UMIN-CTR Clinical Trial

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

Oral cancer,Delirium

Classification by specialty

Psychiatry

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

10

Month

09

Day

Last modified on

2020

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046680