UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Title of the study (Brief title)	Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the efficacy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical recurrence rate in one week after the colonoscopy
Key secondary outcomes	Clinical recurrence rate in eight week after the colonoscopy Transition of vital sign and symptom before and after the colonoscopy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Colonosocopy using carbon dioxide insufflation
Interventions/Control_2	Colonosocopy using air insufflation
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with clinical remission
Key exclusion criteria	- Post history of colectomy - Patients with total parenteral nutrition(TPN) - Patients with chronic obstructive pulmonary disease(COPD) - Patients with serious heart disease - Patients who are planing to perform colonoscopy with intravenous anesthesia
Target sample size	250

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University, Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Satoshi Hiyama
Organization	Osaka University, Graduate School of Medicine
Division name	Department of Therapeuitcs for Inflammatory Bowel Diseasesd Hepatology
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3621
Homepage URL	http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
Email	s-hiyama@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	YES
Study ID_1	14372
Org. issuing International ID_1	Ethics Committee of Osaka University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 27 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 12 Day
Anticipated trial start date	2015 Year 08 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 25 Day
Last modified on	2016 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021753