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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007591
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Juntendo UniversityHospital
Department of Obstetrics and Gynecology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008925

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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