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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027967
Receipt No. 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

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Basic information
Public title Efficacy of TJ-45 for postoperative delirium in elderly patients undergoing gastroenterological cancer surgery
Acronym Prevention of postoperative delirium in elderly patients
Scientific Title Efficacy of TJ-45 for postoperative delirium in elderly patients undergoing gastroenterological cancer surgery
Scientific Title:Acronym Prevention of postoperative delirium in elderly patients
Region
Japan

Condition
Condition Gastroenterological cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of TJ-45 for postoperative delirium
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidencnce of postoperative delirium
Key secondary outcomes Postoperative complications, duration of postoperative hospital stay, outcome at discharge, changes G8 score and cognitive function, nutrtional status, prognosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 No treatment
Interventions/Control_2 TJ-45
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 290

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Motoori
Organization Osaka General Medical Center
Division name Surgery
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-Ku, Osaka, Japan
TEL 06-6692-1201
Email mmotoori@gh.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Motoori
Organization Osaka General Medical Center
Division name Surgery
Zip code
Address 3-1-56 Bandai-Higashi, Sumiyoshi-Ku, Osaka, Japan
TEL 06-6692-1201
Homepage URL
Email mmotoori@gh.opho.jp

Sponsor
Institute Clinical Study Group of Osaka University on Section of Risk Management
Institute
Department

Funding Source
Organization Clinical Study Group of Osaka University on Section of Risk Management
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2017 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031985

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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