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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018575
Receipt No. 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

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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
Email 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
Email nisohata@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

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
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
URL(English) https://upload.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


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