scholarly journals 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

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028132 ◽  
Author(s):  
Eoin Dinneen ◽  
Aiman Haider ◽  
Clare Allen ◽  
Alex Freeman ◽  
Tim Briggs ◽  
...  

IntroductionRobot-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.MethodsNeuroSAFE 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 disseminationNeuroSAFE 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 numberNCT03317990.

ISRN Oncology ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Michael Musch ◽  
Ulla Roggenbuck ◽  
Virgilijus Klevecka ◽  
Heinrich Loewen ◽  
Maxim Janowski ◽  
...  

We assessed whether changeover from open retropubic [RRP] to robotic-assisted laparoscopic prostatectomy [RALP] means a step forward or backward for the initial RALP patients. Therefore the first 105 RALPs of an experienced open prostatic surgeon and robotic novice—with tutoring in the initial 25 cases—were compared to the most recent 105 RRPs of the same surgeon. The groups were comparable with respect to patient characteristics and postoperative tumor characteristics (all P>0.09). The only disadvantage of RALP was a longer operating time; the advantages were lower estimated blood loss, fewer anastomotic leakages, earlier catheter removal, shorter hospital stay (all P<0.04), and less major complications within 90 days postoperatively (P<0.01). Positive surgical margin rates were comparable both overall and stratified for pT stage in both groups (all P<0.08). In addition, an equivalent number of lymph nodes were removed (P>0.07). Twelve months after surgery, patient reported continence and erectile function were comparably good (all P>0.11). Our study indicates that an experienced open prostatic surgeon and robotic novice who switches to RALP can achieve favorable surgical results despite the initial RALP learning curve. At the same time neither oncological nor functional outcomes are compromised.


2014 ◽  
pp. 150127063130004 ◽  
Author(s):  
Andrew J. Lightfoot ◽  
Yu-Kai Su ◽  
Shailen Shivam Sehgal ◽  
Ziho Lee ◽  
Giovanni H. Greaves ◽  
...  

2014 ◽  
Vol 8 (5-6) ◽  
pp. 195 ◽  
Author(s):  
Kevin Christopher Zorn ◽  
Côme Tholomier ◽  
Marc Bienz ◽  
Pierre-Alain Hueber ◽  
Quoc Dien Trinh ◽  
...  

Introduction: While RARP (robotic-assisted radical prostatectomy) has become the predominant surgical approach to treat localized prostate cancer, there is little Canadian data on its oncological and functional outcomes. We describe the largest RARP experience in Canada.Methods: Data from 722 patients who underwent RARP performed by 7 surgeons (AEH performed 288, TH 69, JBL 23, SB 17, HW 15, QT 7, and KCZ 303 patients) were collected prospectively from October 2006 to December 2013. Preoperative characteristics, as well as postoperative surgical and pathological outcomes, were collected. Functional and oncological outcomes were also assessed up to 72 months postoperative.Results: The median follow-up (Q1-Q3) was 18 months (9-36). The D’Amico risk stratification distribution was 31% low, 58% intermediate and 11% high-risk. The median operative time was 178 minutes (142-205), blood loss was 200 mL (150-300) and the postoperative hospital stay was 1 day (1-23). The transfusion rate was only 1.0%. There were 0.7% major (Clavien III-IV) and 10.1% minor (Clavien I-II) postoperative complications, with no mortality. Pathologically, 445 men (70%) were stage pT2, of which 81 (18%) had a positive surgical margin (PSM). In addition, 189 patients (30%) were stage pT3 and 87 (46%) with PSM. Urinary continence (0-pads/day) returned at 3, 6, and 12 months for 68%, 80%, and 90% of patients, respectively. Overall, the potency rates (successful penetration) for all men at 6, 12, and 24 months were 37%, 52%, and 59%, respectively. Biochemical recurrence was observed in 28 patients (4.9%), and 14 patients (2.4%) were referred for early salvage radiotherapy. In total, 49 patients (8.4%) underwent radiotherapy and/or hormonal therapy.Conclusions: This study shows similar results compared to other high-volume RARP programs. Being the largest RARP experience in Canada, we report that RARP is safe with acceptable oncologic outcomes in a Canadian setting.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5580-5580
Author(s):  
Shifeng Mao ◽  
Ralph Miller ◽  
John Lyne ◽  
Jeffrey Cohen ◽  
Arash Samiei

