UMIN-CTR Clinical Trial

Basic information
Public title	Clinical studies for the prevention of postoperative delirium in oral cancer
Acronym	Prevention of Oral Cancer Postoperative Delirium
Scientific Title	Clinical studies for the prevention of postoperative delirium in oral cancer
Scientific Title:Acronym	Prevention of Oral Cancer Postoperative Delirium
Region	Japan

Condition
Condition	Oral cancer,Delirium
Classification by specialty	Psychiatry Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The onset of postoperative delirium is often associated with lower quality of life and longer hospital stays for postoperative patients It has been reported. In particular, surgery for oral cancer is a lengthy operation, often involving reconstructive surgery, and the postoperative period lasts several Because bed rest is required for three days, it is highly significant to prevent the development of delirium, and proactive preoperative There is a strong demand for involvement in the prevention of this disease1-6). However, it is difficult to identify the cause of delirium, and no clear method of prevention has yet been recognized. Since January 2015, our hospital has been working with physicians and nurses from the Department of Psychiatry and Psychosomatic Medicine of the Faculty of Medicine of the University of California, Berkeley, to prevent delirium. meetings are held periodically to develop a preoperative patient risk assessment sheet, and In addition, a patient and family pamphlet has been developed to provide information on early intervention for post-operative delirium The company has been aiming to build a system that will allow for the establishment of a system for the treatment of high-risk patients with delirium. In addition, from April 2020, additional points will be added during hospitalization for dealing with high-risk delirium patients. It has come to the point where further improvement is required. In this study, we clinically examined the postoperative course of patients with oral cancer and examined the factors that contribute to the development of delirium in a backward-looking It was designed to conduct research.
Basic objectives2	Others
Basic objectives -Others	Delirium is a state of cerebral insufficiency resulting from physical or drug causes, and has a background of systemic and worsened mental status. Post-operative delirium is the most commonly experienced clinical event, and it is important to detect and deal with it at an early stage It is important to prevent the onset of the disease and the severity of the disease. Although guidelines for such postoperative delirium have been reported, there is no evidence that patients with malignant oral and maxillofacial tumors are suffering from postoperative delirium There are no clear guidelines for dealing with the In this study, we conducted a study to clarify the present situation and background factors of postoperative delirium in our hospital. Planned. In this study, the surgery was performed after January 2015 at the Tokyo Medical and Dental University Dental Hospital Review of non-personal information in medical records for oral cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After January 2015, the patient was diagnosed with oral cancer at the School of Dentistry Hospital and underwent surgery under general anesthesia. Patients who have been treated are eligible (approximately 200 cases per year, for a total of approximately 1600 cases). There will be no gender or age restrictions. The study will be conducted until December 31, 2022. For patients who develop postoperative delirium, the timing and duration of the onset of delirium will be studied, and the risk of delirium will be assessed. A comparison of the delirium-onset and delirium-free groups will be made to explore factors. The diagnosis of delirium will be made by a psychiatrist using the DSM-5 diagnostic criteria. The study will examine the presence or absence of postoperative delirium in the patients included in the study and the related tests Data and clinical findings will be used from the medical record. Background factors include age, gender, drinking history, smoking history, medication history, medical history, blood test results, surgical procedure, surgical Time, duration of anesthesia, blood loss, fever, insomnia, diarrhea, constipation, etc. will be considered.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed with oral cancer and underwent surgery under general anesthesia at our hospital between January 1, 2015, and December 31, 2022.
Key exclusion criteria	The presence or absence of post-operative delirium and related laboratory data and clinical findings are insufficient to be considered in the medical record.
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Kabasawa
Organization	Tokyo Medical and Dental University
Division name	Graduated school
Zip code	1138510
Address	Yushima Bunkyo-ku 1-5-45,Tokyo
TEL	03-5803-4647
Email	kabasawa.ocsh@tmd.ac.jp

Public contact
Name of contact person	1st name Kabasawa Middle name Last name Yuji
Organization	Tokyo Medical and Dental University
Division name	Graduated school
Zip code	1138510
Address	Yushima Bunkyo-ku 1-5-45,Tokyo
TEL	03-5803-4647
Homepage URL
Email	kabasawa.ocsh@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
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	Tokyo Medical and Dental University
Address	Yushima Bunkyo-ku 1-5-45,Tokyo
Tel	03-5803-4647
Email	kabasawa.ocsh@tmd.ac.jp

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	2020 Year 10 Month 09 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 30 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The presence or absence of post-operative delirium and related laboratory data and clinical findings are insufficient to be considered in the medical record. It has been widely reported that the onset of postoperative delirium is a significant factor in the deterioration of the patient's quality of life and prolonged hospital stay after surgery. In particular, oral cancer surgery, which is a lengthy operation and often involves reconstructive surgery and requires bed rest for several days after surgery, has high significance in preventing the development of delirium, and active involvement in the preoperative period is strongly required1-6). However, the cause of the onset of delirium is difficult to identify, and no clear method of prevention has yet been recognized. Since January 2015, our hospital has been holding regular meetings with physicians and nurses from the Department of Psychiatry and Psychosomatic Medicine of our university's School of Medicine on the prevention of delirium, creating an assessment sheet of patient risk behaviors before surgery, as well as a pamphlet for patients and their families to help them understand the importance of early intervention for postoperative delirium. The aim has been to build the system. In addition, from April 2020, additional points for dealing with high-risk patients with delirium during hospitalization will be added, and further enhancements will be required. The present study was designed to clinically examine the postoperative course of patients with oral cancer and to conduct a retrospective study of factors that contribute to the development of delirium.

Management information
Registered date	2020 Year 10 Month 09 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046680