臨床研究等提出・公開システム

Scientific Title	Clinical applications of robotic telesurgical support
Public Title	Clinical applications of robotic telesurgical suppor

Contact for Scientific Queries	Name	Morohashi Hajime
	Affiliation	Gastroenterological Surgery, Hirosaki University Hospital
	Address	5 Zaifucho Hirosaki Aomori
	Telephone	+81-172-39-5079
	E-mail	hm2002@hirosaki-u.ac.jp
Contact for Public Queries	Name	Morohashi Hajime
	Affiliation	Gastroenterological Surgery, Hirosaki University Hospital
	Address	5 Zaifucho Hirosaki Aomori
	Telephone	+81-172-39-5079
	E-mail	hm2002@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 27, 2024
Actual date of first enrollment
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with gastrointestinal cancer using hinotori 2) Performance Status (PS 0 or 1) 3) Age of 20 over years 4) Written informed consent
	Exclusion Criteria	1) Difficulty of curative resection 2) Difficulty in pneumoperitoneum (Advanced emphysema, severe heart failure, angle closure glaucoma) 3) Severe cardiovascular disease (Cardiac infarction, unstable Angina pectoris, heart failure, stroke, pulmonary embolism, other thrombosis, etc.) within 6 months before registration 4) Sever complication ((Interstitial pneumonitis, pulmonary neuritis, liver failure, active infection, etc.)
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Digestive cancer
Intervention(s)		Telesurgcal support via communication lines from a remote location for patients with digestive cancer using hinotori.
Health Condition(s) Keyword		Telesurgery, robot
Intervention(s) Keyword		Telesurgery, Telesurgical support
Health Condition(s) Code		D004066
Intervention(s) Code		D000082222
Primary Outcome(s)		Completion of telesurgical support
Secondary Outcome(s)		Conversion rate, operation time, hemorrhage volum, intraoperative complications, Postoperative complications

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hirosaki University General Certified Review Board
Address	1 Bunkyocho, Hirosaki, Aomori
Telephone	+81-172-39-5362
E-Mail	crb-hirosaki@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 25, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history