UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041558
Receipt number R000047453
Scientific Title Impact of glycemic control by artificial pancreas on perioperative management such as surgical site infection: single center, prospective cohort observational study
Date of disclosure of the study information 2020/08/26
Last modified on 2023/03/13 08:46:52

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Basic information

Public title

Impact of glycemic control by artificial pancreas on perioperative management such as surgical site infection: single center, prospective cohort observational study

Acronym

Impact of glycemic control by artificial pancreas on perioperative management

Scientific Title

Impact of glycemic control by artificial pancreas on perioperative management such as surgical site infection: single center, prospective cohort observational study

Scientific Title:Acronym

Impact of glycemic control by artificial pancreas on perioperative management

Region

Japan


Condition

Condition

Patients who were received surgical operation including esophagectomy, hepatectomy and pancreatectomy, with artificial pancreas management

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine whether using artificial pancreas reduce postoperative surgical site infection (SSI), hospital stay, and other postoperative complications.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate incidence of SSI and length of hospital stay and other postoperative complications.

Key secondary outcomes

Incidence of cardiac events, reoperation, delirium, and other complications.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients undergoing elective esophagectomy, hepatectomy and pancreatectomy.
2) Patients aged over 18.
3) Patients using artificial pancreas.

Key exclusion criteria

1) Patients who require emergency surgery
2) Patients who were judged to be inappropriate as subjects by the study investigators.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yoshihito
Middle name
Last name Fujita

Organization

Aichi Medical University

Division name

anesthesiology and general intensive care unit

Zip code

480-1195

Address

1-1 Karimata Yazako Nagakute-city Aichi-prefecture Japan

TEL

0561623311

Email

fujita.yoshihito.823@mail.aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Yoshihito
Middle name
Last name Fujita

Organization

Aichi Medical University

Division name

Anesthesiology and general intensive care unit

Zip code

480-1195

Address

1-1 Karimata Yazako Nagakute-city Aichi-prefecture Japan

TEL

0561623311

Homepage URL


Email

fujita.yoshihito.823@mail.aichi-med-u.ac.jp


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Aichi Medical University

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

Aichi Medical University IRB

Address

1-1 Karimata Yazako Nagakute-city Aichi-prefecture Japan

Tel

0561623311

Email

aichi-med@esct.bvits.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

2020 Year 08 Month 26 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

205

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

Non.

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2020 Year 08 Month 26 Day

Date of IRB

2020 Year 08 Month 26 Day

Anticipated trial start date

2020 Year 08 Month 26 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry

2022 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

single center, prospective cohort observational study


Management information

Registered date

2020 Year 08 Month 26 Day

Last modified on

2023 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047453


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name