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      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

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          Abstract

          Background

          Robotic 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.

          Methods

          NeuroSAFE 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.

          Discussion

          NeuroSAFE 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 registration

          NCT03317990 (23 October 2017). Regional Ethics Committee; reference 17/LO/1978.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-06421-7.

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          Most cited references38

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          Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

          This article provides an update on the global cancer burden using the GLOBOCAN 2020 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer. Worldwide, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. Overall incidence was from 2-fold to 3-fold higher in transitioned versus transitioning countries for both sexes, whereas mortality varied <2-fold for men and little for women. Death rates for female breast and cervical cancers, however, were considerably higher in transitioning versus transitioned countries (15.0 vs 12.8 per 100,000 and 12.4 vs 5.2 per 100,000, respectively). The global cancer burden is expected to be 28.4 million cases in 2040, a 47% rise from 2020, with a larger increase in transitioning (64% to 95%) versus transitioned (32% to 56%) countries due to demographic changes, although this may be further exacerbated by increasing risk factors associated with globalization and a growing economy. Efforts to build a sustainable infrastructure for the dissemination of cancer prevention measures and provision of cancer care in transitioning countries is critical for global cancer control.
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            Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

            Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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              The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction.

              To develop a brief, reliable, self-administered measure of erectile function that is cross-culturally valid and psychometrically sound, with the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. Relevant domains of sexual function across various cultures were identified via a literature search of existing questionnaires and interviews of male patients with erectile dysfunction and of their partners. An initial questionnaire was administered to patients with erectile dysfunction, with results reviewed by an international panel of experts. Following linguistic validation in 10 languages, the final 15-item questionnaire, the international index of Erectile Function (IIEF), was examined for sensitivity, specificity, reliability (internal consistency and test-retest repeatability), and construct (concurrent, convergent, and discriminant) validity. A principal components analysis identified five factors (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) with eigenvalues greater than 1.0. A high degree of internal consistency was observed for each of the five domains and for the total scale (Cronbach's alpha values of 0.73 and higher and 0.91 and higher, respectively) in the populations studied. Test-retest repeatability correlation coefficients for the five domain scores were highly significant. The IIEF demonstrated adequate construct validity, and all five domains showed a high degree of sensitivity and specificity to the effects of treatment. Significant (P values = 0.0001) changes between baseline and post-treatment scores were observed across all five domains in the treatment responder cohort, but not in the treatment nonresponder cohort. The IIEF addresses the relevant domains of male sexual function (that is, erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), is psychometrically sound, and has been linguistically validated in 10 languages. This questionnaire is readily self-administered in research or clinical settings. The IIEF demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction.
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                Author and article information

                Contributors
                eoin.dinneen@nhs.net
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                22 July 2022
                22 July 2022
                2022
                : 23
                : 584
                Affiliations
                [1 ]GRID grid.83440.3b, ISNI 0000000121901201, Division of Surgery & Interventional Science, , University College London, ; London, UK
                [2 ]GRID grid.439749.4, ISNI 0000 0004 0612 2754, University College Hospital London, Department of Urology, Westmoreland Street Hospital, ; 6-18 Westmoreland Street, W1G 8PH London, UK
                [3 ]GRID grid.5337.2, ISNI 0000 0004 1936 7603, University College Hospital London, Department of Histopathology, ; 235 Euston Road, Bristol, NW1 2BU UK
                [4 ]GRID grid.83440.3b, ISNI 0000000121901201, Division of Medicine, , University College London, ; Charles Bell House, 43-45 Foley Street, Sheffield, W1W 7JN UK
                [5 ]GRID grid.83440.3b, ISNI 0000000121901201, Department of Applied Health Research, , University College London, ; 1-19 Torrington Place, Glasgow, WC1E 7HB UK
                [6 ]GRID grid.416201.0, ISNI 0000 0004 0417 1173, North Bristol Hospitals Trust, Department of Urology, Southmead Hospital, Southmead Lane, Westbury-on-Trym, ; Bristol, BS10 5NB UK
                [7 ]GRID grid.416201.0, ISNI 0000 0004 0417 1173, North Bristol Hospitals Trust, Department of Histopathology, Southmead Hospital, Southmead Lane, Westbury-on-Trym, ; BS10 5NB Bristol, UK
                [8 ]GRID grid.416126.6, ISNI 0000 0004 0641 6031, Sheffield Teaching Hospitals NHS Trust, Department of Urology, Royal Hallamshire Hospital, ; Glossop Road, S10 2JF UK
                [9 ]GRID grid.416126.6, ISNI 0000 0004 0641 6031, Sheffield Teaching Hospitals NHS Trust, Department of Histopathology, Royal Hallamshire Hospital, ; Glossop Road, S10 2JF UK
                [10 ]Glasgow & Clyde NHS Trust, Department of Urology, Queen Elizabeth Hospital, 1345 Govan Road, Glasgow, UK
                [11 ]Glasgow & Clude NHS Trust, Department of Histopathology, Queen Elizabeth Hospital, 1345 Govan Road, Glasgow, UK
                [12 ]Barking Havering & Redbridge University Hospitals Trust, Rom Valley Way, Romford, RM7 0AG UK
                Author information
                http://orcid.org/0000-0002-4309-3257
                Article
                6421
                10.1186/s13063-022-06421-7
                9306247
                35869497
                ae8974ef-7ad7-4624-88f9-9c229c04e120
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 14 April 2022
                : 24 May 2022
                Funding
                Funded by: The Jon Moulton Charity Trust
                Award ID: n/a
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Medicine
                neurosafe,nerve sparing,frozen section,potency,robotic prostatectomy,prostate cancer,randomised controlled trial,protocol

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