臨床研究等提出・公開システム

Date of registration	Mar. 08, 2023
Last modified on	Mar. 08, 2023
Trial ID	jRCT1032220688

Scientific Title	Evaluation of Leg Circulation During Robot-Assisted Laparoscopic Surgery
Public Title	Evaluation of Leg Circulation During Robot-Assisted Laparoscopic Surgery

Contact for Scientific Queries	Name	Yamamoto Sumii
	Affiliation	University of Tsukuba Hospital
	Address	2-1-1 Amakubo, Tsukuba, Ibaraki
	Telephone	+81-29-853-3900
	E-mail	tabasami@md.tsukuba.ac.jp
Contact for Public Queries	Name	Yamada Mariko
	Affiliation	University of Tsukuba Hospital
	Address	Tsukuba, Ibaraki
	Telephone	+81-29-853-3900
	E-mail	yamada.mariko.bp@ms.hosp.tsukuba.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 08, 2023
Actual date of first enrollment		Jan. 30, 2023
Target sample size		800
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who have given written consent to participate in the research American Society of Anaesthesiologists physical status: class I or II Patients undergoing robotic surgery under general anesthesia Elective operation
	Exclusion Criteria	body mass index > 35 kg/m2 Patients who are deemed inappropriate for inclusion in the research by the principal investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Robotic surgery
Intervention(s)		Measurement stickers will be applied to both lower legs and toes to obtain intraoperative rSO2 and PI data.
Primary Outcome(s)		Changes over time in lower leg rSO2 and toe PI during surgery

Primary Sponsor	University of Tsukuba Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Tsukuba Clinical Research and Development Organization
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-credo.adm@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Nov. 17, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none