scholarly journals INTRAOPERATIVE HISTOLOGICAL FROZEN-SECTION EXAMINATION OF PROSTATE REGIONS ADJACENT TO NEUROVASCULAR BUNDLE: INITIAL IMPLEMENTATION EXPERIENCE DURING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY

2019 ◽  
pp. 66-71 ◽  
Author(s):  
EGOR A. SOKOLOV ◽  
◽  
EVGENY I. VELIEV ◽  
OXANA V. PAKLINA ◽  
GRIGORY V. KNYSHINSKY ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Frozen Section ◽  
Neurovascular Bundle ◽  
Robotic Assisted ◽  
Frozen Section Examination ◽  
Initial Implementation ◽  
Robotic Assisted Radical Prostatectomy ◽  
Implementation Experience

A feasible and time-efficient adaption of the neurosafe intraoperative frozen section technique to robotic-assisted radical prostatectomy.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 147-147
Author(s):  
Burkhard Beyer ◽  
Pierre Tennstedt ◽  
Katharina Boehm ◽  
Jonas Schiffmann ◽  
Thorsten Schlomm ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Blood Loss ◽  
Frozen Section ◽  
Oncological Outcome ◽  
Nerve Sparing ◽  
Frozen Sections ◽  
Robotic Assisted ◽  
Significant Difference ◽  
Robotic Assisted Radical Prostatectomy ◽  
Patient Side

147 Background: In robotic-assisted radical prostatectomy (RARP) intraoperative frozen sections are often avoided due to suspected difficulties in harvesting the prostate during this procedure, loss in pneumoperitoneum, increased blood loss and lacking impact on functional outcome. We demonstrate the technique, feasibility and beneficial impact of our NeuroSAFE technique on the rate of nerve-sparing (NS) in RARP and analyse the oncological outcome. Methods: We analyzed 1,570 consecutive patients undergoing RARP from 2004 to 2012. NeuroSAFE was done in 1,178 pts. We compared OR-time, blood loss, frequency of nerve-sparing (NS) and PSM in non-NeuroSAFE versus NeuroSAFE-RARP. The prostate was intraoperatively harvested via an extension of the camera trocar incision without undocking the system. Instrument arms were not undocked. Blood spillage from the dorsal vein complex due to loss of pneumoperitoneum was avoided by upward traction on the transurethral catheter. After prostate removal, pneumoperitoneum was reestablished by closing the extended incision and repositioning of the optical trocar. NeuroSAFE-procedure consisted of intraoperative bilateral frozen sections covering the entire contact area of the prostate and the neurovascular bundles. Results: There was no significant difference in blood loss (253.5±204.4 ml vs. 265.8±246.7 ml, p=0.49) and OR-time. (220 min ± 51 vs. 224 min ± 64, p=0.22). No complications associated with specimen harvesting occurred. NS-rate increased significantly with vs. without NeuroSAFE (overall 97% vs. 81%, pT2 99% vs. 90%, pT3a 94% vs. 74%, pT3b 91% vs. 30). PSM rate dropped significantly with NeuroSAFE (overall 16% vs. 24%, pT2 8% vs. 15%, pT3a 22% vs. 39%, pT3b 49% vs. 67%, all p<0.05). Conclusions: We demonstrate a time-efficient adaption of the NeuroSAFE without patient side cart undocking, easy harvesting process, no increased blood loss or OR-time increased rate of nerve-sparing frequency and reduction of PSMs.

A single-blinded, multicenter, randomized controlled trial to evaluate NeuroSAFE robotic-assisted radical prostatectomy (RARP) versus standard robotic-assisted radical prostatectomy (RARP) in men with localized prostate cancer: NeuroSAFE PROOF—Trial in progress.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. TPS262-TPS262
Author(s):  
Eoin Dinneen ◽  
Jack Grierson ◽  
Aiman Haider ◽  
Alex Freeman ◽  
Jonathan Aning ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Frozen Section ◽  
Controlled Trial ◽  
Urinary Continence ◽  
Robotic Assisted ◽  
Oncological Safety ◽  
Robotic Assisted Radical Prostatectomy ◽  
Randomised Controlled

TPS262 Background: Robot-assisted radical prostatectomy (RARP) offers cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are preserved during a nerve-sparing (NS) RARP. The NeuroSAFE (intra-operative frozen section examination of the neurovascular structure adjacent prostate margin) seeks to promote optimal NS to maximise the opportunity for functional recovery without jeopardising oncological safety. The NeuroSAFE technique in RP has never been evaluated against a standard of care in an randomised controlled trial. Methods: This is a pragmatic, multicentre, single-blinded randomised controlled trial (RCT) in which men are allocated in a 1:1 ratio to NeuroSAFE RARP or standard RARP. Men in the NeuroSAFE RARP arm will undergo RARP with NS guided by the NeuroSAFE technique. Men in the standard RARP arm will undergo RARP with NS guided by standard current practice (prostate cancer clinical characteristics, multi-parametric magnetic resonance imaging (mpMRI) recommendations and digital rectal examination (DRE)). Eligible men will have operable localised prostate cancer, will be opting for RARP as primary treatment and will have good baseline erectile function (EF) (as defined by an Internatinoal Index of Erectile Function (IIEF)-5 score >21). The primary outcome is the proportion of men who achieve EF recovery at 12-months according to the IIEF. Oncological safety will be ensured by the independent DMC who will routinely review proportions of men with treatment failure (adjuvant therapy or biochemical recurrence (BCR)) in each arm. A sample size of 404 is estimated required. NeuroSAFE PROOF will continue to follow participant recovery for 5 years following treatment. Key secondary outcomes include patient-reported urinary continence recovery, sexual satisfaction, quality of life, and economic analyses. NeuroSAFE PROOF will be the first RCT of frozen section in radical prostatectomy (RP) in the world. Ethics and dissemination: Ethical approval was obtained from the National Research Ethics Committee North London (17/LO/1978). Results of this study will be disseminated through national and international papers, and to study participants. Clinical trial information: NCT03317990.

NeuroSAFE PROOF: study protocol for a single-blinded, IDEAL stage 3, multi-centre, randomised controlled trial of NeuroSAFE robotic-assisted radical prostatectomy versus standard robotic-assisted radical prostatectomy in men with localized prostate cancer.

2022 ◽  
Author(s):  
Eoin Dinneen ◽  
Jack Grierson ◽  
Ricardo Almeida Magana ◽  
Rosie Clow ◽  
Aiman Haider ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radical Prostatectomy ◽  
Frozen Section ◽  
Controlled Trial ◽  
Robotic Assisted ◽  
Oncological Outcomes ◽  
The World ◽  
Robotic Assisted Radical Prostatectomy ◽  
Randomised Controlled

Abstract 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 while 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.DiscussionThe NeuroSAFE PROOF is the first RCT of intra-operative frozen section in 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 registration: NCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.

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