UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008690 |
|---|---|
| Receipt number | R000010216 |
| Scientific Title | Efficacy of automated carbon dioxide insufflation and IV Buscopan as a muscle relaxant in computed tomography colonography. |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2014/12/27 10:20:48 |
* 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
Efficacy of automated carbon dioxide insufflation and IV Buscopan as a muscle relaxant in computed tomography colonography.
Acronym
Efficacy of automated CO2 insufflation and IV Buscopan in CT colonography
Scientific Title
Efficacy of automated carbon dioxide insufflation and IV Buscopan as a muscle relaxant in computed tomography colonography.
Scientific Title:Acronym
Efficacy of automated CO2 insufflation and IV Buscopan in CT colonography
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 and IV Buscopan as a muscle relaxant in computed tomography 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 using a 4-point scale (prone and supine).
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
Double blind -all involved 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
4
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Automated carbon dioxide insufflation with intravenous injection of butyl scopolamine (Buscopan)
Interventions/Control_2
Manual carbon dioxide insufflation without butyl scopolamine (Buscopan)
Interventions/Control_3
Manual carbon dioxide insufflation with intravenous injection of butyl scopolamine (Buscopan)
Interventions/Control_4
Automated carbon dioxide insufflation without butyl scopolamine (Buscopan)
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 colonoscopy 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
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata M.D PhD |
Organization
Kameda Medical Center Makuhari
Division name
Department of Gastroenterology
Zip code
Address
1-3 CD2, Nakase, Mihama-ku, Chiba, 261-8501, Japan
TEL
043-296-2711
Nagata7@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata M.D PhD |
Organization
Kameda Medical Center Makuhari
Division name
Department of Gastroenterology
Zip code
Address
1-3 CD2, Nakase, Mihama-ku, Chiba, 261-8501, Japan
TEL
043-296-2711
Homepage URL
Nagata7@aol.com
Sponsor or person
Institute
Kameda Medical Center Makuhari
Institute
Department
Personal name
Funding Source
Organization
Kameda Medical Center Makuhari
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
EIDIA Co., Ltd.
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
亀田メディカルセンター幕張（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ajronline.org/doi/abs/10.2214/AJR.14.12772
Number of participants that the trial has enrolled
Results
OBJECTIVE
The purpose of this article is to evaluate the efficacy of IV hyoscine butylbromide as a bowel relaxant and automated carbon dioxide insufflation in CT colonography in terms of colonic distention and perceived burden.
SUBJECTS AND METHODS
Two hundred twenty-four participants were randomly allocated to one of four groups: control (no bowel relaxant and IV saline placebo before CT colonography with manual carbon dioxide insufflation), hyoscine butylbromide (IV hyoscine butylbromide before examination with manual carbon dioxide insufflation), automated (no bowel relaxant before examination with automated carbon dioxide insufflation), and combined (hyoscine butylbromide before examination with automated carbon dioxide insufflation). The degree of colonic distention on a 4-point scale, examination time, and participants' satisfaction, as measured by their responses to a questionnaire, were assessed.
RESULTS
The mean distention grades of all the colonic segments and both positions were 3.22 in the control group, 3.28 in the hyoscine butylbromide group, 3.77 in the automated group, and 3.74 in the combined group. Compared with manual carbon dioxide insufflation, automated carbon dioxide insufflation significantly improved the clinical adequacy of colonic distention and shortened examination time. No statistically significant difference was seen in the clinical adequacy of distention between participants who received hyoscine butylbromide and those who did not, or in examination time. Overall, the participants' experiences were not different.
CONCLUSION
Colonic distention was statistically significantly improved by automated carbon dioxide insufflation, but not by the administration of hyoscine butylbromide. The participants' tolerance was similar in each group.
Read More: http://www.ajronline.org/doi/abs/10.2214/AJR.14.12772
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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010216
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
