UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023895 |
|---|---|
| Receipt number | R000027412 |
| Scientific Title | A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/03/21 17:18:54 |
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Basic information
Public title
A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Acronym
Split-dose vs morning-only dose preparation for afternoon colonoscopy
Scientific Title
A randomized controlled study evaluating the efficacy and acceptability of split-dose compared with morning-only dose reduced-volume polyethylene glycol electrolyte solution for afternoon colonoscopy
Scientific Title:Acronym
Split-dose vs morning-only dose preparation for afternoon colonoscopy
Region
| Japan |
Condition
Condition
Inpatient who have a plan to be performed colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the efficacy of the standard regimen compared to the alternate one; repeat to take 500 ml of PEG-ASC after 250 clear liquid three times.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was successful bowel cleansing.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The standard regimen of PEG-ASC for afternoon colonoscopy in Japan is to take the first liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid, and to take 500 ml of PEG-ASC after 250 ml of clear water from 9 AM.
Interventions/Control_2
The split dose regimen;
The day before colonoscopy; To take the one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 4 PM.
The day of colonoscopy; To take one liter of PEG-ASC (250ml every 15 min) after 500 ml of clear liquid from 9:45 AM.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients provided written, informed consent. All consecutive inpatients of both sexes aged 20 years and older who were scheduled for mainly therapeutic colonoscopy such as polypectomy, endoscopic mucosal resection, and endoscopic submucosal dissection at ACCH.
Key exclusion criteria
Patients with the following clinical features were excluded: significant cardiac, renal, hepatic, or metabolic co-morbidities, ascites, severe constipation (<2 bowel movements per week), known allergy to PEG-ELS, history of gastric stapling or bypass procedure, or history of prior colonic or rectal surgery. Patients were excluded if there was a suspected diagnosis of intestinal obstruction because of advanced colorectal cancer.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tajika |
Organization
Aichi Cancer Center Hospital
Division name
Endoscopy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL
052-762-6111
mtajika@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Tajika |
Organization
Aichi Cancer Center Hospital
Division name
Endoscopy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL
052-762-6111
Homepage URL
mtajika@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd., Tokyo, Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Japan
Tel
052-762-6111
irb@aichi-cc.jp
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
| 2016 | Year | 10 | Month | 01 | 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
| 2016 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027412
