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

NCT01714219 · Seoul National University Hospital · Updated 29 Sept 2014

What is being tested
Posterior reconstruction
For
Localized Prostate Cancer; Urinary Incontinence
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Not stated. About 100 people. The full rules are on the registry page.
Where
South Korea
When
Starts or started Oct 2012, ends March 2014. Registered 25 Oct 2012.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT01714219

Sites

  • Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-do, South Korea