Single-Port Versus Multi-Port Robotic Radical Prostatectomy
A legfontosabb adatok
- Ki végzi
- Case Comprehensive Cancer Center
- Hol
- Cleveland (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Kezdés
- 2022. szept. 1.
- Befejezés
- 2025. márc.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
- Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- A regiszteradat frissítve
- 2025. március 10.
- Miért állt le
- Study closure based on study population not found and not enough study staff
Ki vehet részt
- Életkor
- 19 év felett
- Nem
- Csak férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging
- Life expectancy greater than 10 years
- Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy
Ki nem vehet részt
- Participants with any prior extensive pelvic surgery or pelvic fractures
- Prior treatment for prostate cancer such as radiotherapy or focal therapy
- Poor surgical risk (defined as American Society of Anesthesiology score > 3)
- Active soft tissue or urinary infection
- Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncorrected coagulopathy
Helyszínek itt: Egyesült Államok
- Case Comprehensive Cancer CenterCleveland, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.
A vizsgálat 2 csoportja
- Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)Már használt kezelés, összehasonlításként
All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® SP system. Access point consists of one 3.5 cm single infraumbilical incision for the SP-RARP
Kezelés: Da Vinci ® SP system - SP Robotic Radical Prostatectomy
- Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)Már használt kezelés, összehasonlításként
All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® Xi system, where four 8mm trocars will be used along with a 12 mm assistant trocar (a surgical instrument) to create six small incisions during the surgery
Kezelés: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy
- A regiszteradat frissítve
- 2025. március 10.