UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009103 |
|---|---|
| Receipt number | R000010632 |
| Scientific Title | A prospective evaluation of usefulness of combination of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by colonoscopy. |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2014/10/13 12:55:42 |
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Basic information
Public title
A prospective evaluation of usefulness of combination of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by colonoscopy.
Acronym
A prospective evaluation of usefulness of combination of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by colonoscopy.
Scientific Title
A prospective evaluation of usefulness of combination of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by colonoscopy.
Scientific Title:Acronym
A prospective evaluation of usefulness of combination of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by colonoscopy.
Region
| Japan |
Condition
Condition
surveillance colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the usefulness of water immersion and carbon dioxide insufflation for relieving abdominal discomfort caused by surveillance colonoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of abdominal discomfort on a scale of 0 to 3 at the time of cecal intubation,just after colonoscopy, 30 and 60 minutes after colonoscopy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Only insufflation with air
Interventions/Control_2
Combination of water immersion and insufflation with carbon dioxide
Interventions/Control_3
Only insufflation with carbon dioxide
Interventions/Control_4
Combination of water immersion and insufflation with air
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients without abdominal synptoms who will have surveillance colonoscopy.
Key exclusion criteria
The patients who do upper gastrointestinal endoscopy on the same day.
The patients after abdominal operations, except for appendectomy and laparoscopic cholecystectomy.
The patients with inflammatory bowel disease, advanced cancer and multiple colon diverticula.
The patients with gastrointestinal bleeding.
The patient with inadequate bowel preparation.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi izumi |
Organization
Machida Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahimachi, Machida-shi, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Machida Municipal Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Machida Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 13 | 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
| 2012 | Year | 10 | Month | 12 | Day |
Last modified on
| 2014 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010632
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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