Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Complete recovery of urinary continence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Complication(6 months)
- Self perception (QoL) of urinary function at 3 months(3 months)
- Total operative time(At the day of surgery)
- Estimated blood loss(At the day of surgery)
- Duration of social continence recovery(6 months)
- Continence score at 3 months(3 months)
- Urinary leak at 3 months(3 months)
Investigators
Sang Eun Lee
Professor
Seoul National University Bundang Hospital