UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026162 |
|---|---|
| Receipt number | R000030064 |
| Scientific Title | Colonic distention in CT colonography: supine/prone versus bilateral decubitus scanning |
| Date of disclosure of the study information | 2017/02/16 |
| Last modified on | 2019/02/18 14:59:14 |
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Basic information
Public title
Colonic distention in CT colonography: supine/prone versus bilateral decubitus scanning
Acronym
Colonic distention in CT colonography: supine/prone versus bilateral decubitus scanning
Scientific Title
Colonic distention in CT colonography: supine/prone versus bilateral decubitus scanning
Scientific Title:Acronym
Colonic distention in CT colonography: supine/prone versus bilateral decubitus scanning
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of scanning positions 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 distension per segment using a 4-point scale.
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 -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
CT colonography scanning with supine and prone positions
Interventions/Control_2
CT colonography scanning with left and right lateral decubitus positions
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
| 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 20 years or older.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria
1) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
2) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
3) Possibility of pregnancy.
4) Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
5) Claustrophobia.
6) Iodine hypersensitivity.
7) Severe thyroid disease.
8) Severe deafness.
9) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata M.D Ph.D. |
Organization
National Cancer Center
Division name
Division of Screening Technology, Center for Public Health Science
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL
+81-3-3542-2511
Nagata7@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Takahashi |
Organization
National Cancer Center
Division name
Division of Screening Assessment and Management, Center for Public Health Science
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL
+81-3-3542-2511
Homepage URL
noritaka@ncc.go.jp
Sponsor or person
Institute
Sakakibara Sapia Tower Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center
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
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
| 2017 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1259/bjr.20180538
Number of participants that the trial has enrolled
Results
OBJECTIVE:
To prospectively evaluate and complete the colonic distention and patient acceptance of CT colonography (CTC) in the supine/prone and left/right lateral positions.
METHODS:
A total of 220 consecutive patients were alternately allocated to the supine/prone positioning or left/right lateral positioning group. Two readers scored the degree of colonic distention by segment using a 4-point Likert scale (4 = optimal, 3 = adequate, 2 = inadequate, 1 = collapsed). In addition, patients were asked to rate the discomfort due to positioning during each scan using a 3-point animated face scale (3 = difficult, 2 = somewhat unacceptable, 1 = easy).
RESULTS:
The overall mean colonic distention scores for supine, prone, left lateral, and right lateral positions were 3.16, 3.29, 3.22, and 3.42, respectively. Of all, the right lateral position provided the best colonic distention (p < 0.01). Combined left lateral and right lateral positions provided more adequately distended segments compared with combined supine and prone positions (95.6% vs 90.7 %, respectively, p < 0.01). Patient acceptance was significantly lower in the prone position compared to other positions; however there was no difference in patient acceptance between the supine and left/right lateral positions.
CONCLUSION:
Right lateral positioning provided the best colonic distention and good patient acceptance.
ADVANCES IN KNOWLEDGE:
The left/right lateral position should be considered for routine CTC positioning protocols.
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
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Takahashi, N., Nagata, K., Iyama, A., Mikami, T., Kanazawa, H., & Saito, H. (2019). Colonic distention and patient acceptance of CT colonography: supine/prone vs left/right lateral scanning. The British journal of radiology, 92(1093), 20180538.
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030064
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