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

Seoul National University

Status: Completed

Conditions: Localized Prostate Cancer; Urinary Incontinence

Treatments: Procedure: Posterior reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01714219

SNUBH-URO-2012-02

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Posterior reconstruction

Experimental group

Description:

* 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

Treatment:

Procedure: Posterior reconstruction

No posterior reconstruction

No Intervention group

Description:

* 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