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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034304
Receipt No. R000039067
Scientific Title A prospective single-blind study of the impact of perioperative glycemic control using artificial pancreas on the prevention of postoperative complications after abdominal surgery
Date of disclosure of the study information 2018/10/05
Last modified on 2019/02/28

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Basic information
Public title A prospective single-blind study of the impact of perioperative glycemic control using artificial pancreas on the prevention of postoperative complications after abdominal surgery
Acronym A prospective study of the impact of perioperative glycemic control using artificial pancreas on the postoperative complications
Scientific Title A prospective single-blind study of the impact of perioperative glycemic control using artificial pancreas on the prevention of postoperative complications after abdominal surgery
Scientific Title:Acronym A prospective study of the impact of perioperative glycemic control using artificial pancreas on the postoperative complications
Region
Japan

Condition
Condition Gastrointestinal tumor, Hepatobiliary pancreatic tumor
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Identification of optimal glycemic concentration range during perioperative period as well as the effect of glycemic control using artificial pancreas on the postoperative complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Infectious Complication rate after surgery
Key secondary outcomes 1) perioperative glycemic variability
2) inflammation-related factors

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Glycemic control using artificial pancreas 24 hours from the start of surgery
Target blood glucose range:140-180 mg/dl
Interventions/Control_2 Glycemic control using artificial pancreas 24 hours from the start of surgery
Target blood glucose range:80-110 mg/dl
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

Not applicable
Gender Male and Female
Key inclusion criteria Performance status : 0-1
Laparotomy surgery case
Key exclusion criteria Case of serious organ injury
Patient whose life prognosis can not be expected for more than 1 month
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Akabori
Organization National Hospital Organization
Higashi-Ohmi General Medical Center
Division name Department of Surgery
Zip code
Address 255, Gochi-cho, Higashi-Ohmi City, Shiga, Japan
TEL 0748-22-3030
Email hakabori@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Nagase
Organization Shiga University of Medical Science
Division name Department of Comprehensive Surgery
Zip code
Address Tsukinowa-cho, Seta, Otsu, Shiga, Japan
TEL 0748-22-0873
Homepage URL
Email n12m23@belle.shiga-med.ac.jp

Sponsor
Institute National Hospital Organization
Higashi-Ohmi General Medical Center
Institute
Department

Funding Source
Organization self-funding
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
2018 Year 10 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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