Unique ID issued by UMIN | UMIN000000648 |
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Receipt number | R000000782 |
Scientific Title | A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer |
Date of disclosure of the study information | 2007/04/01 |
Last modified on | 2021/11/15 22:17:58 |
A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer (OGSG 0507)
OGSG 0507
A phase III study on the anti-SSI effects of preoperative immunonutrition for patients who undergo total gastrectomy for gastric cancer
OGSG 0507
Japan |
Patients who undergo total gastrectomy for gastric cancer
Medicine in general | Gastroenterology | Infectious disease |
Gastrointestinal surgery |
Others
NO
Evaluation of the effects of preoperative immunonutrient(Impact) for the patients who undergo total gastrectomy for gastric cancer
Efficacy
primary endpoint
incidence of SSI
secondary endpoints
incidence of infection
postoperative CRP
postoperative complications
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine | Food |
Group A: Inpact + free food intake
Inpact 1000ml/day during preoperative 5 days and
free food intake
remorize about Inpact intake and administration of
antibiotics
Group B: Free food intake
without any administration of Inpact
memorize the administration of antibiotics
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. gastric cancer confirmed by endoscopy and histology
2. required the total gastrectomy
3. with a scheduled day for surgical operation
4. patient who can take the immunonutrient for preoperative 5 days
5. without severe weight loss (within -10%)
6. with sufficient function on the liver, kidney and bone marrow
7. age 20<= and 80>=
8. written informed consent
1. with other severe diseases
2. with some obstruction and/or bleeding on digestive tract
3. with active infectious diseases
4. patient who needs emergent operation
5. patient under some organ failure
6. uncontrolled DM or insulin controlled DM
7. without agreement of doctor
240
1st name | |
Middle name | |
Last name | Tsujinaka Toshimasa |
National Hospital Organization
Osaka Medical Center
Dpt.Surgery
2-1-14,Houenzaka,Chuou-ku,Osaka,569-0801
1st name | |
Middle name | |
Last name | Furukawa Hiroshi |
Sakai City Hospital
Director
1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
0722-21-1700
hfuruk@pop07.oden.ne.jp
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Osaka Clinical Study Supporting Organization
Self funding
NO
2007 | Year | 04 | Month | 01 | Day |
https://academic.oup.com/bjs/article/99/5/621/6141011
Published
https://academic.oup.com/bjs/article/99/5/621/6141011
244
Surgical-site infections (SSI) occurred in 27 patients in the immunonutrition group and 23 patients in the control group (risk ratio (RR) 1.09, 95% confidence interval 0.66 to 1.78).
2021 | Year | 11 | Month | 14 | Day |
2012 | Year | 02 | Month | 24 | Day |
patients with primary gastric cancer, fit for total gastrectomy
Of 244 randomized patients, 117 were allocated to the control group and 127 received immunonutrition.
.
The primary endpoint was the incidence of surgical-site infection (SSI). Secondary endpoints were rates of infectious complications, overall postoperative morbidity, and C-reactive protein (CRP) levels on 3-4 days after surgery.
Completed
2005 | Year | 10 | Month | 18 | Day |
2005 | Year | 11 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2007 | Year | 03 | Month | 22 | Day |
2021 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000782
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