RCT-evaluation of Retzius-sparing Robotic Prostatectomy

NCT ID: NCT03787823

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2020-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Prostate Cancer Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Retzius-sparing RARP

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

Group Type OTHER

robotic Prostatectomy (RARP)

Intervention Type PROCEDURE

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

anterior transperitoneal RARP

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

Group Type OTHER

robotic Prostatectomy (RARP)

Intervention Type PROCEDURE

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

Interventions

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robotic Prostatectomy (RARP)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Joanne N. Nyarangi-Dix, M.D.

Chief senior physician and Vice chairlady of the Dept. of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Transdouglas RCT-Study

Identifier Type: -

Identifier Source: org_study_id

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