UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000010362
Receipt No. 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 (Ver. 12)

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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
Email 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
Email togashik@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012122