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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023204
Receipt No. R000026749
Scientific Title Clinical study of motility of the stomach in the patients with gastric fistula; assessment of motility of the stomach measured by the pressure transducer from gastric fistula.
Date of disclosure of the study information 2016/08/15
Last modified on 2019/07/25

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Basic information
Public title Clinical study of motility of the stomach in the patients with gastric fistula;
assessment of motility of the stomach measured by the pressure transducer from gastric fistula.
Acronym Clinical study of motility of the stomach in the patients with gastric fistula.
Scientific Title Clinical study of motility of the stomach in the patients with gastric fistula;
assessment of motility of the stomach measured by the pressure transducer from gastric fistula.
Scientific Title:Acronym Clinical study of motility of the stomach in the patients with gastric fistula.
Region
Japan

Condition
Condition The patients with gastric fistula
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of motility of the stomach measured from gastric fistula.
The relationship between motility of the
stomach and survival rate is going to be
estimated.
Motility of the stomach measured from
gastric fistula is going to be compared
with the data of electrogastrography
Basic objectives2 Others
Basic objectives -Others The relationship age, nutritional status, liver function, kidney function, and
presence or absence of diabetes mellitus
and survival rate is going to be
estimated. .
Comparison with motility of the stomach
measured and the data of
electrogastrography
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of motility of the stomach
measured from gastric fistula and electrical activity of the stomach.
Key secondary outcomes Age, nutritional status, liver function, kidney function, presence or absence of
diabetes mellitus before the gastrostomy


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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient that gastrostomy was performed
Key exclusion criteria Refusal of the patients or the family
Target sample size 50

Research contact person
Name of lead principal investigator
1st name FUMIHIKO
Middle name
Last name KINEKAWA
Organization The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Division name Gastroenterology
Zip code 762-0007
Address 3-5-28, Muromachi, Sakaide City, Kagawa Prefecture, Japan.
TEL 0877-46-1011
Email kine@kaisei.or.jp

Public contact
Name of contact person
1st name FUMIHIKO
Middle name
Last name KINEKAWA
Organization The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Division name Gastroenterology
Zip code 762-0007
Address 3-5-28, Muromachi, Sakaide City, Kagawa Prefecture, Japan.
TEL 0877-46-1011
Homepage URL http://www.kaisei.or.jp/
Email kine@kaisei.or.jp

Sponsor
Institute The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Gastroenterology
Institute
Department

Funding Source
Organization Department of Gastroenterology & Neurology,Faculty of Medicine,Kagawa University

Department of Systems Design Engineering,
Faculty of Engineering Science,
Akita University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Certified Review Board
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan Okayama
Tel 086-235-6503
Email ouh-crrb@adm.okayama-u.ac.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 社会医療法人財団大樹会総合病院回生病院(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 15 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 22
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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 15 Day
Date of IRB
2019 Year 03 Month 29 Day
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information Intragastric pressure and electrical
activity seven days after gastrostomy.
Age, nutritional state, liver function, kidney function, and The relationship age, nutritional status, liver function, kidney function, and presence or absence of diabetes mellitus.
Results described above and survival rate is going to be estimated.

Management information
Registered date
2016 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026749

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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