NeuroSAFE robot-assisted laparoscopic prostatectomy versus standard robot-assisted laparoscopic prostatectomy for men with localised prostate cancer (NeuroSAFE PROOF): protocol for a randomised controlled feasibility study.

INTRODUCTION: Robot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP. METHODS: NeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life. ETHICS AND DISSEMINATION: NeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03317990.

Retroperitoneal anomalies in men with testicular germ cell tumours.

OBJECTIVES: To assess whether vascular and other retroperitoneal anomalies are more frequent during retroperitoneal lymph node dissection (RPLND) for metastatic testicular tumours (when retroperitoneal masses persist after chemotherapy) than would be expected, based on the initial observations from one centre with a large experience of RPLND in the UK. PATIENTS AND METHODS: A prospective series of 278 consecutive patients treated with RPLND for testicular tumours comprised the sample population. For each patient the presence or absence of four factors from the history was recorded. Each patient then underwent RPLND. During surgery, a template was constructed of the anatomy of the retroperitoneum and the information stored. Eight different retroperitoneal anatomical anomalies were identified in the sample population; the incidence of each was then compared with the largest available study of a normal population, and differences analysed statistically. RESULTS: Of the 278 patients who had RPLND, 55 had 59 anomalies (21%), found by history and as retroperitoneal vascular and urological anomalies; cryptorchidism was present in 7.6%, 9.5 times the incidence in the control population (P < 0.01). A left-sided inferior vena cava was present in 3.6% of patients, 21 times the incidence in the control population (P < 0.001); a retro-aortic left renal vein in 3.2%, four times that in the control population (P < 0.05); and ipsilateral renal agenesis had an incidence of 1% in the test population, 11 times greater than in the control population (P < 0.01). CONCLUSIONS: This prospective study of 278 RPLNDs provides evidence that some retroperitoneal anatomical anomalies are associated with testicular germ cell tumours. The link between maldescent and testicular tumours, rather than an isolated association, should be considered as part of a spectrum of retroperitoneal anomalies that occur in these men.

First clinical experience with new transurethral bipolar prostate electrosurgery resection system: controlled tissue ablation (coblation technology).

BACKGROUND AND PURPOSE: Bipolar transurethral resection of the prostate (TURP) can allow transurethral debulking of the adenoma with a lower potential for complications from systemic absorption of hypotonic irrigant. We evaluated a new bipolar double-loop resection system with a dedicated controlled ablation (Coblation) generator in this context. PATIENTS AND METHODS: In our series of 36 patients, 32 underwent transurethral bipolar loop resection, of whom 12 had prostates >50 cc (range for entire series 30-126 cc) on transrectal ultrasonography. Ten men had indwelling catheters because of urinary retention. The four other patients underwent transurethral resection of bladder tumors. After an initial learning curve of eight TURPs, some minor technical modifications were made, both to the bipolar-loop resection technique and to the hardware. The modified Vista Coblation system was subsequently evaluated by 18 other urologists in 17 other centers throughout the U.S. RESULTS: The median resected dry weight was 22 g, and the median operating-room time was 48 minutes, giving a median resection rate of approximately 1 g every 2 minutes. Two of the eight men in our learning curve required treatment for delayed bleeding problems (clot obstruction of catheter), and one of these received a blood transfusion. Transfusion was not required subsequently regardless of prostate size, even in men with larger glands. One of the patients treated for bladder tumor had a minor perforation of the posterior bladder wall, which healed with conservative management. In the multicenter experience in the U.S., there were 59 evaluable patients. The median resected weight was 23 g, and the median resection time was 55 minutes. Two men required conversion to monopolar roller coagulation for intraoperative bleeding. Most patients (80%) were discharged from hospital within 24 hours. No adverse neuromuscular stimulation occurred. CONCLUSION: This first single-center and international multicenter experience with Coblation technology for bipolar double-loop saline TURP confirms the feasibility and safety of this procedure. Subjective evaluation showed the four most important perceived benefits of bipolar over monopolar TURP to be smoother cutting action, elimination of TUR syndrome, less tissue burning (and no smell), and reduced bleeding. The results of randomized studies with this technology are awaited, while its role in bladder tumor resection remains unclear.