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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031234
Receipt No. 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

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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
Email 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
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Department of Gastroenterology
Institute
Department

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
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 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
URL(English) https://upload.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


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