NCT04043637

Brief Summary

This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Status
completed

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

April 23, 2012

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 6, 2019

Status Verified

July 1, 2019

Enrollment Period

6.6 years

First QC Date

July 29, 2019

Last Update Submit

August 2, 2019

Conditions

Prostatic CancerSurgical Procedure, UnspecifiedUrinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • change in the proportion of patients with of urinary incontinence

    Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy

    The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery

Secondary Outcomes (3)

  • change in the proportion of patients with recovery of the erectile function

    every month during the first year after surgery

  • number of patients with overall positive surgical margins

    immediate postoperative period

  • biochemical recurrence rate

    until the completion of the study, with a mean follow-up of 72 months

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical Prostatectomy from 2012 to 2018, always performed by the same surgeon

You may qualify if:

  • Age between 40 and 75 years
  • A Body Mass Index lower than 35 Hg/m2
  • Patients with organ-confined prostate cancer
  • Signed informed consent

You may not qualify if:

  • Contraindications for Laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 2, 2019

Study Start

April 23, 2012

Primary Completion

December 3, 2018

Study Completion

April 10, 2019

Last Updated

August 6, 2019

Record last verified: 2019-07