臨床研究等提出・公開システム

Date of registration	Aug. 10, 2022
Last modified on	Aug. 15, 2022
Trial ID	jRCT2052220073

Scientific Title	A multicenter, pivotal study to demonstrate non-inferiority of Cyt-006 compared to Seprafilm in patients with primary rectal cancer and temporal colostomy underwent laparoscopic surgery
Public Title	A multicenter, pivotal study to demonstrate non-inferiority of Cyt-006 compared to Seprafilm in patients with primary rectal cancer and temporal colostomy underwent laparoscopic surgery

Contact for Scientific Queries	Name	Horii Yoshihiro
	Affiliation	Cytori Therapeutics K.K.
	Address	1-1-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-3-6860-5712
	E-mail	cyt-006-01@cytori-jp.com
Contact for Public Queries	Name	Horii Yoshihiro
	Affiliation	Cytori Therapeutics K.K.
	Address	1-1-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-3-6860-5712
	E-mail	cyt-006-01@cytori-jp.com

Recruitment status	Recruiting


Anticipated date of first enrollment		Aug. 10, 2022
Target sample size		158
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with initial and primary rectal cancer. 2) Patients with cStage 0 to cStage III. 3) Patients who are scheduled to undergo laparoscopic rectal resection and temporal colostomy. 4) Patients who are scheduled to undergo the closure of artificial anus at 8 to 48 weeks after initial surgery.
	Exclusion Criteria	Pre-operation: 1) Patients who are scheduled to undergo open abdominal surgery. 2) Patients who had a history of intraperitoneal surgery except for appendicitis, Caesarean section, or laparoscopic cholecystectomy. 3) Patients who are scheduled to remove specimens from the site other than the midline incision (except in the case of robotic surgery). 4) Patients whose performance Status >=3. 5) Patients with 35 or higher of BMI. During Operation: 1) Patients who need to undergo open abdominal surgery during laparoscopic procedure. 2) Patients who did not have a temporary colostomy. 3) Patients whose specimen was removed from a site other than the midline wound (except in the case of robotic surgery). 4) Patients who underwent colostomy at the umbilical site
	Age Minimum	20age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		primary rectal cancer
Intervention(s)		Application of the anti-adhesion barrier
Health Condition(s) Keyword		rectal cancer
Intervention(s) Keyword		anti-adhesion
Primary Outcome(s)		presence/absence of adhesion
Secondary Outcome(s)		Efficacy: Severity score of adhesion Range score of adhesion Presence/absence of ileus Success rate of pasting Safety: Adverse event, device failure or malfunction hematologic tests, blood biochemical tests vital signs

Primary Sponsor	Cytori Therapeutics K.K.

Secondary Sponsor

Name of Certified Review Board	Osaka General Medical Center Institutional Review Board
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku,Osaka-shi,Osaka, Osaka
Telephone	+81-6-6692-1201
Approval Status	Approval
Date of approval	July. 20, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Aug. 15, 2022	(this page)	Changes
1	Aug. 10, 2022	Detail

List of change history