Malignant diseases of the digestive system requiring elective surgery with an open abdominal wound of at least 3 cm
Conditions
Interventions
Abdominal fascia was closed with interrupted suture with 1-0 black monofilament Nylon.
Sponsors
International University of Health and Welfare. Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Kashiwa Kousei General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following eligibility criteria will be considered eligible. 1.Patients with malignant or benign diseases of the gastrointestinal system undergoing elective laparotomy with a laparotomy wound of at least 3 cm in length. 2. Patients with a Performance Status of 0-1 are eligible for surgery. 3. Patients who are not pregnant and have no preoperative abdominal wall scar hernia. 4. Non-emergency surgery. 5. Patients without obvious preoperative peritoneal dissemination, para-aortic lymph node metastasis, or multiorgan metastasis. 6. Cases that meet the following criteria for major organ function within 30 days prior to enrollment. (a) Bone marrow function: white blood cell count>3,000/mm3, neutrophil count >1,500/mm3 (b) Renal function: Serum creatinine < 2 times the upper limit of institutional normal (ULN) 7. The patient must be at least 20 years of age at the time consent is obtained. 8. The patient himself/herself must be explained in writing and his/her written consent must be obtained.
Exclusion criteria
Exclusion 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infection within during hospitalization or within 1 month after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of incisional hernia evaluated by abdominal CT within 2 years after the surgery | — |
Countries
Japan
Contacts
Public ContactAyako Shimada
International University of Health and Welfare, School of Medicine Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Outcome results
None listed