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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009103
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Machida Municipal Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010632

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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