classic adjustment using standard covariates was also implemented to compare PSM rates based on center volume for each minimally invasive surgical cohort.

Results and limitations

Open RP patients had higher-risk PCa at time of surgery on average and were operated on earlier in the study time period on average, compared with minimally invasive cohorts. Crude margin rates were lowest for robotic RP (13.8%), intermediate for laparoscopic RP (16.3%), and highest for open RP (22.8%); significant differences persisted, although were ameliorated, after statistical adjustments. Lower-volume centers had increased risks of PSM compared with the highest-volume center for both laparoscopic RP and robotic RP. The study is limited by its nonrandomized nature; missing data across covariates, especially year of surgery in many of the open cohort cases; lack of standardized histologic processing and central pathology review; and lack of information regarding potential confounders such as patient comorbidity, nerve-sparing status, lymph node status, tumor volume, and individual surgeon caseload.

Conclusions

This multinational, multi-institutional study of 22 393 patients after RP suggests that PSM rates might be lower after minimally invasive techniques than after open RP and that PSM rates are affected by center volume in laparoscopic and robotic cases.

Patient summary

In this study, we compared the effectiveness of different types of surgery for prostate cancer by looking at the rates of cancer cells left at the margins of what was removed in the operations. We compared open, keyhole, and robotic surgery from many centers across the globe and found that robotic and keyhole operations appeared to have lower margin rates than open surgeries. How many cases a center and surgeon do seems to affect this rate for both robotic and keyhole procedures.     

Komplikationen bei radikalen retropubischen Prostatektomien anhand der Martin-Kriterien

Background

In 2002 the ten Martin criteria were proposed which should be met when reporting complications following surgery. Only a few studies have evaluated complication rates after open retropubic radical prostatectomy using these criteria. In this study we report on complications of open retropubic radical prostatectomy using the standardized Clavien-Dindo reporting methodology.

Patients and methods

The overall complication rate was 28.6% (907 of 3,172). We registered 1,069 medical or surgical complications in 907 patients. Of these, 714 complications were grade I (66.8%), 195 grade II (18.2%), 139 grade III (13%), and 17 grade IV (1.6%), respectively. The mortality rate (grade V) was 0.1% (4 of 3,172). Older age (hazard ratio 1.049, p=0.023) and a performed lymphadenectomy (hazard ratio 1.804, p=0.024) were independent predictors for high-grade complications (grade III or greater) on multivariate analysis.

Results

Between 08/2003 and 06/2010 complications of 3172 consecutive men who underwent open retropubic radical prostatectomy at a single center were recorded prospectively. Complications which occurred within a period of 30 days postoperatively were graded retrospectively according to the Clavien-Dindo classification. Clinical and histopathological risk factors were statistically evaluated for an association with complication grades. All 10 Martin criteria were fulfilled.

Conclusions

Using the Clavien-Dindo classification as a standardized reporting methodology, we observed an acceptable overall complication rate of 28.6%. In the majority (85% of all complications) lower grade complications occurred. In this series older age and a lymphadenectomy were risk factors for high-grade complications (III-V). A patient??s age remains an important factor when considering the indication for radical prostatectomy.     

Positive surgical margins in radical prostatectomy: outlining the problem and its long-term consequences

Context

This review focuses on positive surgical margins (PSM) in radical prostatectomy (RP).

Objective

To address the etiology, incidence, and oncologic impact of PSM and discuss technical points to help surgeons minimize their positive margin rate. An evidence-based approach to assist clinicians in counseling patients with a PSM is provided.

Evidence acquisition

A literature search in English was performed using the National Library of Medicine database and the following key words: prostate cancer, surgical margins, and radical prostatectomy. Seven hundred sixty-eight references were scrutinized, and 73 were selected for rigorous review based on their pertinence, study size, and overall contribution to the field.

Evidence synthesis

In contemporary series, PSM are reported in 11–38% of patients undergoing RP. Although variability exists in the pathologic interpretation of surgical margins, PSM are associated with an increased hazard of biochemical recurrence (BCR) and local disease recurrence as well as the need for secondary cancer treatment. A posterolateral PSM appears to confer the greatest risk of recurrence, whereas the prognostic significance of positive apical margins remains controversial. The role of preoperative imaging and intraoperative frozen section analysis are being investigated to reduce margin positivity rates. Level-1 evidence indicates that adjuvant radiotherapy (RT) in men with PSM reduces BCR rates and clinical progression and possibly improves overall survival (OS).

Conclusions

PSM in RP specimens are uniformly considered an adverse outcome. Regardless of approach (open or laparoscopic), attention to surgical detail is essential to minimize rates. For patients with a PSM destined to experience a cancer recurrence, RT is the only established treatment with curative potential. A randomized trial in patients with PSM comparing immediate postoperative RT to salvage RT is critically needed before definitive recommendations can be made.     

