Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12 de julho de 2020 atualizado por: Binh Dan Hospital
This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.
Visão geral do estudo
Status
Status
Desconhecido
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon.
All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes.
These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.
Tipo de estudo
Tipo de estudo
Intervencional
Inscrição (Antecipado)
Inscrição
80
Estágio
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
Contato de estudo
- Nome: Hoang PC Nguyen, Associate Professor, MD, PhD
- Número de telefone: +84 913 719 346
- E-mail: npchoang@gmail.com
Estude backup de contato
- Nome: Linh NK Tran, MD, PhD
- Número de telefone: +84 989 047 088
- E-mail: khaclinh@gmail.com
Locais de estudo
-
-
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Ho Chi Minh City, Vietnã, 700000
- Recrutamento
- Binh Dan Hospital
-
Contato:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Número de telefone: +84 913 719 346
- E-mail: npchoang@gmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Adult men aged 18 years and over;
- Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
- Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
- Cognitively able to give written informed consent for participation;
- Elective procedure.
Exclusion Criteria:
- The patient lacks the ability to consent for themselves;
- Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
2
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Comparador Ativo: Robotic-assisted surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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Comparador Falso: Laparoscopic surgery
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The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The console time
Prazo: During the surgery
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The time which surgeon spends on the robot console by minuite
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During the surgery
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Mean of blood loss
Prazo: During the surgery
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Milliliter
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During the surgery
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Perioperative transfusion rate (%)
Prazo: Up to 1 month after operation
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The number of cases which will be transfused.
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Up to 1 month after operation
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The rate of positive surgical margins, extracapsular extension, seminal vesicle invasion, (5)perineural invasion, the number of lymph node yield and node involvement,
Prazo: Up to 1 week after operation
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Number of cases, based on the result of pathology.
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Up to 1 week after operation
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Number of blood units transfused
Prazo: Up to 1 week after operation
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Milliliter
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Up to 1 week after operation
|
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the rate of conversion to open surgery, the rate of intraoperative incidents (%),
Prazo: Up to 1 weeks after the surgery.
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Percentage
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Up to 1 weeks after the surgery.
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The postoperative recovery parameters using Numeric Pain Rating Scale (NPRS),
Prazo: Up to 3 month after surgery
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, in a total of 10 points, higher score means worse, with 0 means no pain and 10 is the worst pain.
The mean score will be calculated to reflect the post-operative pain.
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Up to 3 month after surgery
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Change of hemoglobin from baseline
Prazo: Up to 1 week after operation
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(mg/mL)
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Up to 1 week after operation
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The drainage time
Prazo: Up to 3 months after surgery
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(day),
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Up to 3 months after surgery
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To assess urethral catheter time, urethral catheter time
Prazo: Up to 3 months after surgery
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(day)
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Up to 3 months after surgery
|
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To assess bowel movement recovery time,
Prazo: Up to 1 week after surgery
|
(day)
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Up to 1 week after surgery
|
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To assess postoperative hospital stay
Prazo: Up to 1 month after surgery
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(day)
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Up to 1 month after surgery
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The rate of postoperative complications (including infections)
Prazo: in day 3, day 7, and 1 month after surgery.
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Percentage
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in day 3, day 7, and 1 month after surgery.
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PSA level in blood
Prazo: Before operation
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(mg/mL)
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Before operation
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PSA level in blood
Prazo: 6 weeks post-operation
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(mg/mL)
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6 weeks post-operation
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PSA level in blood
Prazo: 3 months post-operation
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(mg/mL)
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3 months post-operation
|
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PSA level in blood
Prazo: 6 months post-operation
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(mg/mL)
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6 months post-operation
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PSA level in blood
Prazo: 12 months post-operation
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(mg/mL)
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12 months post-operation
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local and regional recurrences on sonography
Prazo: through study completion, an average of 1 year
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including ultrasound when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on MRI
Prazo: through study completion, an average of 1 year
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including MRI when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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local and regional recurrences, on PET Scan
Prazo: through study completion, an average of 1 year
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including PET Scan, when PSA rising or any indication of recurrent
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through study completion, an average of 1 year
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Prazo: Preoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
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Preoperative
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Evaluating the pre and postoperative lower urinary tract symptoms using International Prostate Symptoms Scores (IPSS)
Prazo: 3 months postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
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3 months postoperative
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Prazo: 6 months, postoperative
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
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6 months, postoperative
|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Prazo: 12 months postoperative.
|
It contains seven questions related to symptoms related to BPH and one question related to the patient's perceived quality of life.
The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.
The sum score will be calculated and the mean score will be evaluated.
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12 months postoperative.
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Prazo: Preoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
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Preoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Prazo: 3 months, postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
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3 months, postoperative
|
|
Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Prazo: 6 months, postoperative.
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
6 months, postoperative.
|
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Prazo: 12 months postoperative
|
The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
The score ranges from 22 - 25 for Normal erectile function (no ED), 17 - 21 for Mild ED, 12 - 16 for Mild to moderate ED, 8 - 11 for Moderate ED, and from 1 - 7 for Severe ED (5 - 7, if a man had no opportunity to engage in sexual activity).
The mean score will be calculated.
|
12 months postoperative
|
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Prazo: Preoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
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Preoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Prazo: 3 months, postoperative.
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
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3 months, postoperative.
|
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Prazo: 6 months, postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
6 months, postoperative
|
|
The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Prazo: 12 months postoperative
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The mean score will be calculated.
|
12 months postoperative
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Diretor de estudo: Hung V Tran, MD, PhD, Binh Dan Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
1 de janeiro de 2019
Conclusão Primária (Antecipado)
Conclusão Primária
31 de dezembro de 2020
Conclusão do estudo (Antecipado)
Conclusão do estudo
31 de dezembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
13 de maio de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de julho de 2019
Primeira postagem (Real)
Primeira postagem
9 de julho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
14 de julho de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de julho de 2020
Última verificação
Última verificação
1 de julho de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- BD022019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .