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

Not provided0 sites230 target enrollmentStarted: TBD

Conditions

Trial Snapshot

No summary available.

•Scheduled to undergo open surgery via an upper midline abdominal incision.
•ECOG Performance Status (PS) of 0-
•Age >= 18 years.
•Body mass index (BMI) <= 35 kg/m
•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.

•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.

Sponsor

Not provided