Back to resultsRCT-evaluation of Retzius-sparing Robotic Prostatectomy
Primary Purpose
Prostate Cancer, Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
robotic Prostatectomy (RARP)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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
Sites / Locations
- University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Retzius-sparing RARP
anterior transperitoneal RARP
Arm Description
Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP
Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
Outcomes
Primary Outcome Measures
Urinary continence
Pad use
Secondary Outcome Measures
Resection margine
Urinary continence
Pad use
Postoperative complications
postoperative PSA
Full Information
NCT ID
NCT03787823
First Posted
September 4, 2018
Last Updated
March 23, 2020
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT03787823
Brief Title
RCT-evaluation of Retzius-sparing Robotic Prostatectomy
Official Title
Robotic Retzius-sparing Radical Prostatectomy- a Randomized Controlled Trial Evaluating Transdouglas-RARP
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retzius-sparing RARP
Arm Type
Other
Arm Description
Arm B randomizes men with an indication for radical robotic Prostatectomy (RARP) to retzius-sparing transdouglas RARP
Arm Title
anterior transperitoneal RARP
Arm Type
Other
Arm Description
Arm A randomizes men with an indication for radical robotic Prostatectomy (RARP) to anterior transperitoneal RARP
Intervention Type
Procedure
Intervention Name(s)
robotic Prostatectomy (RARP)
Intervention Description
Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP
Primary Outcome Measure Information:
Title
Urinary continence
Description
Pad use
Time Frame
1 Week after Prostatectomy
Secondary Outcome Measure Information:
Title
Resection margine
Time Frame
pathology report, approximately 1 week postoperatively
Title
Urinary continence
Description
Pad use
Time Frame
3, 6 and 12 months after Prostatectomy
Title
Postoperative complications
Time Frame
First 12 months after Prostatectomy
Title
postoperative PSA
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
So far, no sharing planed
Learn more about this trial
RCT-evaluation of Retzius-sparing Robotic Prostatectomy
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