UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety Assessment of Adenomyomectomy by Loop Electrosurgical Excision Procedur
Title of the study (Brief title)	Safety Assessment of Adenomyomectomy
Region	Japan

Condition
Condition	Adenomyosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the safty of adenomyomectomy using loop electrosurgical excision procedure.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive outcome of this study is not to perform unexpected hysterectomy during surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	adenomyomectomy using loop electrosurgical excision procedure
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 with adenomyosis who want to undergo adenomyomectomy using loop electrosurgical excision procedure
Key exclusion criteria	1. postmenopausal patients 2. Patients with severe complications in vital organs 3. Patients with communication diffuculty 4. Patients whom the doctors in attendance do not qualify to participate in this study
Target sample size	10

Research contact person
Name of lead principal investigator	Yasushi Hirota
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics and Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	yhirota-tky@umin.ac.jp

Public contact
Name of contact person	Yasushi Hirota
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics and Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	yhirota-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 12 Day
Anticipated trial start date	2015 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 10 Day
Last modified on	2016 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020698