Level 1 Evidence of Better Early Urinary Continence at 3 Months Following Robot-assisted Laparoscopic Radical Prostatectomy Compared with Laparoscopic Radical Prostatectomy. Results of the LAP-01 Randomised Controlled Trial

2021 ◽  
Author(s):  
John W. Yaxley ◽  
Geoff Coughlin ◽  
Vipul Patel
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Controlled Trial ◽  
Laparoscopic Radical Prostatectomy ◽  
Urinary Continence ◽  
Robot Assisted ◽  
Level 1 ◽  
Randomised Controlled

scholarly journals Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial

2021 ◽  
Author(s):  
Ruth E. Ashton ◽  
Jonathan J. Aning ◽  
Garry A. Tew ◽  
Wendy A Robson ◽  
John M Saxton
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Muscular Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Robot Assisted ◽  
Resistance Exercise Training ◽  
Home Based ◽  
Aerobic Exercise Capacity ◽  
Randomised Controlled

Abstract Purpose To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP). Methods This study was a single-site, two-arm randomised controlled trial, with 40 participants randomised to either the intervention or control group over a 10-month period. In addition to receiving usual care, the intervention group completed three weekly RET sessions using resistance bands for 6 months. Participants performed 3 sets of 12–15 repetitions for each exercise, targeting each major muscle group. The control group received usual care only. Brachial artery flow-mediated dilatation (FMD) was the primary outcome and assessed at baseline, 3 and 6 months. Secondary outcomes included body weight, body fat, aerobic fitness, strength and blood-borne biomarkers associated with cardiometabolic risk. Results There was no significant difference between the groups in FMD at 3 or 6 months. However, there were improvements in aerobic exercise capacity (P < 0.01) and upper- (P < 0.01) and lower-limb (P = 0.01) strength in favour of the RET group at 6 months, accompanied by greater weight loss (P = 0.04) and a reduction in body fat (P = 0.02). Improvements in HRQoL were evident in the RET group at 3 and 6 months via the PCa-specific component of the FACT-P questionnaire (both P < 0.01). Five adverse events and one serious adverse event were reported throughout the trial duration. Conclusion This study demonstrates that home-based RET is an effective and safe mode of exercise that elicits beneficial effects on aerobic exercise capacity, muscular strength and HR-QoL in men who have undergone RARP. Trial registration ISRCTN10490647.

Randomised Controlled Trial Comparing Laparoscopic and Robot-assisted Radical Prostatectomy

2013 ◽  
Vol 63 (4) ◽  
pp. 606-614 ◽  
Author(s):  
Francesco Porpiglia ◽  
Ivano Morra ◽  
Marco Lucci Chiarissi ◽  
Matteo Manfredi ◽  
Fabrizio Mele ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Radical Prostatectomy ◽  
Controlled Trial ◽  
Robot Assisted ◽  
Randomised Controlled

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.

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