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
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
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
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
