UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034304 |
|---|---|
| Receipt number | 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 | 2023/01/27 14:59:53 |
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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
Incidence of infectious complications (30 days after surgery)
Key secondary outcomes
1) perioperative glycemic variability
2) inflammation-related factors
3) insulin resistance, Insulin secretory capacity
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 | Hiroya |
| Middle name | |
| Last name | Akabori |
Organization
National Hospital Organization
Higashi-Ohmi General Medical Center
Division name
Department of Surgery
Zip code
527-8505
Address
255, Gochi-cho, Higashi-Ohmi City, Shiga, Japan
TEL
0748-22-3030
hakabori@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Nagase |
Organization
Shiga University of Medical Science
Division name
Department of Comprehensive Surgery
Zip code
527-8505
Address
Tsukinowa-cho, Seta, Otsu, Shiga, Japan
TEL
0748-22-0873
Homepage URL
n12m23@belle.shiga-med.ac.jp
Sponsor or person
Institute
National Hospital Organization
Higashi-Ohmi General Medical Center
Institute
Department
Personal name
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
National Hospital Organization Higashi-Ohmi General Medical Center
Address
255, Gochi-cho, Higashi-Ohmi City, Shiga, Japan
Tel
0748223030
nagase.miki.ds@mail.hosp.go.jp
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
東近江総合医療センター (滋賀県)
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 30 | Day |
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
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039067
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
