UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046350 |
|---|---|
| Receipt number | R000052885 |
| Scientific Title | Efficacy of microwave endometrial ablation for patients with previous uterine surgery: Retrospective study |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2021/12/10 16:43:21 |
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Basic information
Public title
Efficacy of microwave endometrial ablation for patients with previous uterine surgery: Retrospective study
Acronym
Efficacy of microwave endometrial ablation for patients with previous uterine surgery: Retrospective study
Scientific Title
Efficacy of microwave endometrial ablation for patients with previous uterine surgery: Retrospective study
Scientific Title:Acronym
Efficacy of microwave endometrial ablation for patients with previous uterine surgery: Retrospective study
Region
| Japan |
Condition
Condition
hypermenorrhea
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
MEA (microwave endometrial ablation) is a treatment that can control hypermenorrhea. With the increase in the number of cesarean sections and myomectomies, the increasing number of patients with MEA have undergone previous incision of the uterine myometrium and this causes thinning of the myometrium. Uterine perforation is major complication. Here we compared the incidence of complications and recurrence between groups with or without previous uterine surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age, gender, diagnosis, number of pregnancy, number of births, number of history of uterine surgery
Surgical details, preoperative ultrasound / MRI findings, surgical procedure restrictions, recurrence, adverse events and their contents
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
The subjects were 35 patients who were diagnosed with menorrhagia and underwent MEA at Nihon University Hospital between February 1, 2013 and March 31, 2020.
Key exclusion criteria
malignancy
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Maebayashi |
Organization
Nihon University Hospital
Division name
Gynecology
Zip code
101-8309
Address
1-6 Kanda Surugadai, Chiyoda-ku, Tokyo, 101-8309, Japan
TEL
03-3293-1711
maebayashi.aki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Maebayashi |
Organization
Nihon University Hospital
Division name
Gynecology
Zip code
101-8309
Address
1-6 Kanda Surugadai, Chiyoda-ku, Tokyo, 101-8309, Japan
TEL
03-3293-1711
Homepage URL
maebayashi.aki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University 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
Nihon University Hospital
Address
1-6 Kanda Surugadai, Chiyoda-ku, Tokyo, 101-8309, Japan
Tel
03-3293-1711
maebayashi.aki@nihon-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 15 | 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
35
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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052885
