UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010362 |
|---|---|
| Receipt number | R000012122 |
| Scientific Title | Research on standardization of colonoscopy using an ultra-thin instrument |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2019/06/13 15:30:28 |
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Basic information
Public title
Research on standardization of colonoscopy using an ultra-thin instrument
Acronym
Colonoscopy using an ultra-thin instrument
Scientific Title
Research on standardization of colonoscopy using an ultra-thin instrument
Scientific Title:Acronym
Colonoscopy using an ultra-thin instrument
Region
| Japan |
Condition
Condition
colorectal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examin cecal intubation rate, tolerability and adenoma detection rate of colonoscopy using ultra-thin instrument.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
tolerability using numerical rating scale
Key secondary outcomes
cecal intubation rate, cecal intubation time, terminal ileum intubation rate, adenoma detection rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
standard thin scope
Interventions/Control_2
ultra thin scope
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who need to receive colonoscopy
Key exclusion criteria
history of colorectal resection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Preparatory Office for Aizu Medical Center
Zip code
329-0434
Address
Aizuwakamatsu, Fukushima
TEL
0242-27-2151
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Prefectural Aizu General Hospital
Division name
Department of Coloproctology
Zip code
329-0434
Address
Shiromae 10, Aizuwakamatsu
TEL
0242-27-2151
Homepage URL
togashik@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-city
Tel
0245471111
rs@fmu.ac.jp
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
福島県立会津総合病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27859645
Number of participants that the trial has enrolled
Results
RESULTS:
There was a significant difference in reported pain using the numerical rating scale (median, UTC 1 vs PDC 4, P < 0.0001). Cecal intubation rates were 97.4% in UTC and 92.1% in PDC (P = 0.36), and ileal intubation rates were 82.0% and 89.4% (P = 0.76), respectively. However, median times to cecum were significantly longer using UTC compared with PDC (15.2 min vs 11.1 min, P = 0.022). Adenoma detection rates were 30.7% in UTC and 26.3% in PDC (P = 0.80).
CONCLUSIONS:
Colonoscopy using UTC was almost equivalent to that of PDC in older female patients, with significantly less pain compared with PDC. UTC may be an alternative to PDC for the difficult colon.
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
| 2012 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Dig Endosc. 2016 Nov 10. doi: 10.1111/den.12761. [Epub ahead of print]
Management information
Registered date
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012122
