UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prevalence and predictors of postoperative delirium in cancer patients
Title of the study (Brief title)	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	Yousuke Uchitomi
Organization	National Cancer Center
Division name	Innovation center for Supportive, Palliative and Psychosocial Care
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	yuchitom@ncc.go.jp

Public contact
Name of contact person	Saho Wada
Organization	National Cancer Center Hospital
Division name	Department of Psycho-Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	sawada@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021946