臨床研究等提出・公開システム

Scientific Title	Clinical assessment of preventive lymphaticovenous anastomosis surgery to improve postoperative lymphedema in lower limbs after total hysterectomy utilizing da Vinci Surgical System (Clinical assessment of lymphaticovenous anastomosis surgery utilizing da Vinci Surgical System)
Public Title	Clinical assessment of lymphaticovenous anastomosis surgery utilizing da Vinci Surgical System (Clinical assessment of lymphaticovenous anastomosis surgery utilizing da Vinci Surgical System)

Completion date	Sept. 15, 2020
Result actual enrolment	0
Baseline Characteristics	Not applicable
Participant flow	In October 2017, the study began patient enrollment. In June 2018, the study was reviewed for transfer to CRB as a specific clinical study. At that time, due to changes from endoscopy to robot-assisted surgery utilizing the da Vinci surgical system, changes in the primary endpoints and research design due to indications, and changes in the names of research projects, the examination of this study was conducted in July of the same year as a new application. The review was approved in August of the same year. This study was discontinued in September 2020 and completed in May 2021.
Adverse events	Not applicable
Outcome measures	Not applicable
Brief summary	Not applicable
Date of posting of results summaries	June. 07, 2021
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	Not applicable
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032180033

Contact for Scientific Queries	Name	Sasaki Hiroshi
	Affiliation	Medical Corporation Okinawa Tokushukai Chiba Tokushukai Hospital
	Address	2-11-1 Takanedai , Funabashi-shi , Chiba Japan
	Telephone	+81-474667111
	E-mail	hrssasaki0226@gmail.com
Contact for Public Queries	Name	Koga Rika
	Affiliation	Medical Corporation Okinawa Tokushukai Chiba Tokushukai Hospital
	Address	2-11-1 Takanedai , Funabashi-shi , Chiba Japan
	Telephone	+81-477740388
	E-mail	r.koga@chibatoku.or.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 23, 2018
Actual date of first enrollment
Target sample size		3
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Endometrial cancer, requiring pelvic and/or paraaortic lymphadenectomy.
	Exclusion Criteria	Cases in which robot-assisted surgery or lymphatic venous anastomosis is technically unfeasible or unnecessary, due to complications or other reasons.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Endometrial cancer
Intervention(s)		Lymphatic venous anastomosis utilizing da Vinci Surgical System
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D016889
Intervention(s) Code
Primary Outcome(s)		Intra and post-operative adverse events
Secondary Outcome(s)		post-operative lower limb lymphedema,prognosis

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Okinawa Tokusyukai Certified Review Board
Address	1370-1,Okamoto,Kamakura, Kanagawa
Telephone	+81-3-3265-4804
E-Mail	r_shinsa@shonankamakura.or.jp
Approval Status	Approval
Date of approval	Aug. 10, 2018

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history