- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Urology Department, Kasr Al-Ainy school of medicine,Cairo University
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Cairo Governorate
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Cairo, Cairo Governorate, Egypten
- Armed Forces College of Medicine , Cairo, Egypt.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Aktiv komparator: 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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Urinary Continence (0-1 pads/day)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Continence at 1 and 3 months
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Robotic Radical Prostatectomy
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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