UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021317
Receipt number R000024588
Scientific Title Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in hospitalized surgical patients with diabetes mellitus~multicenter study~(retrospective study)
Date of disclosure of the study information 2016/03/03
Last modified on 2017/03/04 12:32:06

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Basic information

Public title

Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in hospitalized surgical patients with diabetes mellitus~multicenter study~(retrospective study)

Acronym

Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in surgical patients with diabetes mellitus

Scientific Title

Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in hospitalized surgical patients with diabetes mellitus~multicenter study~(retrospective study)

Scientific Title:Acronym

Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in surgical patients with diabetes mellitus

Region

Japan


Condition

Condition

diabetes
surgery

Classification by specialty

Endocrinology and Metabolism Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

we investigated the relationship between explanatory variables (risk factors for postoperative wound sutural insufficiency and glycaemic control) and response variable (postoperative wound sutural insufficiency and mortality) in hospitalized surgical patients with diabetes mellitus.

Basic objectives2

Others

Basic objectives -Others

epidemiology of diabetic complication

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the relationship between explanatory variables (risk factors for postoperative wound sutural insufficiency and glycaemic control) and response variable (postoperative wound sutural insufficiency and mortality)

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Hospitalized surgical patients with diabetes mellitus who underwent glucose monitoring >3 times per day.

Key exclusion criteria

Patients with long durations of hospital stay (>90 days) and those who underwent very few sessions of glucose monitoring (<6 times in total) were excluded.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Soichi Takeishi

Organization

Ichinomiyanishi Hospital

Division name

Department of Endocrinology and Diabetes

Zip code


Address

1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN

TEL

0586-48-0077

Email

souichi19811225@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Soichi Takeishi

Organization

Ichinomiyanishi Hospital

Division name

Department of Endocrinology and Diabetes

Zip code


Address

1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN

TEL

0586-48-0077

Homepage URL


Email

souichi19811225@yahoo.co.jp


Sponsor or person

Institute

Ichinomiyanishi Hospital

Institute

Department

Personal name



Funding Source

Organization

nothing

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


Address


Tel


Email



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

2016 Year 03 Month 03 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

Completed

Date of protocol fixation

2016 Year 01 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We retrospectively analysed hospitalized surgical patients with diabetes mellitus who underwent glucose monitoring >3 times per day from 2014 to 2016.
We investigated the relationship between explanatory variables (risk factors for postoperative wound sutural insufficiency and glycaemic control) and response variable (postoperative wound sutural insufficiency and mortality).


Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2017 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024588


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name