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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009279
Receipt No. R000010901
Scientific Title Efficacy of automated carbon dioxide insufflation in CT colonography
Date of disclosure of the study information 2012/11/07
Last modified on 2014/08/15

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Basic information
Public title Efficacy of automated carbon dioxide insufflation in CT colonography
Acronym Efficacy of automated carbon dioxide insufflation in CTC
Scientific Title Efficacy of automated carbon dioxide insufflation in CT colonography
Scientific Title:Acronym Efficacy of automated carbon dioxide insufflation in CTC
Region
Japan

Condition
Condition Healthy individual
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy of automated carbon dioxide insufflation in CT colonography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of colon and small intestine distension per segment.
Key secondary outcomes Data on perceived burden of CT colonography were collected using visual analogue scale (VAS) and a questionnaire.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 CT colonography using automated carbon dioxide insufflation.
Interventions/Control_2 CT colonography using manual carbon dioxide insufflation.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy individual.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 40 years or older.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria 1) Patients with inflammatory bowel disease.
2) Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
3) Contraindication for using Buscopan.
4) Previous colorectal surgery.
5) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
6) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
7) Possibility of pregnancy.
8) Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
9) Claustrophobia.
10) Severe deafness.
11) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Nagata MD PhD
Organization Sakakibara Sapia Tower Clinic
Division name Radiology Section
Zip code
Address 1-7-12 Sapiatower 7F, Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL 03-5288-0011
Email Nagata7@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Nagata MD PhD
Organization Sakakibara Sapia Tower Clinic
Division name Radiology Section
Zip code
Address 1-7-12 Sapiatower 7F, Marunouchi, Chiyoda-ku, Tokyo 100-0005, Japan
TEL 03-5288-0011
Homepage URL
Email Nagata7@aol.com

Sponsor
Institute Sakakibara Sapia Tower Clinic
Institute
Department

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
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 榊原サピアタワークリニック（東京都）

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jsgcs/51/4/51_465/_article/-char/ja/
Number of participants that the trial has enrolled
Results 
Automated insufflation significantly improved distention overall compared to manual insufflation. No significant difference was seen in Visual Analogue Scale between manual insufflation and automated insufflation. 
Automated carbon dioxide insufflation significantly improved colonic distention compared to manual insufflation. Participant acceptance was similar to that for manual insufflation.
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 Main results already published
Date of protocol fixation
2012 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2013 Year 01 Month 30 Day
Date of closure to data entry
2013 Year 02 Month 28 Day
Date trial data considered complete
2013 Year 03 Month 30 Day
Date analysis concluded
2013 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 07 Day
Last modified on
2014 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010901

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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