UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024026 |
|---|---|
| Receipt number | 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 | 2020/09/02 23:33:02 |
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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
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
makamura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology,Nagoya University graduate school of medeicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
600
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
Main results already published
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
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027627
