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

Not Applicable

Completed

• Conditions: Urinary Incontinence; Localized Prostate Cancer
• Interventions: Procedure: Posterior reconstruction

• Registration Number: NCT01714219
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-19
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-25
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-25
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior reconstruction	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

Primary Outcome Measures

Name	Time	Method
Complete recovery of urinary continence	6 months	Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.

Secondary Outcome Measures

Name	Time	Method
Complication	6 months	Complication by modified Clavien-Dindo grade
Self perception (QoL) of urinary function at 3 months	3 months	By EPIC question 7,; * 0-1 vs. 2-4; * mean value
Total operative time	At the day of surgery	* Total operative time; * Console time
Estimated blood loss	At the day of surgery
Duration of social continence recovery	6 months	Defined as 0 or 1 measured by EPIC question 5.
Continence score at 3 months	3 months	By EPIC question 5.; * 0 vs. 1-3; * mean value
Urinary leak at 3 months	3 months	By EPIC question 1,; * 1-3 vs. 4-5; * mean value

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of