5580 Background: Obesity and metabolic syndrome (MS) is prevalent in our society, and have been linked to a higher incidence of prostate cancer (PCa). The relationship of obesity or MS and cancer control has yielded mixed results in previous studies. We examined the correlation between the incidence of biochemical recurrence (BCR) with MS and BMI in a cohort of patients with PCa who underwent robotic-assisted laparoscopic prostatectomy (RALP). Methods: A retrospective study of patients who underwent RALP at a single center from 2007 to 2015 was conducted. Parameters including preoperative BMI, fasting glucose, lipid profile, blood pressure, PSA, Gleason score, pathologic stage, time to BCR, and surgical margin status were analyzed. Patients were categorized in high (HR), intermediate (IR), and low-risk (LR) groups based on the National Comprehensive Cancer Network (NCCN) guidelines. WHO classification was used for MS criteria, and BCR was defined as two consecutive postoperative PSA volume of ≥ 0.2 ng/mL. Obesity is defined as BMI ≥30 kg/m2. Results: A total of 726 patients with 189 in HR, 471 in IR and 66 patients in LR groups were included in this study with the median age of 59 (interquartile range [IQR] 55-64) years old. The median follow-up from surgery was 38 (IQR 22-46) months. More obese patients were found in the HR group compared to IR/LR group (46.5% vs. 33.1%, p<0.01). There were also more patients with MS in the HR group compared to IR/LR group (36.5% vs. 12.0%, p<0.01). Obese patients had a higher rate of BCR across risk groups in comparison to non-obese patients 32.1% vs. 15.4% (P<0.001), specifically 68% vs. 40%(p<0.01) in HR group and 21.3% vs. 12.7% (p=0.035) in the IR group. Similarly, patients with MS had a higher rate of BCR in HR and IR groups in comparison to the patients without MS, 39.1% vs. 18.7% (P<0.01); specifically, 67.7% vs. 42.2% (p<0.01) in HR and 29% vs. 11.6% (p<0.01) in the IR group. No correlation between MS or obesity and BCR was observed in LR group. There was no statistically significant difference in the positive surgical margin rate between obese and non-obese cohorts in each risk group. Conclusions: Among HR and IR-PCa patietns who underwent RALP, both obesity and MS correlate with increased risk of BCR. There were significantly more obesity and MS in HR-PCa patients, suggesting a potential pathophysiologic interplay between obesity or MS and cancer progression.


2015 ◽  
Vol 29 (6) ◽  
pp. 634-639 ◽  
Author(s):  
Andrew J. Lightfoot ◽  
Yu-Kai Su ◽  
Shailen S. Sehgal ◽  
Ziho Lee ◽  
Giovanni H. Greaves ◽  
...  

2017 ◽  
Vol 11 (1) ◽  
pp. 15-20 ◽  
Author(s):  
Christopher G Eden ◽  
Dimitrios Moschonas ◽  
Ricardo Soares

Objective: The purpose of this study was to investigate urinary continence four weeks following Retzius-sparing robot-assisted radical prostatectomy. Patients and methods: Forty patients with T2–T3 prostate cancer underwent Retzius-sparing-robot-assisted radical prostatectomy and their results were compared with those from the 40 patients having robot-assisted radical prostatectomy done by the same surgeon immediately prior to the adoption of Retzius-sparing-robot-assisted radical prostatectomy. Results: Patients in the two groups had similar age, body mass index, prostate specific antigen, biopsy Gleason sum, clinical stage, d’Amico risk profile, blood loss, prostate weight and post-operative hospital stay. Median operating time (200 (interquartile range=155–266) vs 223 (interquartile range=100–238) min; p=0.05) and catheterisation (8 (interquartile range=8–8) vs 14 (interquartile range=14–14) days; p<0.0001) were shorter in the Retzius-sparing group, many of whom had suprapubic catheters inserted. The overall complication rate was lower in Retzius-sparing patients (2.5% vs 8.0%; p=0.36). Positive surgical margin rates were similar for Retzius-sparing and non-Retzius-sparing patients and decreased with greater experience with the Retzius-sparing technique: 16.7% vs 7.7% for pT2 ( p=0.65) and 31.8% vs 14.3% for pT3 ( p=0.44). Initial prostate specific antigen was <0.1 ng/ml in 97.5% and 100%, respectively ( p=1.00). At four weeks post-operation 0, 1 and 2 pads/day were needed in the Retzius-sparing group in 90.0%, 7.5% and 2.5% of patients, compared to 37.5% ( p<0.0001), 32.5% ( p=0.01) and 30% ( p=0.002) of men having conventional surgery. Conclusion: Retzius-sparing-robot-assisted radical prostatectomy is faster than the anterior approach to the prostate, allows a shorter catheterisation time and produces dramatically better continence results at four weeks with 90% of patients being pad-free and 97.5% of patients needing 0–1 pads/day.


2019 ◽  
Vol 8 (12) ◽  
pp. 2068 ◽  
Author(s):  
Jong Won Kim ◽  
Do Kyung Kim ◽  
Hyun Kyu Ahn ◽  
Hae Do Jung ◽  
Joo Yong Lee ◽  
...  

This study aimed to evaluate the effect of bladder neck preservation (BNP) on long-term urinary continence after robot-assisted laparoscopic prostatectomy (RALP). We systematically searched the PubMed, Embase, and Cochrane Library databases to identify studies that assessed the difference in urinary continence and oncologic outcomes between patients who underwent RALP with BNP and those who underwent RALP without BNP. Four trials (1880 cases with BNP, 727 controls without BNP) were considered suitable for meta-analysis. BNP was associated with significantly better urinary continence outcomes at 3–4 months (odds ratio (OR), 2.88; 95% confidence interval (CI), 1.52–5.48; p = 0.001), 12 months (OR, 2.03; 95% CI, 1.10–3.74; p = 0.02), and 24 months (OR, 3.23; 95% CI, 1.13–9.20; p = 0.03) after RALP. There was no difference in the rate of overall positive surgical margin (PSM) (OR, 1.00; 95% CI, 0.72–1.39; p = 0.99) and that of PSM at the prostate base (OR, 0.49; 95% CI, 0.21–1.13; p = 0.09) between the two groups. The BNP technique during RALP leads to early return of urinary continence and long-term urinary continence without compromising the oncologic outcomes.


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