UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012205 |
|---|---|
| Receipt number | R000014272 |
| Scientific Title | Efficacy of spinal correction in patients with severe spinal kyphotic deformity for gastroesophageal reflux disease |
| Date of disclosure of the study information | 2013/11/03 |
| Last modified on | 2013/11/03 08:31:07 |
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Basic information
Public title
Efficacy of spinal correction in patients with severe spinal kyphotic deformity for gastroesophageal reflux disease
Acronym
Spinal deformity and GERD
Scientific Title
Efficacy of spinal correction in patients with severe spinal kyphotic deformity for gastroesophageal reflux disease
Scientific Title:Acronym
Spinal deformity and GERD
Region
| Japan |
Condition
Condition
spinal kyphotic deformity
GERD
Classification by specialty
| Gastroenterology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify what is characteristic of acid reflux to esophagus in kyphotic patients and to investigate whether endoscopic GERD, acid reflux-related symptom and acid reflux improve after spiral correction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of spinal correction in patients with severe spinal kyphotic deformity for gastroesophageal reflux disease
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
| Maneuver |
Interventions/Control_1
Spinal correction
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
kyphosis patients of higher 20 years old with a Cobb angle of greater than 40'
Key exclusion criteria
1. Patients don't accept to entry this study
2. Past history of surgical resection of stomach or esophagus.
3. Less than 20 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL
81-53-435-2261
mitsu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsushige Sugimoto |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, JAPAN
TEL
81-53-435-2261
Homepage URL
mitsu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
A grant-in-aid from the Ministry of Education, Culture, Sports, Science and Technology of Japan (22790640 and 24590912).
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 11 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | 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
| 2013 | Year | 11 | Month | 03 | Day |
Last modified on
| 2013 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014272
