Unique ID issued by UMIN | UMIN000048170 |
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Receipt number | R000053966 |
Scientific Title | To compare the incidence of postoperative incisional hernia and SSI between absorbable and non-absorbable sutures for closure of abdominal fascia after laparotomy. |
Date of disclosure of the study information | 2022/07/01 |
Last modified on | 2022/12/27 10:33:05 |
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
The difference in postoperative outcome between absorbable and non-absorbable suture for closing abdominal fascia.
To compare the incidence of postoperative incisional hernia and SSI between absorbable and non-absorbable sutures for closure of abdominal fascia after laparotomy.
The difference in postoperative outcome between absorbable and non-absorbable suture for closing abdominal fascia.
Japan |
Malignant diseases of the digestive system requiring elective surgery with an open abdominal wound of at least 3 cm
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To compare the incidence of postoperative incisional hernia and SSI between absorbable and non-absorbable sutures for closure of abdominal fascia after laparotomy.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Incidence of surgical site infection within during hospitalization or within 1 month after surgery
Incidence of incisional hernia evaluated by abdominal CT within 2 years after the surgery
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Abdominal fascia was closed with interrupted suture with 1-0 black monofilament Nylon.
Not applicable |
Not applicable |
Male and Female
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.
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.)
200
1st name | Osamu |
Middle name | |
Last name | Itano |
International University of Health and Welfare, School of Medicine
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
286-8520
852 Hatakeda, Narita, Chiba
0476-35-5600
itano@iuhw.ac.jp
1st name | Ayako |
Middle name | |
Last name | Shimada |
International University of Health and Welfare, School of Medicine
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
286-8520
852 Hatakeda, Narita, Chiba
0476-35-5600
ashimada@g.iuhw.ac.jp
International University of Health and Welfare.
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
International University of Health and Welfare
Other
Kashiwa Kousei General Hospital
Institutional review board, International University of Health and Welfare
852 Hatakeda, Narita, Chiba
0476-35-5600
rinri_md@iuhw.ac.jp
NO
2022 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2021 | Year | 12 | Month | 17 | Day |
2022 | Year | 01 | Month | 24 | Day |
2022 | Year | 07 | Month | 01 | Day |
2024 | Year | 07 | Month | 01 | Day |
2022 | Year | 06 | Month | 26 | Day |
2022 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053966
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