UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030725 |
|---|---|
| Receipt number | R000035083 |
| Scientific Title | Randomized study evaluating antiperistaltic effect of mildly cold water sprayed onto the gastrointestinal mucosa for colonoscopy |
| Date of disclosure of the study information | 2018/01/08 |
| Last modified on | 2018/01/08 16:47:52 |
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Basic information
Public title
Randomized study evaluating antiperistaltic effect of mildly cold water sprayed onto the gastrointestinal mucosa for colonoscopy
Acronym
Randomized study evaluating antiperistaltic effect of mildly cold water sprayed onto the gastrointestinal mucosa for colonoscopy
Scientific Title
Randomized study evaluating antiperistaltic effect of mildly cold water sprayed onto the gastrointestinal mucosa for colonoscopy
Scientific Title:Acronym
Randomized study evaluating antiperistaltic effect of mildly cold water sprayed onto the gastrointestinal mucosa for colonoscopy
Region
| Japan |
Condition
Condition
Gastrointestinal peristalsis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this RCT is to evaluate the antiperistaltic effect of mildly cold water in endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The peristalsis-suppressing effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Mildly cold water
Interventions/Control_2
Room temperature water
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
Patients who have agreement to our study and undergo endoscopy using mildly cold water randomly
Key exclusion criteria
Patient who is not able to undergo endoscopy by other organs disorder, patient after gastrointestinal surgery, patients with inflammatory bowel disease, patients with familial adenomatous polyposis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Okuda |
Organization
Fukuchiyama City Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL
+81-773-22-2101
okudatti@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Inoue |
Organization
Fukuchiyama City Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL
+81-773-22-2101
Homepage URL
keninoue71@koto.kpu-m.ac.jp
Sponsor or person
Institute
Fukuchiyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation For Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 01 | Month | 08 | 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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | 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
| 2018 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035083
