NCT04696263

Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Neoplasm of Prostate

Interventions

Type	Name	Description
DEVICE	Da Vinci ® Xi system - MP Robotic Radical Prostatectomy	After pneumoperitoneum is established, four 8mm, one 12 mm, and one 5 mm trocars are placed for instrumentation. After the robot is docked, radical prostatectomy is performed with the SOC approach.
DEVICE	Da Vinci ® SP system - SP Robotic Radical Prostatectomy	After induction of general anesthesia and supine participant positioning, a 3.5 cm infraumbilical incision will be made for single-port access into the space of Retzius. Radical prostatectomy is then performed with the SOC approach

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-01-06
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study