RCT-evaluation of Retzius-sparing Robotic Prostatectomy

Heidelberg University186 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

186

Conditions

Prostate Cancer Urinary Incontinence

Interventions

robotic Prostatectomy (RARP)PROCEDURE

Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Heidelberg

Heidelberg, Germany

Outcomes

Primary Outcomes

Urinary continence

Pad use

Time frame: 1 Week after Prostatectomy

Secondary Outcomes

Resection margine

Time frame: pathology report, approximately 1 week postoperatively

Urinary continence

Pad use

Time frame: 3, 6 and 12 months after Prostatectomy

Postoperative complications

Time frame: First 12 months after Prostatectomy

postoperative PSA

Time frame: 12 months

Data from ClinicalTrials.gov

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