UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007591 |
|---|---|
| Receipt number | R000008925 |
| Scientific Title | Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy |
| Date of disclosure of the study information | 2012/03/29 |
| Last modified on | 2016/09/30 16:08:20 |
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Basic information
Public title
Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy
Acronym
Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy
Scientific Title
Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy
Scientific Title:Acronym
Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy
Region
| Japan |
Condition
Condition
Uterine myoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to confirm the superiority of a test treatment group using V-Loc180 to a current standard of care group using a multifilament suture Polysorb in patients undergoing Laparoscopic Myomectomy, using a randomized comparative study of the suturing time in the uterine wall defect etc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suturing time in the uterine wall defect
Key secondary outcomes
Blood loss
Amount of drainage
Duration of drain placement
Length of hospital stay
Adverse events(intraoperative and postoperative)
Degree of adhesion formation by second-look
Number of sutures used
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A:V-Loc180
Interventions/Control_2
Group B:Polysorb
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
Female
Key inclusion criteria
1) Interstitial myoma of the uterus
2) Myomas can be closed with single layer suture
3) Within 3 uterine fibroids
4) Within a 10cm. uterine fibroid in diameter
5) No history of gynecological surgery(myomectomy, systectomy)
6) Healthy organ function
7) Obtained the written informed consent
Key exclusion criteria
1) Active bacterial infection or fungal infection
2) Under continuing systemic administration (intravenous or oral) of steroids
3) Complicated condition with uncontrolled diabetes mellitus(HbA1c >8.0%).
4) Judged difficulty due to study complications related to a psychiatric disorder or psychological symptoms
5) Judged unsuitable patient for study participation by the investigator for any other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwaho Kikuchi M.D. |
Organization
Juntendo UniversityHospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwaho Kikuchi M.D. |
Organization
Juntendo UniversityHospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
Homepage URL
Sponsor or person
Institute
Juntendo UniversityHospital
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Covidien Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 28 | Day |
Last modified on
| 2016 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
