UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018980 |
|---|---|
| Receipt number | R000021946 |
| Scientific Title | The prevalence and predictors of postoperative delirium in cancer patients |
| Date of disclosure of the study information | 2015/09/15 |
| Last modified on | 2017/03/31 14:43:02 |
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Basic information
Public title
The prevalence and predictors of postoperative delirium in cancer patients
Acronym
A study on postoperative delirium in cancer patients
Scientific Title
The prevalence and predictors of postoperative delirium in cancer patients
Scientific Title:Acronym
A study on postoperative delirium in cancer patients
Region
| Japan |
Condition
Condition
Cancer patients who scheduled highly invasive surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Psychiatry |
| Oto-rhino-laryngology | Anesthesiology | Oral surgery |
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the prevalence of delirium after highly invasive surgery.
Basic objectives2
Others
Basic objectives -Others
To reveal the predictors of the onset and severity of delirium after highly invasive surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
the prevalence of delirium within 5 days after highly invasive surgery
Key secondary outcomes
the predictors of delirium after highly invasive surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) a diagnosis of cancer
2) patients scheduled to undergo highly invasive surgery for their cancer in participating departments
3) age greater than 20 years
Key exclusion criteria
1) being too physically ill as judged by the attending physicians or researchers
2) being too psychologically ill as judged by the attending physicians or researchers
3) inability to read or understand the informed cansent documents
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yousuke Uchitomi |
Organization
National Cancer Center
Division name
Innovation center for Supportive, Palliative and Psychosocial Care
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
yuchitom@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saho Wada |
Organization
National Cancer Center Hospital
Division name
Department of Psycho-Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
sawada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立がん研究センター中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective cohort study to reveal the prevalence and predictors of postoperative delirium in cancer patients who undergoing highly invasive surgery.
[Recruitment]
All patients who are scheduled to undergo a highly invasive surgery in Department of Esophageal Surgery, Hepatobiliary and Pancreatic Surgery, and Head and Neck oncology of National Cancer Center Hospital from October 2015, and also, all that meet the selection criteria.
[Measurement]
Patient characteristics, preoperative drugs, cognitive function (MMSE), sleeping disorder (SMH, ISI-J), anxiety (HADS), drinking history (CAGE), physical condition (PS, ASA, APACHE-II score), surgery time, anesthesia time, intraoperative amount of bleeding, intraoperative use drugs, delirium (CAM, DRS-R-98, DMSS, duration), post-operative use drugs, postoperative complications.
Management information
Registered date
| 2015 | Year | 09 | Month | 11 | Day |
Last modified on
| 2017 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021946
