NCT03787823

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

September 4, 2018

Last Update Submit

March 23, 2020

Conditions

Prostate CancerUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • Urinary continence

    Pad use

    1 Week after Prostatectomy

Secondary Outcomes (4)

  • Resection margine

    pathology report, approximately 1 week postoperatively

  • Urinary continence

    3, 6 and 12 months after Prostatectomy

  • Postoperative complications

    First 12 months after Prostatectomy

  • postoperative PSA

    12 months

Study Arms (2)

Retzius-sparing RARP

OTHER

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

Procedure: robotic Prostatectomy (RARP)

anterior transperitoneal RARP

OTHER

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

Procedure: robotic Prostatectomy (RARP)

Interventions

robotic Prostatectomy (RARP)PROCEDURE

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

Retzius-sparing RARPanterior transperitoneal RARP

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for radical prostatectomy
  • \>18 years old
  • Literate
  • Preoperatively continent
  • informed signed consent for study

You may not qualify if:

  • cT4-Cancer
  • Withdrawl of consent to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, Germany

Location

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief senior physician and Vice chairlady of the Dept. of Urology

Study Record Dates

First Submitted

September 4, 2018

First Posted

December 26, 2018

Study Start

August 27, 2018

Primary Completion

August 31, 2020

Study Completion

November 30, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

DE(1)