Long-Term Rates of Undetectable PSA with Initial Observation and Delayed Salvage Radiotherapy after Radical Prostatectomy

Background

Randomized trials have shown an improvement in progression-free survival rates with adjuvant radiation therapy (ART) after radical prostatectomy for patients with a high risk of cancer recurrence. Less is known about the relative advantages and disadvantages of initial observation with delayed salvage radiation therapy (SRT).

Objective

To examine the results of SRT in a large single-surgeon radical prostatectomy series.

Design, Setting, and Participants

From a radical prostatectomy database, we identified 859 men with positive surgical margins (SM+), extracapsular tumor extension (ECE), or seminal vesicle invasion (SVI) who chose to defer ART. Following a period of initial observation, 192 ultimately received SRT for prostate-specific antigen (PSA) progression.

Measurements

Survival analysis was performed to examine the outcomes of initial observation followed by SRT.

Results and Limitations

In patients with SM+/ECE and SVI, the 7-yr PSA progression-free survival rates with observation were 62% and 32%, respectively. Among those who had PSA progression, 56% and 26%, respectively, maintained an undetectable PSA for 5 yr after SRT. The long-term rates of undetectable PSA associated with an SRT strategy were 83% and 50% for men with SM+/ECE and SVI, respectively. In the subset of 716 men who did not receive any hormonal therapy, the corresponding long-term rates of undetectable PSA were 91% and 75%, respectively.

Conclusions

Following radical prostatectomy, initial observation followed by delayed SRT at the time of PSA recurrence is an effective strategy for selected patients with SM+/ECE. Some patients with SVI may also benefit from this strategy. However, additional prospective studies are necessary to further examine the survival outcomes following SRT.     

Robotic Laparoendoscopic Single-Site Radical Prostatectomy: Technique and Early Outcomes

Background

Laparoendoscopic single-site (LESS) surgery is challenging. To help overcome current technical and ergonomic limitations, the da Vinci robotic platform can be applied to LESS.

Objectives

Our aim was to describe the surgical technique and to report the early outcomes of robotic LESS (R-LESS) radical prostatectomy (RP).

Design, setting, and participants

A retrospective review of prospectively captured R-LESS RP data was performed between May 2008 and May 2010. A total of 20 procedures were scheduled (12 with and 8 without pelvic lymph node dissection).

Surgical procedure

R-LESS prostatectomy was performed using the methods outlined in the paper and in the supplemental video material.

Interventions

All patients underwent R-LESS RP by one high-volume surgeon. Single-port access was achieved via a commercially available multichannel port. The da Vinci S and da Vinci Si surgical platform was used with pediatric and standard instruments.

Measurements

Preoperative, perioperative, pathologic, and functional outcomes data were analyzed.

Results and limitations

The mean age was 60.4 yr; body mass index was 25.4 kg/m². The mean operative time was 189.5 min; estimated blood loss was 142.0 ml. The average length of stay was 2.7 d, and the visual analog pain score at discharge was 1.4 of 10. Four focal positive margins were encountered, with two occurring during the first three cases. Pathology revealed a Gleason score of 3 + 3 in 3 patients, 3 + 4 in 11 patients, 4 + 3 in 4 patients, and 4 + 4 in 2 patients. There were a total of four complications according to the Clavien system including one grade 1, two grade 2, and one grade 4. The median follow-up has been 4 mo (range: 1–24 mo). Study limitations include the small sample size, the short follow-up, and the lack of comparative cohort.

Conclusions

The R-LESS RP is technically feasible and reduces some of the difficulties encountered with conventional LESS RP.     

Standardized Analysis of Frequency and Severity of Complications After Robot-assisted Radical Cystectomy

Background

Comprehensive and standardized reporting of adverse events after robot-assisted radical cystectomy (RARC) and urinary diversion for bladder cancer is necessary to evaluate the magnitude of morbidity for this complex operation.

Objective

To accurately identify and assess postoperative morbidity after RARC using a standardized reporting system.

Design, setting, and participants

A total of 241 consecutive patients underwent RARC, extended pelvic lymph node dissection, and urinary diversion between 2003 and 2011. In all, 196 patients consented to a prospective database, and they are the subject of this report. Continent diversions were performed in 68% of cases.

Outcome measurements and statistical analysis

All complications within 90 d of surgery were defined and categorized by a five-grade and 10-domain modification of the Clavien system. Univariable and multivariable logistic regression analyses were used to identify predictors of complications. Grade 1–2 complications were categorized as minor, and grade 3–5 complications were categorized as major. All blood transfusions were recorded as grade ≥2.

