UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018801 |
|---|---|
| Receipt number | R000021753 |
| Scientific Title | Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2016/08/25 20:54:39 |
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Basic information
Public title
Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Acronym
Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Scientific Title
Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Scientific Title:Acronym
Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the efficacy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical recurrence rate in one week after the colonoscopy
Key secondary outcomes
Clinical recurrence rate in eight week after the colonoscopy
Transition of vital sign and symptom before and after the colonoscopy
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Colonosocopy using carbon dioxide insufflation
Interventions/Control_2
Colonosocopy using air insufflation
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with clinical remission
Key exclusion criteria
- Post history of colectomy
- Patients with total parenteral nutrition(TPN)
- Patients with chronic obstructive pulmonary disease(COPD)
- Patients with serious heart disease
- Patients who are planing to perform colonoscopy with intravenous anesthesia
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Hiyama |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Therapeuitcs for Inflammatory Bowel Diseasesd Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
s-hiyama@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Graduate School of Medicine,
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Graduate School of Medicine,
Department of Gastroenterology and Hepatology
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
14372
Org. issuing International ID_1
Ethics Committee of Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 27 | 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
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2016 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021753
