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RCT-evaluation of Retzius-sparing Robotic Prostatectomy

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ClinicalTrials.gov Identifier: NCT03787823
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Joanne N. Nyarangi-Dix, M.D., Heidelberg University

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Incontinence Procedure: robotic Prostatectomy (RARP) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Urinary continence [ Time Frame: 1 Week after Prostatectomy ]
    Pad use


Secondary Outcome Measures :
  1. Resection margine [ Time Frame: pathology report, approximately 1 week postoperatively ]
  2. Urinary continence [ Time Frame: 3, 6 and 12 months after Prostatectomy ]
    Pad use

  3. Postoperative complications [ Time Frame: First 12 months after Prostatectomy ]
  4. postoperative PSA [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787823


Contacts
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Contact: Joanne nyaboe Nyarangi-Dix, Md, PhD +49-6221 ext 6110 Joan.Nyarangi-Dix@med.uni-heidelberg.de

Locations
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Germany
University of Heidelberg Recruiting
Heidelberg, Germany
Contact: Joanne Nyaboe Nyarangi-Dix, MD, PhD    +49-6221-566110    joan.nyarangi-dix@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University

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Responsible Party: Joanne N. Nyarangi-Dix, M.D., Chief senior physician and Vice chairlady of the Dept. of Urology, Heidelberg University
ClinicalTrials.gov Identifier: NCT03787823     History of Changes
Other Study ID Numbers: Transdouglas RCT-Study
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: So far, no sharing planed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders