臨床研究等提出・公開システム

Scientific Title	Surgical outcomes of robot-assisted super-low anterior resection or robot-assisted rectal resection with transanal anastomosis: a retrospective cohort study (ROSEMARY study)
Public Title	Surgical outcomes of robot-assisted super-low anterior resection or robot-assisted rectectomy with transanal anastomosis: a retrospective cohort study (ROSEMARY study)

Contact for Scientific Queries	Name	Takemasa Ichiro
	Affiliation	Department of Surgery, Surgical Oncology and Science Sapporo Medical University
	Address	S1W16, Chuo-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-611-2111
	E-mail	itakemasa@sapmed.ac.jp
Contact for Public Queries	Name	Miyo Masaaki
	Affiliation	Department of Surgery, Surgical Oncology and Science Sapporo Medical University
	Address	S1W16, Chuo-ku, Sapporo, Hokkaido, Japan
	Telephone	+81-11-611-2111
	E-mail	mmiyo@sapmed.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 02, 2022
Actual date of first enrollment
Target sample size		1000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients who underwent R-sLAR or robot-assisted rectal resection with transanal anastomosis (R-ISR or R-TaTME) between January 1, 2020 and December 31, 2021 2) Patients histologically diagnosed with rectal cancer (pap, tub, por, muc, sig, med, or asc)
	Exclusion Criteria	1) Patients who indicated their intention to refuse to use the data for this study 2) Other patients who are judged to be inappropriate by the principal investigator or co-investigator
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		rectal cancer
Intervention(s)
Health Condition(s) Keyword		rectal cancer
Intervention(s) Keyword
Health Condition(s) Code		D012004
Intervention(s) Code
Primary Outcome(s)		Total surgery time and console time Intraoperative bleeding Proportion of transition to laparotomy Occurrence rate of intraoperative adverse events Postoperative hospital stay Severity of residual cancer Rate of all complications within 30 days after surgery Rehospitalization rate within 30 days after surgery Reoperation rate within 30 days after surgery Death rate at discharge 30 day postoperative mortality rate 90 day postoperative mortality rate
Secondary Outcome(s)

Primary Sponsor	Ichiro Takemasa

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Intuitive Surgical Sarl
Secondary Sponsor	Not applicable

Name of Certified Review Board	Institutional review board of Sapporo Medical University School of Medicine Hospital
Address	291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Hokkaido
Telephone	+81-11-611-2111
E-Mail	ji-rskk@sapmed.ac.jp
Approval Status	Approval
Date of approval	Oct. 13, 2022

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