Results and limitations

Eighty percent of patients (156 of 196 patients) experienced a complication of any grade ≤90 d after surgery. A total of 475 adverse events (113 major) were recorded, with 365 adverse events (77%) occurring ≤30 d after surgery. Sixty-eight patients (35%) experienced a major complication within the first 90 d. Other than blood transfusions given (86 patients [43.9%]), infectious, gastrointestinal, and procedural complications were the most common, at 16.2%, 14.1%, and 10.3%, respectively. Age, comorbidity, preoperative hematocrit, estimated blood loss, and length of surgery were predictive of a complication of any grade, while comorbidity, preoperative hematocrit, and orthotopic diversion were predictive of major complications. The 90-d mortality rate was 4.1%. The main limitation is lack of a control group.

Conclusions

Analysis of postoperative morbidity following RARC demonstrates a considerable complication rate, though the rate is comparable to contemporary open series that followed similar reporting guidelines. This finding reinforces the need for complete and standardized reporting when evaluating surgical techniques and comparing published series.     

Survival Benefit of Radical Prostatectomy in Lymph Node–Positive Patients with Prostate Cancer

Background

Positive lymph node (LN) status is considered a systemic disease state. In prostate cancer, LN-positive diagnosis during pelvic LN dissection (PLND) potentially leads to the abandonment of radical prostatectomy (RP).

Objective

To compare the overall survival (OS) and relative survival (RS; as an estimate for cancer-specific survival) in LN-positive patients with or without RP.

Design, setting, and participants

Between 1988 and 2007, a total of 35 629 men with prostate cancer were identified at the Munich Cancer Registry; of those, 1413 patients had positive LNs.

Intervention

Of these 1413 LN-positive patients, prostatectomy was abandoned in 456 LN-positive patients, whereas 957 underwent RP despite the LN-positive finding.

Measurements

Crucial analyses are based on 938 LN-positive patients (688 with RP and 250 without RP) with complete data regarding age, grade, and prostate-specific antigen (PSA). OS (Kaplan-Meier estimates) and RS are presented, and Cox regression analysis was used to show the influence of predictors such as clinical stage, age at surgery, number of positive LNs, PSA level, grade, and extent of surgery.

Results

Median follow-up was 5.6 yr. OS of patients at 5 yr and 10 yr was 84% and 64%, respectively, with RP and was 60% and 28%, respectively, with aborted RP. The RS of patients at 5 yr and 10 yr was 95% and 86%, respectively, with RP and was 70% and 40%, respectively, with abandoned surgery. There was an imbalance, however, in the number of positive LNs: 17.2% with RP had four or more positive nodes versus 28% in the patient group without RP. In the multivariate model, RP was a strong independent predictor of survival (hazard ratio: 2.04 [95% confidence interval, 1.59–2.63; p < 0.0001]).

Conclusion

LN-positive patients with complete RP had improved survival compared to patients with abandoned RP. These results suggest that RP may have a survival benefit and the abandonment of RP in node-positive cases may not be justified.     

Photodynamic Diagnosis Using 5-Aminolevulinic Acid for the Detection of Positive Surgical Margins during Radical Prostatectomy in Patients with Carcinoma of the Prostate: A Multicentre, Prospective, Phase 2 Trial of a Diagnostic Procedure

Background

Surgical margin status after radical prostatectomy (RP) is a significant risk factor for tumour recurrence. It is an intriguing concept to find a fluorescence marker for photodynamic diagnosis (PDD) to make tumour margins visible during surgery.

Objective

To investigate the feasibility of identification of positive surgical margins (PSM) during open retropubic or endoscopic extraperitoneal RP by 5-aminolevulinic acid (5-ALA)–induced protoporphyrin IX (PpIX) to enhance surgical radicality.

Design, setting, and participants

Thirty-nine patients (Gleason score 6–10, prostate-specific antigen [PSA] 2.3–120 ng/ml) received 20 mg/kg of body weight of 5-ALA orally and underwent RP (24 endoscopic extraperitoneal, 15 open retropubic).

Measurements

A PDD-suitable laparoscopy optic (Karl-Storz GmbH, Tuttlingen, Germany) with a yellow long-pass filter was coupled to a fibre-optic light cord with an excitation light source (380–420 nm, D-Light, Karl-Storz GmbH, Tuttlingen, Germany) for fluorescence excitation of PpIX and to a PDD-suitable camera for video and photo documentation by the AIDA DVD system (Karl-Storz GmbH, Tuttlingen, Germany).

Results and limitations

There were more false-negative cases in the open group (four vs two) than in the endoscopic group but more false-positive cases in the endoscopic group (two vs none) than in the open group. The overall sensitivity and specificity were 56% and 91.6%, respectively. The sensitivity of the endoscopic cases was much higher (75% vs 38%) than for the open cases, while the specificity was higher for the open group (88.2% vs 100%).

Conclusions

PDD with 5-ALA–induced PpIX during RP might be a feasible and effective method for reducing the rate of PSM. The technique seems to be more practicable during endoscopic RP rather than open RP. Further clinical studies with higher patient volumes and further development of the technique seem justified.

Trial registration

EudraCT: 2005-004406-93.