UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031234 |
|---|---|
| Receipt number | R000035664 |
| Scientific Title | Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy |
| Date of disclosure of the study information | 2018/02/09 |
| Last modified on | 2018/02/09 19:19:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy
Acronym
Castor oil study
Scientific Title
Multicenter feasibility study of bowel preparation with castor oil for colon capsule endoscopy
Scientific Title:Acronym
Castor oil study
Region
| Japan |
Condition
Condition
Colorectal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The extensive use of laxatives and incomplete excretion rates are problematic for colorectal cancer screening using colon capsule endoscopy (CCE). The aim of this study was to determine the effectiveness of castor oil as a booster.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Capsule excretion rates within its battery life
Key secondary outcomes
Sensitivity and specificity of detection rates of colorecatl polyps
Colorectal cleansing level
Adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 17 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Examinees suspicious of colorectal diseases
Key exclusion criteria
Examinees with swallowing disturbance
Examinees with allergy to drugs used in this study
Documented or possible pregnant women
Examinees who will undergo MRI within 2 weeks after capsule endoscopy
Examinees with small or large bowel obstruction
Examinees with documented stenosing colorectal cancer
Target sample size
319
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Ohmiya |
Organization
Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Department of Gastroenterology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Internal Medicine, Masuko Memorial Hospital, Nagoya,
Department of Gastroenterology, Kyoto Kujo Hospital, Kyoto,
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya,
Department of Innovative Interventional Endoscopy Research, the Jikei University School of Medicine, Tokyo, Japan
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
藤田保健衛生大学病院（愛知県）、増子記念病院（愛知県）、京都九条病院（京都府）、名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 09 | 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
Capsule excretion rates within its battery life in the groups with and without castor oil were 97% and 81%, respectively.
The overall adequate cleansing level ratios with and without castor oil were 74% and 83%, respectively.
Per-examinee sensitivity for polyps>6 mm with and without castor oil was 83% and 85%, respectively, with specificities of 80% and 78%, respectively.
There were no complications associated with castor oil and colon capsule endoscopy including bleeding, perforation, severe abdominal pain, vomiting, aspiration pneumonia, and anaphylaxis.
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 16 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 20 | Day |
Other
Other related information
Bowel preparation(magnesium Citrate before the examination day and Moviprep on the examination day) with and without castor oil.
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2018 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035664
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
