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1.
Trials ; 25(1): 106, 2024 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-38310274

RESUMO

BACKGROUND: Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine. METHODS: This is a single-centre evaluator-blinded RCT with a 1:1 allocation ratio. Participants (n = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with grade A accuracy (Gertzbein-Robbins classification) on postoperative computed tomography images. The secondary outcomes are intervention time, operation room occupancy time, length of stay, estimated blood loss, surgeon's radiation exposure, screw fracture/loosening, superior-level facet joint violation, complication rate, reoperation rate on the same level or one level above, functional and clinical outcomes (Oswestry Disability Index, pain, Hospital Anxiety and Depression Scale, sensory and motor status) and cost-utility analysis. DISCUSSION: This RCT will provide insight into whether robot-assisted surgery with the newest generation spinal robot yields better pedicle screw placement accuracy than freehand surgery. Potential benefits of robot-assisted surgery include lower complication and revision rates, shorter length of stay, lower radiation exposure and reduction of economic cost of the overall care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05553028. Registered on September 23, 2022.


Assuntos
Parafusos Pediculares , Procedimentos Cirúrgicos Robóticos , Robótica , Fusão Vertebral , Cirurgia Assistida por Computador , Humanos , Parafusos Pediculares/efeitos adversos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Cirurgia Assistida por Computador/efeitos adversos , Fusão Vertebral/efeitos adversos , Fusão Vertebral/métodos , Estudos Retrospectivos , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto
2.
Bull Cancer ; 103(5): 461-8, 2016 May.
Artigo em Francês | MEDLINE | ID: mdl-26995400

RESUMO

OBJECTIVES: Radical prostatectomy (RP) remains a standard for localized prostate cancer treatment. The objective of this study is to present this operating technique of the robot-assisted radical prostatectomy (PR-RA) and to evaluate oncological and functional results as well as on the surgical safety. METHODS: A first series of 1679 patients consecutively operated in our institution with this technique from 2005 to 2010 and with a 5-year follow-up evaluated in 2014. The oncology monitoring is ensured with a PSA test every six months during the first three years and once a year the years after if the level remains undetectable. RESULTS: The oncologic outcomes show 17.4% for pT2 stages and 36.9% for pT3 stages positive margins. The level of biological recurrence is 21.27% with an average delay of 88 months as the time needed for the recurrence to occur. At 12 months, urinary continence (0-1pad/day) returned at 94% of all patients and potency with successful penetration for all men is 61.1% and 88.8% for men with sexual activity before surgery. CONCLUSIONS: The technique PRRA seems to be a reliable technique whose functional results studied from meta-analysis seem to be superior in terms of rapidity of recovery of the continence and erection in comparison with classical surgical or laparoscopic approach.


Assuntos
Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Disfunção Erétil/etiologia , Humanos , Masculino , Margens de Excisão , Pessoa de Meia-Idade , Recidiva Local de Neoplasia , Ereção Peniana , Complicações Pós-Operatórias , Antígeno Prostático Específico/sangue , Prostatectomia/efeitos adversos , Prostatectomia/instrumentação , Neoplasias da Próstata/sangue , Neoplasias da Próstata/patologia , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/instrumentação , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária/etiologia
3.
BJU Int ; 116(1): 93-101, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25359658

