臨床研究等提出・公開システム

Japanese

Date of registration	April. 15, 2026
Last modified on	April. 15, 2026
Trial ID	jRCT1040260008

Scientific Title	A multicenter randomized controlled trial comparing subcuticular closure versus no subcuticular closure in colorectal cancer surgery for the prevention of surgical site infection (SCISSOR Trial)
Public Title	A study comparing different wound closure methods to prevent infection after colorectal cancer surgery (Wound Closure Study)

Contact for Scientific Queries	Name	Matsuhashi Nobuhisa
	Affiliation	Department of Gastroenterological Surgery, Gifu University Hospital
	Address	1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan
	Telephone	+81-58-230-6235
	E-mail	nobuhisa517@hotmail.com
Contact for Public Queries	Name	Matsumoto Keita
	Affiliation	Department of Gastroenterological Surgery, Gifu University Hospital
	Address	1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan
	Telephone	+81-58-230-6235
	E-mail	10b6.yncc@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		April. 15, 2026
Target sample size		2000
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	factorial assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients aged >=18 years with colorectal cancer who are scheduled to undergo laparoscopic or robot-assisted resection (with a mini-laparotomy via a midline or Pfannenstiel incision). - Patients in whom wound closure can be performed according to the study protocol. - Patients who have received a full explanation of the study and have provided written informed consent.
	Exclusion Criteria	- Patients diagnosed with colorectal cancer accompanied by bowel obstruction who are judged to require emergency or urgent surgery, those requiring preoperative colonic stent placement, or those considered unsuitable for standard mechanical bowel preparation. - Patients scheduled for placement of prosthetic material (e.g., immediate mesh implantation) at the same incision site. - Patients with severe active infection or immunocompromised conditions (e.g., severe neutropenia). - Pregnant women or those with a high possibility of pregnancy. - Patients in whom standardization of the study procedures is considered difficult (e.g., inability to adhere to the protocol in emergency surgery). - Patients judged to be inappropriate for inclusion in the study by the principal investigator.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Colorectal cancer
Intervention(s)		This study evaluates wound closure techniques using a 2x2 factorial design, comparing subcutaneous suturing (with vs without) and fascial closure methods (continuous vs interrupted) in laparoscopic or robot-assisted colorectal cancer surgery.
Health Condition(s) Keyword		Colorectal cancer; Surgical site infection; Laparoscopic surgery
Intervention(s) Keyword		Subcutaneous suturing; Fascial closure; Continuous suture; Interrupted suture
Health Condition(s) Code		Prevention & Control
Intervention(s) Code		Surgery
Primary Outcome(s)		Incidence of superficial incisional surgical site infection (SSI) within 30 days postoperatively, defined according to CDC criteria, with an ASEPSIS score >20 considered as confirmed SSI.
Secondary Outcome(s)		Incidence of incisional hernia at 12 and 24 months postoperatively, assessed by abdominal CT and clinical examination.

Primary Sponsor	Gifu University Hospital

Name of Certified Review Board	Ethics Committee of Gifu University Hospital
Address	1-1 Yanagido, Gifu-shi, Gifu 501-1194, Japan, Gifu
Telephone	+81-582306000
E-Mail	rinri@t.gifu-u.ac.jp
Approval Status	Approval
Date of approval	April. 07, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none