臨床研究等提出・公開システム

Date of registration	Nov. 02, 2022
Last modified on	Nov. 02, 2022
Trial ID	jRCT1052220113

Scientific Title	Establishment of online surgical viewing system for robot-assisted surgery.
Public Title	Establishment of remote viewing systems for robotic surgery.

Contact for Scientific Queries	Name	Mandai Masaki
	Affiliation	Kyoto university hospital
	Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
	Telephone	+81-75-751-3269
	E-mail	mandai@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Horie Akihito
	Affiliation	Kyoto university hospital
	Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
	Telephone	+81-75-751-3269
	E-mail	a_horie@kuhp.kyoto-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 02, 2021
Actual date of first enrollment		Sept. 26, 2022
Target sample size		3000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Doctors of obstetrics and gynecology who have already introduced or will introduce robotic surgery and who can give consent to the study and take an obligation of confidentiality.
	Exclusion Criteria	Doctors who cannot agree to the pledge.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Doctors of obstetrics and gynecology
Health Condition(s) Keyword		Robot assisted surgery
Health Condition(s) Code		D066231
Primary Outcome(s)		(a) whether information such as images and sounds were clearly conveyed online and the intention of the visit was sufficiently fulfilled; (b) whether the instruction and explanation were sufficiently interactive; and (c) whether an understanding of the operations and procedures necessary for the actual implementation of the surgery was obtained.
Secondary Outcome(s)		Sum of the respective scores for the five items in (a), five items in (b) and eight items in (c), rated on a five-point scale (1-5).

Primary Sponsor	Kyoto University Hospital

Secondary Sponsor

Name of Certified Review Board	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Kyoto
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 02, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none