Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Dinneen E

PROVIDER: S-EPMC6575674 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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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.

Dinneen Eoin E Haider Aiman A Allen Clare C Freeman Alex A Briggs Tim T Nathan Senthil S Brew-Graves Chris C Grierson Jack J Williams Norman R NR Persad Raj R Oakley Neil N Adshead Jim M JM Huland Hartwig H Haese Alexander A Shaw Greg G

BMJ open 20190611 6

<h4>Introduction</h4>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 ...[more]

PMID: 31189680

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Project description:IntroductiondHACM is a source of factors including cytokines that allow anti-inflammatory and proliferative elements to be utilized for wound and ulcer management. We present our experience of using dHACM in a cohort of patients undergoing nerve-sparing (NS) robot-assisted laparoscopic prostatectomy (RALP). Our objective is to investigate the functional and oncological outcomes of NS after placing amniotic or dehydrated human amnion/chorion membrane (dHACM) on preserved neurovascular bundles (NVBs). From 2013 to 2019, our institution performed transperitoneal multi-port da Vinci robotic prostatectomy. The NVBs are spared by releasing their fascial planes posteriorly, followed by an anterior release of the plane at a similar level. Once the retrograde release of the NVB is performed then 599 patients underwent placement of dHACM graft (AmnioFix by MiMedx, Marietta, GA, USA). The graft was cut into two 4 × 1 cm pieces and laid over the NVB as a wrap. In order to inform the urological community of oncological and functional outcomes, we excluded patients with less than 12 months follow up (n = 64), benign prostatic hyperplasia (n = 5), and unilateral NS (n = 1). 529 (88%) patients were included in this study who underwent a partial or full bilateral NS with dHACM. 529 patients were followed-up for a median (IQR) of 42 months (25-89). Demographics include median (IQR) age 57 years (52-62), median preoperative SHIM score of 24 (21-15), and AUASS of 5 (2-11). Full NS was performed in 74% (391/529). Pathological staging was pT2 = 399 (75%), pT3a = 107 (20%), pT3b = 19 (4%) and pT4 = 4 (1%) with N1 = 3 (0.6%). The number of patients with PSM was 86 (16%), and the overall BCR in the entire cohort was 10%. Postoperatively, 434 (82%) were sexually active. Median time to potency was 119 (37-420) days and time to continence was 42 (23-91) days. Regarding full vs partial NS: median post op SHIM score 18 (13-20) vs 15 (6-20), median time to potency 92 (35-365) days vs 184 (42-560) days, and median time to continence 42 (23-91) days vs 44 (30-92) days. Age > 55 vs ≤ 55 years: median post op SHIM score 18 (12-20) vs 15 (10-20), median time to potency 167 days (42-549) vs 80 (35-288) days, and median time to continence 42 (25-116) days vs 42 (29-76) days. In our series the application of amniotic membrane/dHACM has led to acceptable post RALP outcomes. The BCR rate of 10% in addition to the recovery of potency at a median time of 3 months and continence at 6 weeks is an encouraging result of dHACM. Our findings indicate that dHACM allowed for an even faster period for continence recovery which was independent of grade of NS. Future comparative studies may further assess the impact of new amniotic membrane types on the functional and oncological outcomes after RALP.

