UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Controlled Trial to evaluate the efficiency of absorbable barbed suture (V-Loc180) during Laparoscopic Myomectomy
Title of the study (Brief title)	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	Iwaho Kikuchi M.D.
Organization	Juntendo UniversityHospital
Division name	Department of Obstetrics and Gynecology
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
Email

Public contact
Name of contact person	Iwaho Kikuchi M.D.
Organization	Juntendo UniversityHospital
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008925