RESUMO

OBJECTIVES: To explore the views of experts about the development and validation of a robotic surgery training curriculum, and how this should be implemented. MATERIALS AND METHODS: An international expert panel was invited to a structured session for discussion. The study was of a mixed design, including qualitative and quantitative components based on focus group interviews during the European Association of Urology (EAU) Robotic Urology Section (ERUS) (2012), EAU (2013) and ERUS (2013) meetings. After introduction to the aims, principles and current status of the curriculum development, group responses were elicited. After content analysis of recorded interviews generated themes were discussed at the second meeting, where consensus was achieved on each theme. This discussion also underwent content analysis, and was used to draft a curriculum proposal. At the third meeting, a quantitative questionnaire about this curriculum was disseminated to attendees to assess the level of agreement with the key points. RESULTS: In all, 150 min (19 pages) of the focus group discussion was transcribed (21 316 words). Themes were agreed by two raters (median agreement κ 0.89) and they included: need for a training curriculum (inter-rater agreement κ 0.85); identification of learning needs (κ 0.83); development of the curriculum contents (κ 0.81); an overview of available curricula (κ 0.79); settings for robotic surgery training ((κ 0.89); assessment and training of trainers (κ 0.92); requirements for certification and patient safety (κ 0.83); and need for a universally standardised curriculum (κ 0.78). A training curriculum was proposed based on the above discussions. CONCLUSION: This group proposes a multi-step curriculum for robotic training. Studies are in process to validate the effectiveness of the curriculum and to assess transfer of skills to the operating room.


Assuntos
Currículo , Robótica/educação , Procedimentos Cirúrgicos Urológicos/educação , Procedimentos Cirúrgicos Urológicos/métodos , Urologia/educação , Consenso , Humanos
4.
Eur Urol ; 66(1): 87-97, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24560818

RESUMO

CONTEXT: Live surgery is an important part of surgical education, with an increase in the number of live surgery events (LSEs) at meetings despite controversy about their real educational value, risks to patient safety, and conflicts of interest. OBJECTIVE: To provide a European Association of Urology (EAU) policy on LSEs to regulate their organisation during urologic meetings. EVIDENCE ACQUISITION: The project was carried out in phases: a systematic literature review generating key questions, surveys sent to Live Surgery Panel members, and Internet- and panel-based consensus finding using the Delphi process to agree on and formulate a policy. EVIDENCE SYNTHESIS: The EAU will endorse LSEs, provided that the EAU Code of Conduct for live surgery and all organisational requirements are followed. Outcome data must be submitted to an EAU Web-based registry and complications reported using the revised Martin criteria. Regular audits will take place to evaluate compliance as well as the educational role of live surgery. CONCLUSIONS: This policy represents the consensus view of an expert panel established to advise the EAU. The EAU recognises the educational role of live surgery and endorses live case demonstration at urologic meetings that are conducted within a clearly defined regulatory framework. The overriding principle is that patient safety must take priority over all other considerations in the conduct of live surgery. PATIENT SUMMARY: Controversy exists regarding the true educational value of live surgical demonstrations on patients at surgical meetings. An EAU committee of experts developed a policy on how best to conduct live surgery at urologic meetings. The key principle is to ensure safety for every patient, including a code of conduct and checklist for live surgery, specific rules for how the surgery is organised and performed, and how each patient's results are reported to the EAU. For detailed information, please visit www.uroweb.org.


Assuntos
Equipe de Assistência ao Paciente/organização & administração , Políticas , Sociedades Médicas , Procedimentos Cirúrgicos Urológicos/educação , Urologia/educação , Europa (Continente) , Humanos , Equipe de Assistência ao Paciente/normas , Segurança do Paciente/normas , Seleção de Pacientes , Procedimentos Cirúrgicos Urológicos/normas , Urologia/organização & administração , Urologia/normas
5.
BJU Int ; 112(7): 953-8, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23937141

