UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Title of the study (Brief title)	L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Region	Japan

Condition
Condition	Colorectal neoplasmas
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and safety of L-menthol spray as an antiperistaltic agent with carbon dioxide insufflation and their effects on adenoma detection rate during colonoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The colorectal adenoma detection rate between the L-menthol with carbon dioxide group and the placebo group.
Key secondary outcomes	The proportion of patients with no peristalsis, the withdrawal time and the pain during colonoscopy between the L-menthol with carbon dioxide group and the placebo group.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	0.8% l-Menthol with Carbon dioxide
Interventions/Control_2	0.8% l-Menthol with Air
Interventions/Control_3	Water with dimeticon with Carbon dioxide
Interventions/Control_4	Water with dimeticon with Air
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	The patients undergoing colonoscopy for the investigation of positive results of a fecal occult blood test screening, screening colonoscopy or surveillance colonoscopy after postendoscopic resection of colorectal neoplasmas.
Key exclusion criteria	Patients were excluded if they had any of the following: a history of colectomy,symptoms suggesting possible colorectal stenosis or cancer, inflammatory bowel disease, familial polyposis, or known CRC, severe organ failure, noncorrectable coagulopathy, or antithrombotic therapy.
Target sample size	600

Research contact person
Name of lead principal investigator	Takashi Okuda
Organization	Fukuchiyama City Hospital
Division name	Gastroenterology and Hepatology
Address	231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL	+81-773-22-2101
Email	okudatti@koto.kpu-m.ac.jp

Public contact
Name of contact person	Ken Inoue
Organization	Fukuchiyama City Hospital
Division name	Gastroenterology and Hepatology
Address	231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL	+81-773-22-2101
Homepage URL
Email	keninoue71@koto.kpu-m.ac.jp

Sponsor
Institute	Division of Gastroenterology and Hepatology,Fukuchiyama City Hospital
Institute
Department

Funding Source
Organization	Division of Gastroenterology and Hepatology,Fukuchiyama City Hospital
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	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 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 01 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	2016 Year 07 Month 28 Day
Last modified on	2018 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026946