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Completed

NCT Number: NCT01714219

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

posterior reconstruction

Procedure

Primary outcomes

  1. Complete recovery of urinary continence

    Time frame: 6 months

    Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.

Secondary outcomes

  1. Duration of social continence recovery

    Time frame: 6 months

    Defined as 0 or 1 measured by EPIC question 5.

  2. Continence score at 3 months

    Time frame: 3 months

    By EPIC question 5.

    • 0 vs. 1-3
    • mean value
  3. Urinary leak at 3 months

    Time frame: 3 months

    By EPIC question 1,

    • 1-3 vs. 4-5
    • mean value
  4. Self perception (QoL) of urinary function at 3 months

    Time frame: 3 months

    By EPIC question 7,

    • 0-1 vs. 2-4
    • mean value
  5. Total operative time

    Time frame: At the day of surgery

    • Total operative time
    • Console time
  6. Estimated blood loss

    Time frame: At the day of surgery

  7. Complication

    Time frame: 6 months

    Complication by modified Clavien-Dindo grade

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 25, 2012
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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