Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment
12 de julio de 2020 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Anticipado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ho Chi Minh City, Vietnam, 700000
- Reclutamiento
- Binh Dan Hospital
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Contacto:
- Hoang PC Nguyen, Associate Professor, MD, PhD
- Número de teléfono: +84 913 719 346
- Correo electrónico: npchoang@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The console time
Periodo de tiempo: 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
Periodo de tiempo: During the surgery
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Milliliter
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During the surgery
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Perioperative transfusion rate (%)
Periodo de tiempo: 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,
Periodo de tiempo: 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
Periodo de tiempo: 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 (%),
Periodo de tiempo: 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),
Periodo de tiempo: Up to 3 month after surgery
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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,
Periodo de tiempo: Up to 1 week after surgery
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(day)
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Up to 1 week after surgery
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To assess postoperative hospital stay
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Before operation
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(mg/mL)
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Before operation
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PSA level in blood
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluating the pre and postoperative lower urinary tract symptoms using Full score of International Prostate Symptoms Scores (IPSS)
Periodo de tiempo: Preoperative
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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)
Periodo de tiempo: 3 months postoperative
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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)
Periodo de tiempo: 6 months, postoperative
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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)
Periodo de tiempo: 12 months postoperative.
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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
Periodo de tiempo: Preoperative
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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
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Periodo de tiempo: 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
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Periodo de tiempo: 6 months, postoperative.
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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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6 months, postoperative.
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Erectile function assessments questionnaires and scoring using Index of Erectile Function Questionnaire, IIEF5, full score
Periodo de tiempo: 12 months postoperative
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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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12 months postoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Periodo de tiempo: Preoperative
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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
Periodo de tiempo: 3 months, postoperative.
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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
Periodo de tiempo: 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.
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6 months, postoperative
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The quality of life questionnaires and scoring using the the Short Form (36) Health Survey questionnaire
Periodo de tiempo: 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.
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12 months postoperative
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Hung V Tran, MD, PhD, Binh Dan Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2019
Finalización primaria (Anticipado)
31 de diciembre de 2020
Finalización del estudio (Anticipado)
31 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2019
Primero enviado que cumplió con los criterios de control de calidad
4 de julio de 2019
Publicado por primera vez (Actual)
9 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
12 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BD022019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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