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A multicenter randomized controlled trial of continuous abdominal wall closure using barbed sutures in abdominal open surgery.

A multicenter randomized controlled trial of continuous abdominal wall closure using barbed sutures in abdominal open surgery. - CCOG2601

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042250205
Enrollment
230
Registered
2026-03-13
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None in particular

Interventions

Abdominal wall closure with continuous barbed suture

Sponsors

Kanda Mitsuro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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) = 2500/mm3 and = 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

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.

Design outcomes

Primary

MeasureTime frame
1-year incidence of incisional hernia

Contacts

Public ContactNobuhiko Nakagawa

Department of Surgery, Nagoya University Graduate School of Medicine

nakagawa.nobuhiko.x6@f.mail.nagoya-u.ac.jp+81-52-744-2250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026