UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027627