UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012113
Receipt number R000014160
Scientific Title The effect of perioperative management clinic
Date of disclosure of the study information 2013/10/24
Last modified on 2019/04/30 00:18:23

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Basic information

Public title

The effect of perioperative management clinic

Acronym

The effect of perioperative management clinic

Scientific Title

The effect of perioperative management clinic

Scientific Title:Acronym

The effect of perioperative management clinic

Region

Japan


Condition

Condition

Surgical patient

Classification by specialty

Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate perioperative management for outpatient What Does a role in hospital management and operating room.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1.consultation rate of each department, 2. examination number, 3.number of additional inspections or tests that has been added at the clinic, 4.number of additional inspections or tests ordered the day before the surgery, 5.number of the case which the surgery was canceled the day before the surgery, 6.the influence to medical insurance with additional tests after admission.

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

Surgical cases who has done the surgery from March, 2010 to September, 2013.

Key exclusion criteria

Cases which anesthesiologists did not run anesthesia.

Target sample size

18000


Research contact person

Name of lead principal investigator

1st name Moriyama
Middle name
Last name Moriyama

Organization

Kyorin university school of medicine

Division name

Anesthesiology

Zip code

1818611

Address

6-20-2 Shinkawa Mitaka-shi, Tokyo, JAPAN

TEL

0422-47-5511

Email

mori93kumi@gmail.com


Public contact

Name of contact person

1st name Moriyama
Middle name
Last name Moriyama

Organization

Kyorin university school of medicine

Division name

Anesthesiology

Zip code

1818611

Address

6-20-2 Shinkawa Mitaka-shi, Tokyo, JAPAN

TEL

0422-47-5511

Homepage URL


Email

mori93kumi@gmail.com


Sponsor or person

Institute

Department of Anesthesiology, Kyorin university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Kyorin university school of medicine

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

Kyorin university school of medicine

Address

6-20-2 Shinkawa Mitaka-shi, Tokyo, JAPAN

Tel

0422-47-5511

Email

mori93kumi@gmail.com


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

2013 Year 10 Month 24 Day


Related information

URL releasing protocol

http://www.kyorin-u.ac.jp/univ/user/medicine/masuika/class/research

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

23243

Results

By managing preoperative patients at the perioperative management clinic, the number of cases with discontinued surgery decreased. We were able to contribute to smoother operating room management and hospital management. The annual additional inspection cost for outpatients is less than 300,000 yen, and the impact on hospital management improvement is small.

Results date posted

2019 Year 04 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

From July 2010 to the end of March 2015, an anesthesiologist was involved in all the operations performed at the Central Operating Room of the Kyorin University Medical Center Hospital.

Participant flow

Retrospective survey with electronic medical records.

Adverse events

none

Outcome measures

1. Number and consultation rate of perioperative management outpatients in each department.

2. Number of consultations.

3. Number and contents of additional examinations and other department requests at perioperative management outpatients.

4. Examination and other department request and contents added on the day before surgery, insurance score.

5. Department where surgery was discontinued and the number of cases discontinued and reasons.

6. Influence of additional examination after hospitalization on DPC.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 10 Month 25 Day

Date of IRB

2014 Year 01 Month 11 Day

Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study using medical records.


Management information

Registered date

2013 Year 10 Month 23 Day

Last modified on

2019 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014160


Research Plan
Registered date File name
2019/04/29 計画書2013-2修正20151225 (1).doc

Research case data specifications
Registered date File name
2019/04/29 CRF.xlsx

Research case data
Registered date File name
2019/04/29 手術中止率.docx