RESUMO

OBJECTIVE: To present a series of 15 laparoscopic and robot-assisted Mitrofanoff and Yang-Monti vesicostomies in an adult population, and to assess the feasibility and safety of these minimally invasive approaches. PATIENTS AND METHODS: Between 2009 and 2012, 15 patients underwent laparoscopic (n = 11) or robot-assisted (n = 4) construction of vesicostomy by a single surgeon (D.R.): Mitrofanoff appendicovesicostomy (n = 11) or double Yang-Monti ileal conduit (n = 4). Fourteen patients underwent concomitant augmentation enterocystoplasty. Indications for surgery included neurogenic bladder (n = 11) and urethral dysfunction (n = 4). The patients were evaluated postoperatively using cystography. Quality of life (QoL) was evaluated using an internally developed questionnaire. RESULTS: All surgeries were successfully completed with no conversions. Operating time was always <5 h. The mean estimated blood loss was 150 mL and the mean follow-up was 22 months. Early postoperative complications included deep retrovesical abscess (n = 2) and upper urinary tract infections (n = 4), and one patient had peri-operative cardiac failure. Late postoperative complications included stomal stenosis (n = 2), persistent low-pressure bladder incontinence (n = 1) and recurrent infections (n = 1). Surgical excision of the conduit was necessary in one patient. Postoperatively, patients showed complete bladder emptying and no leak on follow-up cystography. According to our QoL questionnaire, 13/15 patients did not regret the surgery. CONCLUSIONS: While a longer follow-up is needed to assess the durability of our results, this series shows that the laparoscopic and robot-assisted approaches for the construction of continent urinary diversions are feasible and safe in an adult population.


Assuntos
Cistostomia/métodos , Laparoscopia , Robótica , Doenças da Bexiga Urinária/cirurgia , Derivação Urinária/métodos , Coletores de Urina , Adulto , Idoso , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Adulto Jovem
6.
Urology ; 82(2): 480-4, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23706553

RESUMO

OBJECTIVE: To report the feasibility of a novel robotic technique for intracorporeal construction of a double Yang-Monti ileal conduit with bladder augmentation in an adult patient. METHODS: The Yang-Monti procedure can be considered as an alternative to Mitrofanoff appendicovesicostomy when the appendix is not available or in obese patients. To date, the robotic approach has not been described. We have described all the steps of our surgery, performed on a 35-year-old obese patient with post-traumatic paraplegia and a neurogenic bladder. We focused on the technical tips and highlighted all the differences with the standard open technique. RESULTS: Our technique provided satisfactory results. No intraoperative complications occurred. The operative time was 250 minutes, and the intraoperative blood loss was 200 mL. The clinical course was uneventful. CONCLUSION: We have shown that robotic intracorporeal realization of a double Yang-Monti ileal conduit with bladder augmentation is feasible, extending the potential indications of robot-assisted surgery. The evaluation of more cases is advised.


Assuntos
Bexiga Urinaria Neurogênica/cirurgia , Bexiga Urinária/cirurgia , Derivação Urinária/métodos , Coletores de Urina , Adulto , Estudos de Viabilidade , Feminino , Humanos , Obesidade/complicações , Paraplegia/complicações , Robótica , Bexiga Urinaria Neurogênica/complicações
7.
Curr Urol Rep ; 10(2): 93-6, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19239812

RESUMO

Choosing laparoscopy is an important investment for urologists, and it must be learned from basic principles to advance skills through a steep learning curve; the caseload is made of frequent but very demanding procedures. In training centers, scholars are confronted with real-life conditions through large animal models. For about 1500 urologists, the European Institute of Tele Surgery has offered such a program for a decade. We evaluate its impact through a self-administered, Internet-hosted questionnaire. Individual data concern number and type of courses attended, skill level and type of practice before training, and expectations at registration. Personal benefit is evaluated through the delay before starting routine laparoscopy or the major procedures volume facing open counterparts. The ability of this program to meet scholar's expectations is reflected by eventual need for further training or by trainee suggestions. In spite of 85% cumulated satisfaction index, further developments must improve practical training: clear, reproducible stepwise protocols, repeated under supervision in animal models today and hopefully in augmented reality simulators tomorrow. The knowledge transfer and companionship made of theoretical and practical lessons followed by a straight supervised application represent an essential model for gaining proficiency.


Assuntos
Competência Clínica , Educação Médica Continuada/organização & administração , Laparoscopia , Procedimentos Cirúrgicos Urológicos/educação , Endoscopia/educação , França , Humanos , Modelos Animais , Modelos Educacionais , Inquéritos e Questionários , Urologia/educação
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