UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005019 |
|---|---|
| Receipt number | R000005968 |
| Scientific Title | A randomized controlled trial for evaluation of Afternoon Colonoscopy |
| Date of disclosure of the study information | 2011/02/05 |
| Last modified on | 2018/08/14 23:50:00 |
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Basic information
Public title
A randomized controlled trial for evaluation of Afternoon Colonoscopy
Acronym
A randomized controlled trial for evaluation of Afternoon Colonoscopy
Scientific Title
A randomized controlled trial for evaluation of Afternoon Colonoscopy
Scientific Title:Acronym
A randomized controlled trial for evaluation of Afternoon Colonoscopy
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to increase the acceptability of people in the working population to colonoscopies by verifying the usefulness of scheduling colonoscopy after intake in the morning (afternoon colonoscopy: ACS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verification that the efficacy of colon irrigation in the ACS group is not inferior to the control group (non-inferiority trial)
Key secondary outcomes
Evaluation of hunger and dizziness.
Evaluation of whether or not they were able to work or do housework in the morning.
Time taken from start of polyethylene glycol lavage intake until clear.
Complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
ACS Group
Day of exam, 8:00a.m. Jelly intake (Nonfiber Wieder in Jelly Energy Drink 2 packs=360kcal).
12:00, polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.
Interventions/Control_2
Day of exam,no breakfast. 10:00a.m. polyethylene glycol lavage 2000ml taken over a 2 hr period at the hospital.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients in the Dept. of Gastroenterology of Nikko Memorial Hospital in whom colonoscopy is deemed necessary
Key exclusion criteria
History of bowel resection.
Patients with progressively worsening constipation.
Patients with a palpable abdominal mass.
Patients in whom CT or other imaging has shown colorectal cancer.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Yokoyama |
Organization
Nikko Memorial Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-5-13,Shintomityo, Muroran-shi, Hokkaido
TEL
0143-24-1331
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
045-949-7693
Homepage URL
ibusiginjp@hotmail.com
Sponsor or person
Institute
Nikko Memorial 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
日鋼記念病院（北海道） Nikko Memorial Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 05 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005968
