RCT-evaluation of Retzius-sparing Robotic Prostatectomy

March 23, 2020 updated by: Joanne N. Nyarangi-Dix, M.D., Heidelberg University

Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany
        • University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Retzius-sparing RARP
Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP
Procedure: robotic Prostatectomy (RARP)
Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP
Other: anterior transperitoneal RARP
Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
Procedure: robotic Prostatectomy (RARP)
Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary continence
Time Frame: 1 Week after Prostatectomy
Pad use
1 Week after Prostatectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resection margine
Time Frame: pathology report, approximately 1 week postoperatively
pathology report, approximately 1 week postoperatively
Urinary continence
Time Frame: 3, 6 and 12 months after Prostatectomy
Pad use
3, 6 and 12 months after Prostatectomy
Postoperative complications
Time Frame: First 12 months after Prostatectomy
First 12 months after Prostatectomy
postoperative PSA
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (Actual)

December 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transdouglas RCT-Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

So far, no sharing planed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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