Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Sang Eun Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01714219
First received: October 19, 2012
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

Incontinence is one of the most common complications of radical prostatectomy. The continence rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP). However, some reports suggested that posterior reconstruction (PR) behind vesicourethral anastomosis could improve early recovery of continence during open, laparoscopic or robot-assisted radical prostatectomy.

But, recent prospective studies reported no benefit of PR after RALP, which was the opposite result of those of previous studies. However the PR techniques used in these prospective studies seem to be quite different from the previous techniques. They seem to have used single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder neck.

Our group identified this anatomic structure as the posterior counterpart of the detrusor apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step reconstruction between MDFR and PDA could be enough for PR. We previously investigated whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would improve continence recovery compared with the standard RALP technique without PR. And our retrospective study demonstrated that this new PR technique during RALP significantly shortens the time to the recovery of continence compared with the standard technique, which does not incorporate PR (Int J Urol, 2012;19:683-7).

Thus, we plan to validate this result by a well-designed, prospective, randomized controlled study.


Condition Intervention
Localized Prostate Cancer
Urinary Incontinence
Procedure: Posterior reconstruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Complete recovery of urinary continence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.


Secondary Outcome Measures:
  • Duration of social continence recovery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Defined as 0 or 1 measured by EPIC question 5.

  • Continence score at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    By EPIC question 5.

    • 0 vs. 1-3
    • mean value

  • Urinary leak at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    By EPIC question 1,

    • 1-3 vs. 4-5
    • mean value

  • Self perception (QoL) of urinary function at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    By EPIC question 7,

    • 0-1 vs. 2-4
    • mean value

  • Total operative time [ Time Frame: At the day of surgery ] [ Designated as safety issue: No ]
    • Total operative time
    • Console time

  • Estimated blood loss [ Time Frame: At the day of surgery ] [ Designated as safety issue: No ]
  • Complication [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Complication by modified Clavien-Dindo grade


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Posterior reconstruction
  • New posterior reconstruction, which entails opposition of the median dorsal fibrous raphe solely to the posterior counterpart of the detrusor apron
  • Vesicourethral anastomosis using the van Velthoven method
  • Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex
Procedure: Posterior reconstruction
No Intervention: No posterior reconstruction
  • No posterior reconstruction
  • Vesicourethral anastomosis using the van Velthoven method
  • Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pathologically proven localized prostate cancer (≤cT3a)
  • patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (Sang Eun Lee)

Exclusion Criteria:

  • prior hormone therapy
  • prior radiation treatment on prostate or pelvis
  • preoperative urinary incontinence
  • refused to participate
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714219

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, Gyeonggi-do
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Sang Eun Lee, M.D., Ph.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Sang Eun Lee, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01714219     History of Changes
Other Study ID Numbers: SNUBH-URO-2012-02
Study First Received: October 19, 2012
Last Updated: August 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
prostatic neoplasms
prostatectomy
robotics
urinary incontinence

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014