臨床研究等提出・公開システム

Scientific Title	Efficacy of transvaginal antibiotic treatment in preventing recurrence after cystectomy for endometriomas.
Public Title	Efficacy of transvaginal antibiotic treatment in preventing recurrence after cystectomy for endometriomas.

Completion date	Feb. 01, 2024
Result actual enrolment	0
Baseline Characteristics	N/A
Participant flow	The number of applicable surgical cases decreased, and no cases were available to participate in this study.
Adverse events	N/A
Outcome measures	N/A
Brief summary	The number of applicable surgical cases decreased, and no cases were available to participate in this study.
Date of posting of results summaries	Feb. 28, 2024
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	N/A
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs041210114

Contact for Scientific Queries	Name	Osuka Satoko
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2261
	E-mail	satokoosuka@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Osuka Satoko
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
	Telephone	+81-52-744-2261
	E-mail	satokoosuka@med.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 01, 2022
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients after cystectomy for endometriomas 2. Patients who are not applicable for pseudo-menopausal therapy with hormonal treatment after cystectomy 3. Patients whose endometrium are positive for bacteria that are causative agents of ovarian endometriotic cysts 4. Written informed consent
	Exclusion Criteria	1.Patients with hypersensitivity to metronidazole 2.Patients who continue to use GnRHa, LEP or OC as hormonal therapy for the treatment of endometriosis after surgery 3. Patients whom the doctor considers unsuitable
	Age Minimum	20age old over
	Age Maximum	50age old under
	Gender	Female
Health Condition(s) or Problem(s) Studied		Ovarian endometrial cyst
Intervention(s)		Administration of trans-vaginal antibiotics
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Recurrence rate of ovarian endometriotic cysts
Secondary Outcome(s)		Time to recurrence of endometriosis, Rate of adverse events, Menstrual pain and non-menstrual pain ratings (general patient assessment (VAS), general physician assessment (VAS))

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya University Clinical Research Review Board
Address	65 Tsurumai-cho,Showak-ku,Nagoya city,Aichi,JAPAN, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 07, 2021

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 28, 2024	(this page)	Changes
1	Dec. 21, 2021	Detail

List of change history