UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021493 |
|---|---|
| Receipt number | 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 20:43:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
watadani@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024789
