UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027967
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

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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 or person

Institute

Clinical Study Group of Osaka University on Section of Risk Management

Institute

Department

Personal name



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

Value
https://center6.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