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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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