RCT-evaluation of Retzius-sparing Robotic Prostatectomy

Not Applicable

• Conditions: Urinary Incontinence; Prostate Cancer
• Interventions: Procedure: robotic Prostatectomy (RARP)

• Registration Number: NCT03787823
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2018-08-27
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-26
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24
• Primary Completion: 2020-08-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior transperitoneal RARP	robotic Prostatectomy (RARP)	Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
Retzius-sparing RARP	robotic Prostatectomy (RARP)	Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP

Primary Outcome Measures

Name	Time	Method
Urinary continence	1 Week after Prostatectomy	Pad use

Secondary Outcome Measures

Name	Time	Method
postoperative PSA	12 months
Resection margine	pathology report, approximately 1 week postoperatively
Urinary continence	3, 6 and 12 months after Prostatectomy	Pad use
Postoperative complications	First 12 months after Prostatectomy

Trial Locations

Locations (1)

University of Heidelberg; 🇩🇪 Heidelberg, Germany