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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024026
Receipt No. R000027627
Scientific Title Prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy
Date of disclosure of the study information 2016/09/30
Last modified on 2019/04/09

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Basic information
Public title Prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy
Acronym Prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy
Scientific Title Prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy
Scientific Title:Acronym Prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy
Region
Japan

Condition
Condition Bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the factor of patient's pain and difficult for colonoscopy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between the insertion difficulty by endoscopist and patient factors.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undegoing colonoscopy
Key exclusion criteria (A) Patients with severe acute inflammation
(B) The pregnant patient
(C) Patients at risk of performing an endoscopic examination exceed the usefulness, such as when general condition is very poor.
(D) patients with heart, lung, kidney, serious dysfunction in liver
(E) Patient with no self-judgment ability
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name masanao
Middle name
Last name nakamura
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, aichi
TEL 052-741-2172
Email makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name masanao
Middle name
Last name nakamura
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya,aichi
TEL 052-741-2172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology,Nagoya University graduate school of medeicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology,Nagoya University graduate school of medeicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya university hospital
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
Tel 052-741-2172
Email ethic@med.nagoya-u.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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 13 Day
Date of IRB
2016 Year 05 Month 25 Day
Anticipated trial start date
2016 Year 09 Month 30 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is prospective study of the evaluation for the relation between patient's pain and difficult colonoscopy.

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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