Does Posterior Reconstruction of the Rhabdosphincter Improve Early Recovery of Continence After Robotic-Assisted Radical Prostatectomy?

NCT ID: NCT01809522

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

Brief Summary

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Posterior reconstruction of the musculofascial plate

These 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 Type: EXPERIMENTAL

Posterior reconstruction of the rhabdosphincter

Intervention Type: PROCEDURE

Standard radical prostectomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Posterior reconstruction of the rhabdosphincter

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Bernardo Rocco

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Bernardo Rocco, MD

Role: CONTACT

bernardo.rocco@gmail.com

+390255034549

Facility Contacts

Bernardo Rocco, MD

Role: primary

bernardo.rocco@gmail.com

+390255034549

Other Identifiers

Posterior Reconstruction

Identifier Type: -

Identifier Source: org_study_id