UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015747 |
|---|---|
| Receipt number | R000018326 |
| Scientific Title | Evaluation of risk factors for recurrence of ovarian endometrioma after conservative surgery in women with ovarian endometrioma |
| Date of disclosure of the study information | 2014/11/25 |
| Last modified on | 2024/06/01 12:09:16 |
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Basic information
Public title
Evaluation of risk factors for recurrence of ovarian endometrioma after
conservative surgery in women with ovarian endometrioma
Acronym
Risk factors for recurrence of ovarian endometrioma after surgery
Scientific Title
Evaluation of risk factors for recurrence of ovarian endometrioma after
conservative surgery in women with ovarian endometrioma
Scientific Title:Acronym
Risk factors for recurrence of ovarian endometrioma after surgery
Region
| Japan |
Condition
Condition
Ovarian endometrioma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of risk factors for recurrence of ovarian endometrioma after
conservative surgery in women with ovarian endometrioma
Basic objectives2
Others
Basic objectives -Others
Extraction of risk factors
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of recurrence of the ovarian endometrioma after surgery
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients who underwent conservative surgery in women with ovarian endometrioma.
Key exclusion criteria
Patients who underwent surgery with only excision or aspiration of ovarian endometrioma.
Patients with borderline or malignant ovarian tumor.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takahashi |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
990-9585
Address
2-2-2 iida-nishi, Yamagata
TEL
023-628-5393
totakaha@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takahashi |
Organization
Yamagata University Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
990-9585
Address
2-2-2 iida-nishi, Yamagata
TEL
023-628-5393
Homepage URL
http://www.id.yamagata-u.ac.jp/ObGyn/
totakaha@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Faculty of Medicine, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Tohoku Gynecologic Cancer Unit
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamagata University Faculty of Medicine
Address
Iida-nishi 2-2-2, Yamagata, Japana
Tel
023-633-1122
totakaha@medid.yamagata-u.ac.jp
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
山形大学医学部附属病院（山形県）、弘前大学医学部附属病院（青森県）、岩手医科大学病院（岩手県）、秋田大学医学部附属病院（秋田県）、東北大学医学部附属病院（宮城県）、福島県立医科大附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 25 | 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
| 2014 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is under ethics examination at each institution.
Management information
Registered date
| 2014 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018326
