UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007883 |
|---|---|
| Receipt number | 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 16:11:37 |
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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
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/
yu.uro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Yamaguchi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009182
