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

Primary Purpose

Localized Prostate Cancer, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Posterior reconstruction
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Prostate Cancer focused on measuring prostatic neoplasms, prostatectomy, robotics, urinary incontinence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Posterior reconstruction

No posterior reconstruction

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete recovery of urinary continence
Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2012
Last Updated
September 25, 2014
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01714219
Brief Title
Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy
Official Title
Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Prostate Cancer, Urinary Incontinence
Keywords
prostatic neoplasms, prostatectomy, robotics, urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior reconstruction
Arm Type
Experimental
Arm Description
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
Arm Title
No posterior reconstruction
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Posterior reconstruction
Primary Outcome Measure Information:
Title
Complete recovery of urinary continence
Description
Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Duration of social continence recovery
Description
Defined as 0 or 1 measured by EPIC question 5.
Time Frame
6 months
Title
Continence score at 3 months
Description
By EPIC question 5. 0 vs. 1-3 mean value
Time Frame
3 months
Title
Urinary leak at 3 months
Description
By EPIC question 1, 1-3 vs. 4-5 mean value
Time Frame
3 months
Title
Self perception (QoL) of urinary function at 3 months
Description
By EPIC question 7, 0-1 vs. 2-4 mean value
Time Frame
3 months
Title
Total operative time
Description
Total operative time Console time
Time Frame
At the day of surgery
Title
Estimated blood loss
Time Frame
At the day of surgery
Title
Complication
Description
Complication by modified Clavien-Dindo grade
Time Frame
6 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Eun Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

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

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