Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy
NCT ID: NCT01714219
Last Updated: 2014-09-29
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-10-31
2014-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Posterior reconstruction
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
No interventions assigned to this group
Interventions
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Posterior reconstruction
Eligibility Criteria
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Inclusion Criteria
* patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon (Sang Eun Lee)
Exclusion Criteria
* prior radiation treatment on prostate or pelvis
* preoperative urinary incontinence
* refused to participate
MALE
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Sang Eun Lee
Professor
Principal Investigators
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Sang Eun Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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SNUBH-URO-2012-02
Identifier Type: -
Identifier Source: org_study_id
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