The impact of the difference in sutures used for fascial closure on the incidence of postoperative SSI and incisional hernia in patients with gastrointestinal malignant tumor

UMIN ID: UMIN000048170

Registered date:01/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant diseases of the digestive system requiring elective surgery with an open abdominal wound of at least 3 cm
• Date of first enrollment: 2022/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Abdominal fascia was closed with interrupted suture with 1-0 black monofilament Nylon.

Outcome(s)

• Primary Outcome: Incidence of surgical site infection within during hospitalization or within 1 month after surgery
• Secondary Outcome: Incidence of incisional hernia evaluated by abdominal CT within 2 years after the surgery

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclude patients who meet any of the following criteria. 1. Patients with peritoneal dissemination, multi-organ metastasis, or para-aortic lymph node metastasis evident in the preoperative diagnosis. 2. Patients with symptomatic cardiac disease at the time of enrollment or patients with cardiac disease that is being treated. Or, patients who have a history of myocardial infarction within 1 year prior to enrollment. 3. Patients with concurrent multiple cancers or metachronous multiple cancers with a disease-free period of 5 years or less. However, patients with early-stage cancer that can be cured by treatment may be enrolled. 4. Patients with severe interstitial pneumonia or pulmonary fibrosis. 5. Patients with serious infections. 6. Patients with serious complications (renal failure, liver failure, hypertension uncontrolled by drugs, etc.)

Related Information

• Primary Sponsor: International University of Health and Welfare. Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
• Secondary Sponsor: Kashiwa Kousei General Hospital
• Source(s) of Monetary Support: International University of Health and Welfare