Project description:BackgroundRobotic radical prostatectomy (RARP) is a first-line curative treatment option for localized prostate cancer. Postoperative erectile dysfunction and urinary incontinence are common associated adverse side effects that can negatively impact patients' quality of life. Preserving the lateral neurovascular bundles (NS) during RARP improves functional outcomes. However, selecting men for NS may be difficult when there is concern about incurring in positive surgical margin (PSM) which in turn risks adverse oncological outcomes. The NeuroSAFE technique (intra-operative frozen section examination of the neurovascular structure adjacent prostate margin) can provide real-time pathological consult to promote optimal NS whilst avoiding PSM.MethodsNeuroSAFE PROOF is a single-blinded, multi-centre, randomised controlled trial (RCT) in which men are randomly allocated 1:1 to either NeuroSAFE RARP or standard RARP. Men electing for RARP as primary treatment, who are continent and have good baseline erectile function (EF), defined by International Index of Erectile Function (IIEF-5) score > 21, are eligible. NS in the intervention arm is guided by the NeuroSAFE technique. NS in the standard arm is based on standard of care, i.e. a pre-operative image-based planning meeting, patient-specific clinical information, and digital rectal examination. The primary outcome is assessment of EF at 12 months. The primary endpoint is the proportion of men who achieve IIEF-5 score ≥ 21. A sample size of 404 was calculated to give a power of 90% to detect a difference of 14% between groups based on a feasibility study. Oncological outcomes are continuously monitored by an independent Data Monitoring Committee. Key secondary outcomes include urinary continence at 3 months assessed by the international consultation on incontinence questionnaire, rate of biochemical recurrence, EF recovery at 24 months, and difference in quality of life.DiscussionNeuroSAFE PROOF is the first RCT of intra-operative frozen section during radical prostatectomy in the world. It is properly powered to evaluate a difference in the recovery of EF for men undergoing RARP assessed by patient-reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.Trial registrationNCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.

Project description:Take Home Message Our review revealed a significantly higher annual volume of surgery per surgeon (AVSS), a higher percentage of low-risk patients, and lower rates of lymphadenectomy and complications for robot-assisted radical prostatectomy (RARP) compared to open and laparoscopic techniques. RARP showed better performance for all the perioperative variables studied except for operative time. Among all the outcomes, only AVSS was significantly correlated with complication rates. The AVSS required to achieve a target complication rate was significantly lower for RARP. Context The advantages of minimally invasive surgery for radical prostatectomy (RP) have been demonstrated in a number of systematic reviews (SRs). However, the rigorous study selection process for SR means that a lot of information can be excluded, leading to a very specific clinical scenario that is often unrepresentative of real life. Our new reverse SR methodology generates a heterogeneous population database that covers a wide range of clinical scenarios. Objective To compare perioperative surgical results and complications for open retropubic RP (RRP), laparoscopic RP (LRP), and robot-assisted RP (RARP) in a reverse SR. Evidence acquisition Eight databases were searched for SRs on RRP, LRP, or RARP between 2000 and 2020 (80 SRs). All references used in these SRs were captured for analysis (1724 articles). Perioperative outcomes and complications were compared among the RRP, LRP, and RARP approaches. Evidence synthesis We identified 559 (32.4%) reports on RRP, 413 (23.9%) on LRP, and 752 (43.7%) on RARP, involving 1 353 485 patients overall. RARP showed a significantly higher annual volume of surgery per surgeon (AVSS) in comparison to RRP and LRP (mean 64.29, 43.26, and 41.47, respectively), a higher percentage of low-risk patients (prostate-specific antigen <10 ng/ml, Gleason <7, stage <cT2), and a lower rate of lymphadenectomy, culminating in a lower complication rate (12.3% for RARP, 16.3% for LRP, 20.2% for RRP). Among all outcomes, only AVSS was significantly correlated with complication rates. An AVSS of 30, 95 and 95 surgeries/yr was required for RARP, LRP, and RRP, respectively, to obtain a complication rate of 12.3% (average for RARP). RARP showed better performance for all perioperative variables studied except for operative time (operative time: 199.8 vs 214.9 vs 169.5 min; estimated blood loss: 228.2 vs 408.0 vs 852.1 ml; blood transfusion rate: 2.8% vs 6.5% vs 19.8%; length of stay: 2.9 vs 5.7 vs 6.1 d; catheter time: 7.8 vs 8.5 vs 11.0 d for RARP vs LRP vs RRP). Conclusions Our reverse SR involved a wide real-life representative sample and reference values established in the literature and revealed that minimally invasive surgery had the best perioperative and complication results, especially RARP, which was associated with less complex cases, higher annual surgeon volume, and greater performance. Patient summary We used a wide sample representative of real-life surgical practice and reference values established in the literature for three techniques for removal of the prostate to guide patients and physicians in deciding the best surgical treatment for prostate cancer according to availability.

Dataset Information

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.

Publications

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.

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