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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021493
Receipt No. R000024789
Scientific Title Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Date of disclosure of the study information 2016/04/01
Last modified on 2018/10/02

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Basic information
Public title Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Acronym Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Scientific Title Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Scientific Title:Acronym Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Region
Japan

Condition
Condition Symptomatic Gallstone Disease
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validation of the Japanese Version of Gastrointestinal Quality of Life Index(GIQLI)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of patients with symptomatic gallstones before and after laparoscopic cholecystectomy by using Japanese version of the GIQLI to assess responsiveness and internal consistency.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Questionnaire stuy
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

Not applicable
Gender Male and Female
Key inclusion criteria Symptomatic gallstone disease
Key exclusion criteria Emergent surgery
Gallbladder cancer
Other disease accompanied with abdominal pain
Severe comorbidities
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ohge
Organization Hiroshima University Hospital
Division name Department of Infectious Diseases
Zip code
Address 1-2-3 Kasumi Minamiku Hiroshima
TEL 082-257-5216
Email ohge@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Watadani
Organization Hiroshima University
Division name Department of Surgery
Zip code
Address 1-2-3 Kasumi Minamiku Hiroshima
TEL 082-257-5216
Homepage URL
Email watadani@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Tsumura Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 10 Month 02 Day

Other
Other related information The study will start from April, 2016.

Management information
Registered date
2016 Year 03 Month 16 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024789

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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