Suspended
PRRDoes the Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy? A Multicenter Randomized Controlled Trial. A Phase III Open-label Prospective International Multicenter Randomized Controlled Study for the Evaluation of the Efficacy of PRR, in Patients Subjected to RALP, Measured in Terms of Early Recovery of the Continence.
What is being tested
Posterior reconstruction of the rhabdosphincter
Procedure
Who is being recruted
Urogenital Diseases+8
+ Female Urogenital Diseases and Pregnancy Complications
+ Signs and Symptoms
From 18 to 80 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 2013
Summary
Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactBernardo Rocco, MDMore contacts
Last updated: March 13, 2013Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.The present study is a multicenter randomized, controlled trial, whose aim is to verify the effect of the posterior reconstruction of the rhabdosphincter after robot-assisted radical prostatectomy on early recovery of urinary continence.
Principal SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study ContactBernardo Rocco, MDMore contacts
Last updated: March 13, 2013Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1500 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrinary Incontinence
Criteria
4 inclusion criteria required to participate
Age >= 18 and <= 80 years
Biopsy proven clinically localized prostate cancer
Informed consent obtained and signed
Understanding of, and willingness to comply with, the study procedures
4 exclusion criteria prevent from participating
History of psychiatric or addictive disorder or other medical condition that, in the opinion of the investigator, would preclude the patient from meeting the trial requirements
Pre-operative incontinence
Salvage prostatectomy (defined as a prostatectomy prescribed after the failure of a different primary treatment)
Surgical posterior plane at the peri - rectal fat, without preserving an edge of the Denonvilliers
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalThese patients will receive reconstruction of the muscolofascial plate after radical prostatectomy. The reconstruction will be performed using two 3-0 Poliglecaprone sutures (on RB-1 needles) tied together, with each individual length being 12-15 cm. seven - Ten knots will be placed when tying the sutures to provide a bolster. The free edge of the remaining Denonvillier's fascia will be identified after the prostatectomy and approximated to the posterior aspect of the rhabdosphincter and the posterior median raphe using one arm of the continuous suture. As a rule, four passes will be taken from the right to the left and the suture is locked. The second layer of the reconstruction will be then performed with the other arm of the suture approximating the posterior lip of the bladder neck (full thickness) and the vesicoprostatic muscle to the posterior urethral edge and to the already reconstructed median raphe .This suture will be then tied to the end of the first suture arm.
Group II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, ItalyOpen Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico in Google MapsSuspendedOne Study Center