Unique ID issued by UMIN | UMIN000040969 |
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Receipt number | R000046784 |
Scientific Title | A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED) |
Date of disclosure of the study information | 2020/09/01 |
Last modified on | 2023/01/02 10:49:54 |
A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Balsam CEED study
A prospective, multicenter study on the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Balsam CEED study
Japan |
postoperative bowel obstruction
Gastrointestinal surgery |
Others
NO
Clarifying the incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Efficacy
The incidence of postoperative bowel obstruction after laparoscopic colorectal cancer surgery using a absorbable adhesion barrier material (INTERCEED)
Observational
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Cases histologically proven as colorectal cancer
2) Cases without metastatic lesions and/or invasion to the adjacent organs
3) Cases performed laparoscopic surgery
4) Cases performed curative surgery
5) Cases using INTERCEED as an adhesion barrier material
6) Patients between the ages of 20 and 80
7) Patients with ECOG Performance states 0-1
8) Cases enrolled within 3 days of surgery
9) Patients with all of the following on examination within 1 month prior to enrollment, with preserved major organ function and no suspected active infection
-White blood cell count: 3,000/mm3 or higher
-Platelet count: 75,000/mm3 or higher
-Hemoglobin: 8.0 g/dl or higher
-Serum AST and ALT: 2.5 times or less than the upper limit of the institutional reference value
-Serum total bilirubin: less than 1.5 mg/dl
-Serum creatinine: 1.5 mg/dl or less
1) Patients for whom Interseed is contraindicated
2) Patients who received previous abdominal surgery (except for appendectomy performed more than 5 years ago). Anterior approach to inguinal hernia surgery is acceptable.
3) Patients deemed ineligible to participate in this study bytheir physicians
4) Patients with cancer recurrence within 2 years will be excluded at the time of statistical analysis.
5) Cases cannot followed for 2 years will be excluded a the time of statistical analysis.
400
1st name | Takeshi |
Middle name | |
Last name | Yamada |
Nippon medical school
Department of Gastrointestinal and Hepatp-Biliary-Pancreatic Surgery
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo
0338222131
y-tak@nms.ac.jp
1st name | Hiromichi |
Middle name | |
Last name | Sonoda |
Nippon medical school
Department of Gastrointestinal and Hepatp-Biliary-Pancreatic Surgery
113-8603
1-1-5, Sendagi, Bunkyo-ku, Tokyo
0338222131
hiromichi-sonoda@nms.ac.jp
Nippon medical school
Self funding
Self funding
Ethical committee at Nippon medical school
1-1-5, Sendagi, Bunkyo-ku, Tokyo
0338222131
nms_fuzokurinri@nms.ac.jp
NO
2020 | Year | 09 | Month | 01 | Day |
Unpublished
26
No longer recruiting
2020 | Year | 06 | Month | 12 | Day |
2020 | Year | 06 | Month | 12 | Day |
2020 | Year | 09 | Month | 01 | Day |
2024 | Year | 08 | Month | 31 | Day |
We will follow up on the occurrence of bowel obstruction up to two years after laparoscopic colorectal cancer surgery by physical examination and abdominal computed tomography.
2020 | Year | 07 | Month | 01 | Day |
2023 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046784
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