Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy
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|ClinicalTrials.gov Identifier: NCT01714219|
Recruitment Status : Completed
First Posted : October 25, 2012
Last Update Posted : September 29, 2014
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 or disease||Intervention/treatment||Phase|
|Localized Prostate Cancer Urinary Incontinence||Procedure: Posterior reconstruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Posterior reconstruction
||Procedure: Posterior reconstruction|
No Intervention: No posterior reconstruction
- 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.
- Duration of social continence recovery [ Time Frame: 6 months ]Defined as 0 or 1 measured by EPIC question 5.
- Continence score at 3 months [ Time Frame: 3 months ]
By EPIC question 5.
- 0 vs. 1-3
- mean value
- Urinary leak at 3 months [ Time Frame: 3 months ]
By EPIC question 1,
- 1-3 vs. 4-5
- mean value
- Self perception (QoL) of urinary function at 3 months [ Time Frame: 3 months ]
By EPIC question 7,
- 0-1 vs. 2-4
- mean value
- Total operative time [ Time Frame: At the day of surgery ]
- Total operative time
- Console time
- Estimated blood loss [ Time Frame: At the day of surgery ]
- Complication [ Time Frame: 6 months ]Complication by modified Clavien-Dindo grade
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714219
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi-do, Korea, Republic of, Gyeonggi-do|
|Principal Investigator:||Sang Eun Lee, M.D., Ph.D.||Seoul National University Bundang Hospital|