Prospective randomised non-inferiority trial of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy.

OBJECTIVE: To determine if eliminating the prophylactic placement of a pelvic drain (PD) after robot-assisted radical prostatectomy (RARP) affects the incidence of early (90-day) postoperative adverse events. PATIENTS AND METHODS: In this parallel-group, blinded, non-inferiority trial, we randomised patients planning to undergo RARP to one of two arms: no drain placement (ND) or PD placement. Patients with demonstrable intraoperative leakage upon bladder irrigation were excluded. Randomisation sequence was determined a priori using a computer algorithm, and included a stratified design with respect to low vs intermediate/high D'Amico risk classifications. Surgeons remained blinded to the randomisation arm until final eligibility was verified at the end of the RARP. The primary endpoint was overall incidence of 90-day complications which, based on our standard treatment using PD retrospectively, was estimated at 13%. The non-inferiority margin was set at 10%, and the planned sample size was 312. An interim analysis was planned and conducted when one-third of the planned accrual and follow-up was completed, to rule out futility if the delta margin was in excess of 0.1389. RESULTS: From 2012 to 2016, 189 patients were accrued to the study, with 92 patients allocated to the ND group and 97 to the PD group. Due to lower than expected accrual rates, accrual to the study was halted by regulatory entities, and we did not reach the intended accrual goal. The ND and PD groups were comparable for median PSA level (6.2 vs 5.8 ng/mL, P = 0.5), clinical stage (P = 0.8), D'Amico risk classification (P = 0.4), median lymph nodes dissected (17 vs 18, P = 0.2), and proportion of patients receiving an extended pelvic lymph node dissection (70.7% vs 79.4%, P = 0.3). Incidence of 90-day overall and major (Clavien-Dindo grade >III) complications in the ND group (17.4% and 5.4%, respectively) was not inferior to the PD group (26.8% and 5.2%, respectively; P < 0.001 and P = 0.007 for difference of proportions <10%, respectively). Symptomatic lymphocoele rates (2.2% in the ND group, 4.1% in the PD group) were comparable between the two arms (P = 0.7). CONCLUSIONS: Incidence of adverse events in the ND group was not inferior to the group who received a PD. In properly selected patients, PD placement after RARP can be safely withheld without significant additional morbidity.

Management of Small Renal Masses.

With the ubiquitous use of cross-sectional abdominal imaging in recent years, the incidence of small renal masses (SRMs) has increased, and the evaluation and management of SRMs have become important clinical issues. Diagnosing a mass in the early stages theoretically allows for high rates of cure but simultaneously risks overtreatment. In the past 20 years, surgical treatment of SRMs has transitioned from radical nephrectomy for all renal tumors, regardless of size, to elective partial nephrectomy whenever technically feasible. Additionally, newer approaches, including renal mass biopsy, active surveillance for select patients, and renal mass ablation, have been increasingly used. In this chapter, we review the current evidence-based papers covering aspects of the diagnosis and management of SRMs.

Enhanced Recovery After Surgery for Radical Cystectomy.

Even with advances in perioperative medical care, anesthetic management, and surgical techniques, radical cystectomy (RC) continues to be associated with a high morbidity rate as well as a prolonged length of hospital stay. In recent years, there has been great interest in identifying multimodal and interdisciplinary strategies that help accelerate postoperative convalescence by reducing variation in perioperative care of patients undergoing complex surgeries. Enhanced recovery after surgery (ERAS) attempts to evaluate and incorporate scientific evidence for modifying as many of the factors contributing to the morbidity of RC as possible, and optimize how patients are cared for before and after surgery. In this chapter, we review the preoperative, intraoperative and postoperative elements of using an ERAS protocol for RC.

Biochemical recurrence after robot-assisted extended pelvic lymphadenectomy for prostate cancer.

