臨床研究等提出・公開システム

Date of registration	Mar. 13, 2026
Last modified on	Mar. 13, 2026
Trial ID	jRCT1042250205

Scientific Title	A multicenter randomized controlled trial of continuous abdominal wall closure using barbed sutures in abdominal open surgery. (CCOG2601)
Public Title	A multicenter randomized controlled trial of continuous abdominal wall closure using barbed sutures in abdominal open surgery. (CCOG2601)

Contact for Scientific Queries	Name	Kanda Mitsuro
	Affiliation	Department of Surgery, Nagoya University Graduate School of Medicine
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-744-2250
	E-mail	kanda.mitsuro.v5@f.mail.nagoya-u.ac.jp
Contact for Public Queries	Name	Nakagawa Nobuhiko
	Affiliation	Department of Surgery, Nagoya University Graduate School of Medicine
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-744-2250
	E-mail	nakagawa.nobuhiko.x6@f.mail.nagoya-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 13, 2026
Target sample size		230
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Scheduled to undergo open surgery via an upper midline abdominal incision. ECOG Performance Status (PS) of 0-1. Age >= 18 years. Body mass index (BMI) <= 35 kg/m2. Adequate function of major organs (bone marrow, liver, kidney, lung, etc.), meeting all of the following: A) White blood cell count: >= 2500/mm3 and <= 14000/mm3 B) Hemoglobin: >= 9.0 g/dL C) Platelet count: >= 100000/mm3 D) Total bilirubin: <= 2.0 mg/dL E) Creatinine: <= 2.0 mg/dL Expected to survive for at least 1 year after surgery. Has sufficient decision-making capacity to understand the study and has provided written informed consent personally.
	Exclusion Criteria	Patients scheduled to undergo laparoscopic surgery or robot-assisted surgery. Patients undergoing laparotomy via an approach other than a midline incision. Patients expected to have an incision length > 40 cm. Patients with a history of upper abdominal surgery performed via laparotomy. Patients undergoing emergency surgery. Patients who are considered likely to require arterial reconstruction (e.g., superior mesenteric artery, common hepatic artery, celiac artery). Patients with severe ischemic heart disease. Patients with liver cirrhosis or active hepatitis. Patients with chronic respiratory disease requiring treatment (e.g., interstitial pneumonia, pulmonary fibrosis, COPD). Patients on hemodialysis for chronic renal failure. Patients receiving continuous systemic corticosteroids and/or immunosuppressants. Patients with severe drug allergies. Patients with psychotic disorders or psychiatric symptoms deemed to make study participation difficult. Patients with drug or alcohol dependence. Patients judged by the investigator to be inappropriate for participation in this trial.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		None in particular
Intervention(s)		Abdominal wall closure with continuous barbed suture
Primary Outcome(s)		1-year incidence of incisional hernia

Name of Certified Review Board	Nagoya University Certified Review Board
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 05, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none