UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018575 |
|---|---|
| Receipt number | R000021500 |
| Scientific Title | Validity and Safety of Colonoscopy in Patients Aged 85 Years or Older |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2020/08/10 08:19:12 |
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Basic information
Public title
Validity and Safety of Colonoscopy in Patients Aged 85 Years or Older
Acronym
Colonoscopy for the Elderly
Scientific Title
Validity and Safety of Colonoscopy in Patients Aged 85 Years or Older
Scientific Title:Acronym
Colonoscopy for the Elderly
Region
| Japan |
Condition
Condition
Patients aged 85 years or older, who received colonoscopy
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the validity and safety of colonoscopy in patients aged 85 years and older.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of colonoscopy, prevalence of colorectal lesions detected, adverse events associated with colonoscopy and patient outcome.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients able to complete bowel preparation with lavage by themselves, but emergency patients unable to complete this were also included.
Key exclusion criteria
Patients unable to complete bowel preparation with lavage by themselves.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Aizu Medical Center
Zip code
969-3492
Address
Aizuwakamatsu-city, Fukushima
TEL
0242752100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Isohata |
Organization
Fukushima Medical University
Division name
Aizu Medical Center
Zip code
969-3492
Address
Aizuwakamatsu-city, Fukushima
TEL
0242752100
Homepage URL
nisohata@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
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hibarigaoka, Fukushima-city, Fukushima
Tel
0245471825
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
福島県立医科大学会津医療センター（福島県）
東京女子医科大学東医療センター（東京都）
自治医科大学さいたま医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
DOI: 10.23922/jarc.2018-014
Publication of results
Published
Result
URL related to results and publications
DOI: 10.23922/jarc.2018-014
Number of participants that the trial has enrolled
177
Results
Colonoscopy for patients aged 85 years or older was safe and effective but may not be effective for the purpose of the surveillance or screening of mild abdominal symptom.
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients 85y or older, who underwent colonoscopy between September 2010 and August 2012 in two tertiary-care hospitals in Japan
Participant flow
Retrospective analysis
Adverse events
None
Outcome measures
Main outcome measures were cecal intubation rate, detection rate of adenomas and cancers, treatment, adverse events, and long-term outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Medical chart review for the elderly patients aged 85 years or older, who underwent colonoscopy from September 2010 to August 2012. Main outcomes have been described in the other area. No confounding factors are used for the adjustment.
Management information
Registered date
| 2015 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021500
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/12 | 101 研究計画書（別紙様式１）高齢者大腸鏡.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/02/12 | Supplementary Table 1.pdf |