INTRODUCTION: Extended lymph node dissection (ELND) compared to limited lymph node dissection (LLND) at time of prostatectomy improves staging and lymph node (LN) yield. The effect on biochemical recurrence (BCR) and survival is less well understood. We sought to evaluate the benefit of robotic ELND and LLND with respect to BCR. MATERIALS AND METHODS: Between 2008-2012, 584 consecutive men with intermediate or high risk clinically localized adenocarcinoma of the prostate underwent robotic assisted radical prostatectomy (RARP) with concomitant LLND (n = 326) or ELND (n = 258). Survival estimates were made using the Kaplan-Meier method. Log-rank statistic was used for comparison of curves. BCR predictors were determined with multivariable Cox regression analysis. Chi-square and Wilcoxon rank-sum tests were used to compare discrete and continuous variables, respectively, across the two groups. RESULTS: Median follow up for ELND and LLND patients was 46 and 54 months, respectively. ELND yielded more LNs (20 versus 6, p < 0.0001) and had higher node positivity (15.1% versus 3.4%, p < 0.0001). BCR free survival (BCRFS) at 3 and 5 years for ELND and LLND was 85% and 75% (p = 0.01), and 76% and 67% (p = 0.10), respectively. In subgroup analysis, ELND was associated with higher 5 year BCRFS in node-negative patients (84% versus 68%, p = 0.0005) and in intermediate risk patients (93% versus 80%, p = 0.0002). In multivariable analysis, ELND was a significant predictor of BCRFS in node-negative (HR = 0.50, p = 0.003) and intermediate risk patients (HR = 0.54, p = 0.03). CONCLUSIONS: ELND improves LN yield and detection of positive nodes. BCR analysis suggests a reduced risk of PSA failure for robotic ELND in intermediate risk and node-negative patients.

Blunt Trauma Resulting in Testicular Evisceration: A Case Report.

Scrotal and testicular injuries are uncommon injuries, accounting for only a fraction of all trauma. Blunt scrotal trauma is accompanied by testicular rupture in up to 50% of cases. We present a rare case of scrotal rupture with evisceration of a viable, intact testicle after a motor vehicle accident. The patient's presentation, associated injuries, operation, and post-operative course are described. In brief, this is a case of a 69-year-old male who sustained multiple rib, pelvic, and right femur fractures in addition to scrotal injury after a motor vehicle accident. He was taken quickly to the operating room for the scrotal rupture, and his testicle was successfully replaced and scrotal laceration repaired. He did well post-operatively. This case represents one of the few accounts of this particular injury in the literature.

Readmission and complications after robotic surgery: experience of 10,000 operations at a comprehensive cancer center.

Evaluation of safety is of paramount importance with adoption of novel surgical technology. Although robotic surgery has become widely used in oncologic surgery, analysis of safety is lacking in comparison to traditional techniques. Standardized assessment of robotic surgical outcomes and adverse events following oncologic surgery is necessary for quality improvement with innovative technology. Between 2003 and 2016, 10,013 unique robotic operations were performed in 9,858 patients. Our prospectively maintained database was retrospectively reviewed for hospital readmissions and Clavien-Dindo grade ≥ 2 complications within 30 days. Multivariable logistic regression was used to identify predictors of surgical complications and hospital readmissions. Cases were stratified by discipline: genitourinary (n = 8240), gynecologic (n = 857), thoracic (n = 457), gastrointestinal (n = 322), hepatobiliary (n = 60), ear/nose/throat (n = 44) and general (n = 33). Intraoperative complications occurred in 42 surgeries (0.4%). Postoperative complications occurred in 946 patients [9.4%, highest grade 2 (n = 574), 3 (n = 288), 4 (n = 72), 5 (n = 10)]. Most frequent complications were ileus (154, 16.3%), anemia (91, 9.6%), cardiac arrhythmia (62, 6.6%), deep vein thrombosis/pulmonary embolus (47, 5.0%), wound infection (45, 4.8%) and urinary leak (43, 4.5%). 405 patients (4.0%) required readmission. Most common causes for hospital readmission were ileus (44, 10.9%), urinary leak (23, 5.7%), urinary tract infection (23, 5.7%), intra-abdominal abscess/fluid collection (23, 5.7%), and small bowel obstruction (19, 4.7%). On multivariable analysis, longer operative time and older age predicted complications and readmissions (p ≤ 0.02). Robotic-assisted surgery appears a safe for oncologic surgery with acceptable hospital readmission and complication rates. Older age and longer operative time were associated with complications and readmission.

