UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	maebayashi.aki@nihon-u.ac.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052885