臨床研究等提出・公開システム

Scientific Title	Investigation of the efficacy of Vagi-pipe C type in total laparoscopic hysterectomy (New vaginal pipe trial)
Public Title	Investigation of the efficacy of the new vaginal pipe in total laparoscopic hysterectomy (New vaginal pipe trial)

Completion date	Sept. 30, 2020
Result actual enrolment	8
Baseline Characteristics	12 cases were uterine fibroids. Average age was 47.0 and BMI was 24.9 .
Participant flow	All 8 cases were appropriate to the inclusion criteria.
Adverse events	Nothing particular.
Outcome measures	Total operation time was 154.5 as primary outcome. As secondary outcomes, average blood loss was 64.4 and no adverse event was found.
Brief summary	The new type of vaginal pipe was safely introduced in our institution.
Date of posting of results summaries	Dec. 31, 2020

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs052180221

Contact for Scientific Queries	Name	Kitawaki Jo
	Affiliation	University Hospital Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
	Telephone	+81-75-251-5560
	E-mail	kitawaki@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Ito Fumitake
	Affiliation	Kyoto Prefectural University of Medicine, Graduate School of Medical Science
	Address	465 Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
	Telephone	+81-75-251-5560
	E-mail	fitoh@koto.kpu-m.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 05, 2016
Actual date of first enrollment		Aug. 24, 2016
Target sample size		10
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Women aged between 30 and 70
	Exclusion Criteria	Women with the decision of inappropriate
	Age Minimum	30age old
	Age Maximum	70age old
	Gender	Female
Health Condition(s) or Problem(s) Studied		Uterine myoma, Adenomyosis
Intervention(s)		Use of modified vaginal pipe instead of conventional vaginal pipe in total laparoscopic hysterectomy
Health Condition(s) Keyword		Uterine myoma, Adenomyosis
Health Condition(s) Code		D007889、D062788
Primary Outcome(s)		Operation time
Secondary Outcome(s)		Blood loss, complications

Name of Certified Review Board	Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address	465 Kajii-cho,Kawaramachi-Hirokoji, Kamigyo-ku,Kyoto, Kyoto
Telephone	+81-75-251-5337
E-Mail	rinri@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Mar. 06, 2019

Secondary ID(s)	UMIN000025893
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Feb. 17, 2021	(this page)	Changes
1	Mar. 27, 2019	Detail

List of change history