Real-time indocyanine green angiography with the SPY fluorescence imaging platform decreases benign ureteroenteric strictures in urinary diversions performed during radical cystectomy.

BACKGROUND: Ischemia is thought to contribute to benign ureteroenteric stricture (UES) after radical cystectomy with urinary diversion (RCUD). Our institution adopted the use of ureteral perfusion assessment during all RCUDs using real-time indocyanine green angiography using the SPY fluorescence imaging platform (Stryker Corp., Kalamazoo, MI, USA). This guides the location of ureteral transection prior to ureteroenteric anastomosis. We sought to compare UES rates before and after adoption of SPY. METHODS: A retrospective chart review was undertaken for the first 47 consecutive cases of RCUD using SPY as well as the previous 47 consecutive cases, which were performed without SPY. Fisher's exact and Wilcoxon rank-sum tests were used to compare benign UES rates and the length of ureter excised during anastomosis. A p < 0.05 indicated statistical significance. RESULTS: Median follow up was 12.0 months for SPY cases and 24.3 months for non-SPY cases. The UES rate for SPY RCUDs was 0% (0/93 ureters) compared with 7.5% (7/93 ureters) for non-SPY RCUDs (p = 0.01). Amongst SPY RCUDs, 86 ureters had no hydronephrosis and 7 had mild hydronephrosis with reflux on loopogram. A total of 34.4% of ureters (32/93) had poor distal perfusion, requiring a more proximal anastomosis. The median length excised for ureters with poor distal perfusion was 3.8 cm, compared with 2.2 cm for ureters with good distal perfusion (p < 0.0001). No complications attributable to the use of SPY were noted. CONCLUSION: Use of SPY to assess ureteral perfusion was associated with a decrease in the UES rate after RCUD. A total of 34.4% of ureters demonstrated poor distal perfusion, requiring a significantly more proximal ureteroenteric anastomosis.

Lymph node-positive prostate cancer after robotic prostatectomy and extended pelvic lymphadenectomy.

Optimal management of node-positive prostate cancer patients after prostatectomy remains a challenge. We evaluated clinically localized patients who demonstrated node positivity and identified predictors for secondary treatment. From 2010 to 2015, clinically localized prostate cancer patients who underwent robot prostatectomy with extended lymphadenectomy and node-positive disease on pathologic analysis were identified. Clinical N1, M1 or salvage cases were excluded. Patients were stratified based on secondary treatments. Kaplan-Meier method was used to determine the time to biochemical and metastatic recurrence. Multivariate logistic regression was used to identify predictors for additional treatment. 145 patients (45 no additional therapy, 47 adjuvant, 53 salvage) had a median follow-up of 31.2 months. Salvage patients had higher median pre-operative prostate-specific antigen (10.8 vs. 9.7 vs. 8.2, p = 0.1), higher percentage of pathologic Gleason ≥8 (50.9 vs. 38.3% and 22.2%, p < 0.01), and higher median-positive nodes (3 vs. 1 and 1, p < 0.0001) compared to adjuvant and no treatment groups, respectively. Pathologic Gleason ≥8 (OR = 3.5, p = 0.007) and positive nodes ≥2 (OR = 3.3, p = 0.006) were associated with additional therapy. In the no treatment group, two-year estimated BCRFS was 74.3%. Two-year metastatic recurrence-free rates for no treatment, adjuvant and salvage groups were 100, 87.5, and 80.9%, respectively (p = 0.01). Observation is a viable alternative for low metastatic burden patients. In the largest series of node-positive patients from robotic prostatectomy and extended lymphadenectomy, those with pathologic Gleason ≥8 and positive lymph nodes ≥2 were more likely to receive additional treatment.