RCT-evaluation of Retzius-sparing Robotic Prostatectomy

Heidelberg University

Status: Unknown

Conditions: Prostate Cancer; Urinary Incontinence

Treatments: Procedure: robotic Prostatectomy (RARP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03787823

Transdouglas RCT-Study

Details and patient eligibility

About

Prospective randomized blinded RCT comparing Transdouglas Prostatectomy to classical transperitoneal anterior radical prostatectomy

Full description

We will evaluate functional urinary and sexual recovery, oncologic outcomes and postoperative complications in patients over a follow up period of 12 months

Enrollment: 186 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for radical prostatectomy
• >18 years old
• Literate
• Preoperatively continent
• informed signed consent for study

Exclusion criteria

• cT4-Cancer
• Withdrawl of consent to study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Retzius-sparing RARP

Other group

Description:

Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP

Treatment:

Procedure: robotic Prostatectomy (RARP)

anterior transperitoneal RARP

Other group

Description:

Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP

Treatment:

Procedure: robotic Prostatectomy (RARP)