- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07899268
Continence Post Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy (Continence)
Retzius-Sparing Versus Standard Robot-Assisted Radical Prostatectomy: A Prospective Randomized Comparison on Immediate Continence Rates Using Versius Robotic System
To compare the short term (three month) continence rates using versius robotic system between the Retzius-sparing and the standard RARP within three month from removal of catheter.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Prostate cancer has the highest incidence rate and second highest mortality rate among cancers in men, accounting for a significant portion of new cancer diagnoses and cancer-related deaths.
Robot-Assisted Radical Prostatectomy (RARP) has become a standard treatment for localized prostate cancer, offering advantages such as reduced blood loss, shorter hospital stays, and quicker recovery compared to traditional open surgery. The use of advanced robotic platforms, including the Versius robotic system, has significantly improved precision in prostatectomy procedures.
Urinary continence remains one of the most important functional outcomes for patients undergoing radical prostatectomy. Despite advances in surgical techniques, many patients experience transient postoperative incontinence, which significantly impacts quality of life. The preservation of the puboprostatic ligaments and anterior bladder structures during surgery has been identified as a key factor in reducing the risk of incontinence.
Radical prostatectomy can be performed open, laparoscopically, or robot-assisted. Minimally invasive radical prostatectomy has become more common, utilizing two primary approaches for RARP: the standard/anterior approach and the Retzius-sparing/posterior approach (RS-RARP). In RS-RARP, the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space and leading to major improvements in functional outcomes, particularly immediate continence recovery.
Urinary incontinence remains one of the main risks following radical prostatectomy regardless of the surgical technique used. Incontinence rates can vary depending on the assessment questionnaires utilized, such as the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). Total urinary continence after catheter removal increases progressively over time.
Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) is reported to be associated with better immediate continence compared to the standard anterior approach, with no differences observed in longer-term functional recovery, quality of life, or other key outcomes. Furthermore, potency and serious complication rates appear comparable, showing no significant differences in the preservation of erectile function or overall postoperative complication rates between the two techniques.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Urology Department, Kasr Al-Ainy school of medicine,Cairo University
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Cairo Governorate
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Cairo, Cairo Governorate, Egipto
- Armed Forces College of Medicine , Cairo, Egypt.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical Stage: Clinical T1-3 N0 M0 prostate cancer.
- Prostate Size: Less than 100 gm.
Exclusion Criteria:
- Patients refusing Surgery.
- Patients unfit for surgery.
- History of previous TURP.
- Salvage Prostatectomy.
- Post Biopsy Febrile Prostatitis.
- Patients with retention and voiding dysfunction.
- Body mass index > 40
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Retzius-Sparing Robot-Assisted Radical Prostatectomy (RS-RARP)
Patients undergo Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) using the Versius robotic system. |
Patients undergo Retzius-sparing (posterior) robot-assisted radical prostatectomy using the Versius robotic system, where the prostate is removed entirely through the rectovesical space, resulting in the preservation of all structures in the Retzius space.
Otros nombres:
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Comparador activo: Standard Robot-Assisted Radical Prostatectomy (S-RARP)
Patients undergo standard (anterior) robot-assisted radical prostatectomy (S-RARP) using the Versius robotic system. |
Patients undergo standard (anterior) robot-assisted radical prostatectomy using the Versius robotic system through Retzius space
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Urinary Continence (0-1 pads/day)
Periodo de tiempo: 1 week after catheter removal
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The proportion of patients who achieve urinary continence (defined as the need for 0-1 pad per day) within a specified postoperative period e.g., 7 days or 30 days or 3 months. |
1 week after catheter removal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Continence at 1 and 3 months
Periodo de tiempo: 1 and 3 months after catheter removal
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ICIQ-UI score at 1 month and 3 months after catheter removal |
1 and 3 months after catheter removal
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Assessing positive surgical margins
Periodo de tiempo: 1 week and 3 months
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Assessment of PSMs postoperatively to assess the oncological outcomes and assessment of PSA level at 3 months |
1 week and 3 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Skornick-Rapaport A, Maslovitz S, Kupferminc M, Lessing JB, Many A. Proposed management for reduced fetal movements: five years' experience in one medical center. J Matern Fetal Neonatal Med. 2011 Apr;24(4):610-3. doi: 10.3109/14767058.2010.511338. Epub 2010 Sep 9.
- White AA 3rd. Resident selection: are we putting the cart before the horse? Clin Orthop Relat Res. 2002 Jun;(399):255-9. doi: 10.1097/00003086-200206000-00032.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Robotic Radical Prostatectomy
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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