Unique ID issued by UMIN | UMIN000027967 |
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Receipt number | R000031985 |
Scientific Title | Efficacy of TJ-45 for postoperative delirium in elderly patients undergoing gastroenterological cancer surgery |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2017/11/08 21:16:49 |
Efficacy of TJ-45 for postoperative delirium in elderly patients undergoing gastroenterological cancer surgery
Prevention of postoperative delirium in elderly patients
Efficacy of TJ-45 for postoperative delirium in elderly patients undergoing gastroenterological cancer surgery
Prevention of postoperative delirium in elderly patients
Japan |
Gastroenterological cancer
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To clarify the efficacy of TJ-45 for postoperative delirium
Efficacy
Confirmatory
Phase II
Incidencnce of postoperative delirium
Postoperative complications, duration of postoperative hospital stay, outcome at discharge, changes G8 score and cognitive function, nutrtional status, prognosis
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
2
Treatment
Medicine |
No treatment
TJ-45
75 | years-old | <= |
Not applicable |
Male and Female
1. 75 years old or older patients with gastroenterological cancer
2. elective surgery patients
3. scheduled for laparotomy or laparoscopic surgery
4. PS 0-2
5. adequate organ function
1. unable to eat foods
2. scheduled for thoracotomy or tholacoscopic surgery
3. double cancer
4. Antipsychotics, antidepressant, or narcotics medication within 6 months
5. dementia
290
1st name | |
Middle name | |
Last name | Masaaki Motoori |
Osaka General Medical Center
Surgery
3-1-56 Bandai-Higashi, Sumiyoshi-Ku, Osaka, Japan
06-6692-1201
mmotoori@gh.opho.jp
1st name | |
Middle name | |
Last name | Masaaki Motoori |
Osaka General Medical Center
Surgery
3-1-56 Bandai-Higashi, Sumiyoshi-Ku, Osaka, Japan
06-6692-1201
mmotoori@gh.opho.jp
Clinical Study Group of Osaka University on Section of Risk Management
Clinical Study Group of Osaka University on Section of Risk Management
Self funding
NO
2017 | Year | 09 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 20 | Day |
2017 | Year | 11 | Month | 08 | Day |
2017 | Year | 06 | Month | 28 | Day |
2017 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031985
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