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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007883
Receipt No. R000009182
Scientific Title A randomized study for running suture versus conventional interrupted suture for vesico-urethral anastomosis in patients with retropubic radical prostatectomy
Date of disclosure of the study information 2012/05/02
Last modified on 2014/11/02

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Basic information
Public title A randomized study for running suture versus conventional interrupted suture for vesico-urethral anastomosis in patients with retropubic radical prostatectomy
Acronym Running suture vs. interrupted suture in radical prostatectomy
Scientific Title A randomized study for running suture versus conventional interrupted suture for vesico-urethral anastomosis in patients with retropubic radical prostatectomy
Scientific Title:Acronym Running suture vs. interrupted suture in radical prostatectomy
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to elucidate whether the suture method, between running and interrupted suture, influence the postoperative condition such as delay of the catheter removal, urethral stricture, or recovery of continence in a randomized study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The period from post operation to removal of urethral catheter
Key secondary outcomes 1. Duration of hospitalization
2. Frequency of leakage of contrast medium at the time of cystography
3. Rate of urinary incontinence after catheter removal
4. Frequency of postoperative complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1) A number of cases: 60
2) The study period: 3 years (October 2010 to September 2013)

Method
1) After we obtain informed consents, we assigned to two groups, interrupted suture or running suture, which were randomly assigned. Stratification factor is the date of surgery. The allocation method is performed in the envelope method. In addition, patients who change anonymous, methods of suture, divided into surgery day with surgery Tuesday and Thursday, we give the number of cases No.1 to 30 in each group.
2) If the day of surgery is Tuesday, urethrocystography is done at sixth day after surgery and in the case of Thursday, we perform it at the fourth day after surgery. If no leakage from the anastomosis, we remove the urethral catheter in the same day. In case of leakage, we postpone the removal of urinary catheters and urethrocystopgraphy is performed again after 1 week.
3) After catheter removal, the amount of leakage and urinate volume is recorded by themselves on their own sheet. Then we describe rate of incontinence. In addition, the anticholinergic agent is not used for urinary incontinence after surgery. When it is necessary to use forced by the patient's wishes, we must describe a statement to that effect.
4) Basically, date of discharge is the next day of catheter removal. It depends on general condition and patient's wishes.
5) Interrupted suture is performed by conventional 6 points, 1, 3, 5, 7, 9, 11, o'clock interrupted suture using 2-0 polyglactin. Running suture was performed by 12 bite sutures starting from 6 to 12 o'clock direction using 3-0 poliglecaprone. Social continence rate is described, 0 or 1 pad a day, at 1, 3, 6 and 12 months after surgery.
Interventions/Control_2 1) A number of cases: 60
2) The study period: 3 years (October 2010 to September 2013)

Method
1) After we obtain informed consents, we assigned to two groups, interrupted suture or running suture, which were randomly assigned. Stratification factor is the date of surgery. The allocation method is performed in the envelope method. In addition, patients who change anonymous, methods of suture, divided into surgery day with surgery Tuesday and Thursday, we give the number of cases No.1 to 30 in each group.
2) If the day of surgery is Tuesday, urethrocystography is done at sixth day after surgery and in the case of Thursday, we perform it at the fourth day after surgery. If no leakage from the anastomosis, we remove the urethral catheter in the same day. In case of leakage, we postpone the removal of urinary catheters and urethrocystopgraphy is performed again after 1 week.
3) After catheter removal, the amount of leakage and urinate volume is recorded by themselves on their own sheet. Then we describe rate of incontinence. In addition, the anticholinergic agent is not used for urinary incontinence after surgery. When it is necessary to use forced by the patient's wishes, we must describe a statement to that effect.
4) Basically, date of discharge is the next day of catheter removal. It depends on general condition and patient's wishes.
5) Interrupted suture is performed by conventional 6 points, 1, 3, 5, 7, 9, 11, o'clock interrupted suture using 2-0 polyglactin. Running suture was performed by 12 bite sutures starting from 6 to 12 o'clock direction using 3-0 poliglecaprone. Social continence rate is described, 0 or 1 pad a day, at 1, 3, 6 and 12 months after surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 60 patients who will plan to perform radical prostatectomy for organ confined disease; the informed consents must be obtained from those patients. (Regardless of age)
Key exclusion criteria 1) Patients with a history of a urethral stricture.
2) Patients with a history of central nervous system damage such as cerebral hemorrhage and cerebral infarction.
3) Patients with peripheral neuropathy such as diabetes and rectal cancer surgery.
4) Patients with a history of bladder cancer and cancer of the urethra.
5) Patients whom physician may find to be inappropriate.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyasu Matsuyama
Organization Graduate School of Medicine Yamaguchi University
Division name Urology
Zip code
Address 1-1-1, Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2275
Email surol@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Matsumoto
Organization Graduate School of Medicine Yamaguchi University
Division name Urology
Zip code
Address 1-1-1, Minami-Kogushi, Ube, Yamaguchi
TEL 0836-22-2275
Homepage URL http://www.urol-yamaguchi.jp/
Email yu.uro@yamaguchi-u.ac.jp

Sponsor
Institute Graduate School of Medicine Yamaguchi University
Institute
Department

Funding Source
Organization Graduate School of Medicine Yamaguchi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1442-2042
Number of participants that the trial has enrolled
Results Title
Running sutures are feasible for vesicourethral anastomosis and beneficial for improving patients' quality of life A randomized study comparing running sutures with interrupted sutures in retropubic radical prostatectomy
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 05 Month 02 Day
Last modified on
2014 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009182

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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