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
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
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
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
