UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Glycaemic variability are associated with postoperative wound sutural insufficiency and mortality in hospitalized surgical patients with diabetes mellitus~multicenter study~(retrospective study)
Title of the study (Brief title)	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	Soichi Takeishi
Organization	Ichinomiyanishi Hospital
Division name	Department of Endocrinology and Diabetes
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	Soichi Takeishi
Organization	Ichinomiyanishi Hospital
Division name	Department of Endocrinology and Diabetes
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586-48-0077
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	Ichinomiyanishi Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024588