UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017063
Receipt number R000019788
Scientific Title Randomized controlled trial on the evaluation of the vascularity of the myometrium after two suturing methods in Laparoscopic Myomectomy
Date of disclosure of the study information 2015/04/07
Last modified on 2021/10/12 13:42:40

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Basic information

Public title

Randomized controlled trial on the evaluation of the vascularity of the myometrium after two suturing methods in Laparoscopic Myomectomy

Acronym

Randomized controlled trial on the evaluation of vascularity after Laparoscopic Myomectomy

Scientific Title

Randomized controlled trial on the evaluation of the vascularity of the myometrium after two suturing methods in Laparoscopic Myomectomy

Scientific Title:Acronym

Randomized controlled trial on the evaluation of vascularity after Laparoscopic Myomectomy

Region

Japan


Condition

Condition

Uterine myoma

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the vascularity of the myometium after two different suturing methods in laparoscopic myomectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of vacularity of the myometrium after surgery using contrast-enhanced MRI

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Continuos suturing of the myometrium

Interventions/Control_2

Single interrupted suturing of the myometrium

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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

Women who have symptomatic intramural uterine myomas and are candidates for laparoscopic myomectomy

Key exclusion criteria

Asthma or other diseases contraindicative for contrast-enhancer

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihisa Fujimoto

Organization

Sanraku Hospital

Division name

Obstetrics and Gynecology

Zip code


Address

2-5, Kanda-Surugadai, Chiyodaku, Tokyo, Japan

TEL

03-3292-3981

Email

fujimoto-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihisa Fujimoto

Organization

Sanraku Hospital

Division name

Obstetrics and Gynecology

Zip code


Address

2-5, Kanda-Surugadai, Chiyodaku, Tokyo, Japan

TEL

03-3292-3981

Homepage URL


Email

fujimoto-tky@umin.ac.jp


Sponsor or person

Institute

Sanraku Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2015 Year 04 Month 07 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

Terminated

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB

2014 Year 12 Month 01 Day

Anticipated trial start date

2015 Year 02 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 07 Day

Last modified on

2021 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name